Cook Incorporated
88 FDA actions
Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures
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Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, s
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Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214
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COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference
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Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G321
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COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number
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COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part
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COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA,
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COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part
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COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44
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COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983; R
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COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786
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COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242
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COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Or
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COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775
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COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Ord
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COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Refere
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COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Pa
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COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Refer
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COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order N
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COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073
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Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-4
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R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The R¿sch-Uchida Transjugular Liver Ac
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Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2) RTPS-100-10.0; The Ring Trans
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Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are
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Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08
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Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08
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Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and
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Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
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Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-
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Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18
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Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers ar
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Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drai
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Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous
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Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end ca
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Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for v
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Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to
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Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or t
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Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular a
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Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for va
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Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneou
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Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0
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Nest VT Vitrification Device
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Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G577
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Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695)
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Gunther Tulip Vena Cava Filter Retrieval Set
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Bakri Essential Postpartum Balloon
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Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: TSCF-25-180-3 G01602 TSCF-35-180-3 G009
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Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60-0-3 G11949 C-HDOC-18-40-0-2
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Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU14.0-40-ST G02327 CTU14.0-3
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Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA
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Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB
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Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G06866
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Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G017
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Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801) T
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Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 TSCF-25-80-3 G00476
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Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3 G00362 C-TDOC-18-50-0-2 G05146
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Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183
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Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G07304
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Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-0-5 G34131 RPC-0351
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Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534
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Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80 (GPN G013
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Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG G27031 THSF-35-145-THG G2703
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Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN TMT-35-145 G01677
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Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041)
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Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356 THSF-38-145-COONS G02
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Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678
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Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914
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Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF-18-30 G02261 C-SF-25-40 G01937 TSF-18-26
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Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145 G09607
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Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN: PMG-18SP-60-COPE-NT-ST G09395 PMG-18
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Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 ORDER NUMBER (GPN): G56176. F
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Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER NUMBER (GPN) G07516. For vascul
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Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518. For vascul
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Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (GPN): G56151. F
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Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152.
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Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150 ORDER NUMBER (GPN):G56161. For
Cook Incorporated
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G07937. For vascula
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Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER (GPN):G56149. For
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Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-150 ORDER NUMBER (GPN): G56173.
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Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-80 ORDER NUMBER (GPN): G56162. For
Cook Incorporated
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RFSPC-35-180 ORDER NUMBER (GPN) G09608. For vasc
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Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-80 ORDER NUMBER (GPN): G56175. Fo
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Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-80 ORDER NUMBER (GPN): G56172. F
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Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
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Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NE
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Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE
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Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)
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