Merit Medical Systems, Inc.
117 FDA actions
Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690
Merit Medical Systems, Inc.
StatSeal Disc
Merit Medical Systems, Inc.
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Merit Medical Systems, Inc.
Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY
Merit Medical Systems, Inc.
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Merit Medical Systems, Inc.
CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K
Merit Medical Systems, Inc.
ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C,
Merit Medical Systems, Inc.
16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
Merit Medical Systems, Inc.
BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H96
Merit Medical Systems, Inc.
DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H7871030
Merit Medical Systems, Inc.
STAR RF Ablation System
Merit Medical Systems, Inc.
Allwell Inflation Device, for angiographic use REF: IS-30-A
Merit Medical Systems, Inc.
Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130
Merit Medical Systems, Inc.
Merit Medical , Custom Manifold Kit REF: K09-13203A
Merit Medical Systems, Inc.
Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
Merit Medical Systems, Inc.
Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05
Merit Medical Systems, Inc.
Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
Merit Medical Systems, Inc.
Allwell Angioplasty Pack REF: IS-30-B1/B
Merit Medical Systems, Inc.
SCOUT MD Surgical Guidance System
Merit Medical Systems, Inc.
PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A,
Merit Medical Systems, Inc.
10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 /
Merit Medical Systems, Inc.
Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-1334
Merit Medical Systems, Inc.
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
Merit Medical Systems, Inc.
High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C
Merit Medical Systems, Inc.
Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
Merit Medical Systems, Inc.
Resilience Fully Covered Esophageal Stent System
Merit Medical Systems, Inc.
Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
Merit Medical Systems, Inc.
Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Ca
Merit Medical Systems, Inc.
Prelude Wave Hydrophilic Sheath Introducer
Merit Medical Systems, Inc.
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Merit Medical Systems, Inc.
Micro Ace Gold Advanced Micro Access System
Merit Medical Systems, Inc.
Ventrax Delivery System
Merit Medical Systems, Inc.
basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C
Merit Medical Systems, Inc.
Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM M
Merit Medical Systems, Inc.
Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410
Merit Medical Systems, Inc.
basixSKY Inflation Device, REF: SKY1802
Merit Medical Systems, Inc.
Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF
Merit Medical Systems, Inc.
MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B
Merit Medical Systems, Inc.
DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A
Merit Medical Systems, Inc.
Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 3
Merit Medical Systems, Inc.
Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C
Merit Medical Systems, Inc.
Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430 Injecto
Merit Medical Systems, Inc.
BlueFIRE Inflation Device, REF: IN10140
Merit Medical Systems, Inc.
Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330 Injec
Merit Medical Systems, Inc.
basixTOUCH Inflation Device, REF: IN8140/A
Merit Medical Systems, Inc.
StabiliT TOUCH Syringe, REF: IN8VCF/B
Merit Medical Systems, Inc.
IntelliSystem Inflation Device, REF: IN1525/D
Merit Medical Systems, Inc.
Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230 In
Merit Medical Systems, Inc.
Custom Procedure Kit, REF: K12T-11077
Merit Medical Systems, Inc.
Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rap
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Pre
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K22
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: PC
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K09
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K11
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Saf
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Cus
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: ReS
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Cus
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K10
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Pre
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K02
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Saf
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Out
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Pre
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Saf
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Cus
Merit Medical Systems, Inc.
Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S
Merit Medical Systems, Inc.
Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
Merit Medical Systems, Inc.
Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY
Merit Medical Systems, Inc.
Impress Angiographic Catheter
Merit Medical Systems, Inc.
Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)
Merit Medical Systems, Inc.
Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC2
Merit Medical Systems, Inc.
Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILE
Merit Medical Systems, Inc.
Fountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLY
Merit Medical Systems, Inc.
Bearing nsPVA Express
Merit Medical Systems, Inc.
Mighty Wire Guide Wire
Merit Medical Systems, Inc.
Micro Ace Advanced Micro Access System
Merit Medical Systems, Inc.
Ventrax Delivery System (VTR851)
Merit Medical Systems, Inc.
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only
Merit Medical Systems, Inc.
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution only
Merit Medical Systems, Inc.
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution only
Merit Medical Systems, Inc.
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only
Merit Medical Systems, Inc.
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution only
Merit Medical Systems, Inc.
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx Only
Merit Medical Systems, Inc.
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only
Merit Medical Systems, Inc.
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only
Merit Medical Systems, Inc.
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile EO, Rx Only
Merit Medical Systems, Inc.
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only
Merit Medical Systems, Inc.
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE EO, Rx Only *EU Distribution only
Merit Medical Systems, Inc.
Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only
Merit Medical Systems, Inc.
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile EO, Rx Only
Merit Medical Systems, Inc.
COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
Merit Medical Systems, Inc.
Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
Merit Medical Systems, Inc.
Aspira Pleural Drainage System
Merit Medical Systems, Inc.
Low Profile Companion Sheath
Merit Medical Systems, Inc.
CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B, CORA1815/
Merit Medical Systems, Inc.
CorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B, CORA1415/B, CORA1615S/B, CORA2010S/B, CORCA1410S/B, CORCA
Merit Medical Systems, Inc.
HeRO Graft
Merit Medical Systems, Inc.
AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B
Merit Medical Systems, Inc.
Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001, IN8112/C, K05-00053H, K05-00109G, K05-00137K, K05-00410G
Merit Medical Systems, Inc.
SCOUT BX Delivery System
Merit Medical Systems, Inc.
Elation Pulmonary Balloon Dilation Catheter
Merit Medical Systems, Inc.
Aspira Peritoneal Drainage System
Merit Medical Systems, Inc.
ASAP Aspiration Catheter, ASAPLP Aspiration Catheter
Merit Medical Systems, Inc.
Prelude Guide Sheath
Merit Medical Systems, Inc.
Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Onl
Merit Medical Systems, Inc.
MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm),
Merit Medical Systems, Inc.
Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only,
Merit Medical Systems, Inc.
basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or othe
Merit Medical Systems, Inc.
SwiftNINJA Steerable Microcatheter
Merit Medical Systems, Inc.