510(k) Device Clearances
Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.
15,000 total clearances
PrecisionTAVI (v1.1)
Dasi Simulations
Extended Reservoir; MiniMed Reservoir
Medtronic Minimed
UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE; UMED REPROCESSED AIRCAST ELITE
United Medical Resources, LLC
BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)
Becton, Dickinson and Company
MatriDerm pluS+ Bi-Layer
Medskin Solutions Dr. Suwelack AG
Revolve Surgical System
Revolve Surgical, Inc.
Vital Signs Monitor
Beijing Choice Electronic Technology Co., Ltd.
CHIRAVAC Blood Collection Needles
Chirana T. Injecta
Tornier Humeral Reconstruction System Max (Tornier HRS Max)
Tornier, Inc.
White Endoseal MTA
Maruchi
ELEC-LED
Micro-Nx Co., Ltd.
SB Knife Jr2 (MD-47702 and MD-47702L)
Sb-Kawasumi Laboratories, Inc.
FERTI-LILY Conception Cup
Rosesta Medical BV
Trinias
Shimadzu Corporation
Spectricept Skin and Wound Cleanser
Spectrum Antimicrobials, Inc.
Medline Safety Insulin and TB Syringes
Medline Industries, LP
BLUE 400; BLUE 400 S
Carl Zeiss Meditec, AG
ACUSON Sequoia Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW
Huizhou Tianchang Industrial Co., Ltd.
Cohitech Reusable Tampon Applicator
Cotton High Tech S.L.
BTL-99-OC
BTL Industries, Inc.
Disposable Vinyl Examination Gloves
Viet Phu Trade and Import Export Co., Ltd.
Fusion FibFix Nail
Fusion Orthopedics USA, LLC
Cios Alpha; Cios Flow
Siemens Medical Solutions USA, Inc.
Ziehm Vision RFD
Ziehm Imaging GmbH
MTONE EVO (MTONE EVO)
M&T S.R.L.
Surgical Face Mask
Shanghai Yunqing Industrial Co., Ltd.
Multi-Unit DAS System
Talladium España, SL
TMINI Miniature Robotic System
THINK Surgical, Inc.
Mindray SV600 Ventilator, Mindray SV800 Ventilator
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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