Search FDA 510(k) Database

6,800 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
14065–14088 of 174,061
Cleared Nov 01, 2021
SterileRight sterilization pouch and roll
K212338 · FRG
Sterileright Packaging Mfg., Inc.
General Hospital · 97d
Cleared Nov 01, 2021
DePuy CONDUIT LLIF Angled Inserters
K212823 · MAX
Enztec Limited
Orthopedic · 59d
Cleared Nov 01, 2021
Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA,...
K212948 · NGX
Guangzhou Xinbo Electronic Co., Ltd.
Physical Medicine · 46d
Cleared Oct 31, 2021
Black Nitrile Powder Free Patient Examination Glove, Non Sterile
K210588 · LZA
Onetexx Sdn Bhd
General Hospital · 247d
Cleared Oct 30, 2021
Tracheal Stent System (Y-Shaped)
K212403 · JCT
Micro-Tech (Nanjing) Co., Ltd.
Anesthesiology · 89d
Cleared Oct 29, 2021
Phoenix Digital Thermometer
K201032 · FLL
Phoenix Innovative Healthcare...
General Hospital · 557d
Cleared Oct 29, 2021
N Latex FLC kappa, N Latex FLC lambda
K201496 · DFH
Siemens Healthcare Diagnostics...
Immunology · 511d
Cleared Oct 29, 2021
Enbio S
K210279 · FLE
Enbio Group AG
General Hospital · 270d
Cleared Oct 29, 2021
TraumaGuard Intra-abdominal Pressure Sensing System
K210570 · PHU
Sentinel Medical Technologies, LLC
General & Plastic Surgery · 245d
Cleared Oct 29, 2021
nView s1 with nav option
K211064 · OWB
Nview Medical
Radiology · 203d
Cleared Oct 29, 2021
Critical Care Suite with Endotracheal Tube Positing AI algorithm
K211161 · QIH
Ge Medical Systems, LLC
Radiology · 193d
Cleared Oct 29, 2021
ATEC Alignment App
K211987 · LLZ
Alphatec Spine, Inc.
Radiology · 123d
Cleared Oct 29, 2021
SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue...
K212308 · LZA
Srirungruang Global Co., Ltd.
General Hospital · 98d
Cleared Oct 29, 2021
Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF
K212389 · MAX
Intelivation, LLC
Orthopedic · 88d
Cleared Oct 29, 2021
MectaLIF Extension
K212831 · MAX
Medacta International S.A.
Orthopedic · 52d
Cleared Oct 29, 2021
VersaWrap
K213163 · FTM
Alafair Biosciences, Inc.
General & Plastic Surgery · 31d
Cleared Oct 29, 2021
Balloon BS-3
K213195 · FDA
Fujifilm Corporation
Gastroenterology & Urology · 30d
Cleared Oct 29, 2021
CARTO 3 EP Navigation System Version 7.2
K213264 · DQK
Biosense Webster, Inc.
Cardiovascular · 29d
Cleared Oct 29, 2021
ds Head 32ch 3.0T
K213351 · MOS
Invivo Corporation (Business Trade...
Radiology · 21d
Cleared Oct 28, 2021
APAS Independence with IC Chromogenic MRSA BD Analysis Module
K200839 · QQY
Clever Culture Systems
Microbiology · 576d
Cleared Oct 28, 2021
VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)
K210287 · LON
bioMerieux, Inc.
Microbiology · 268d
Cleared Oct 28, 2021
Disposable Monopolar Laparoscopic Tips and Reusable Handles
K211019 · GEI
Dannik, LLC
General & Plastic Surgery · 206d
Cleared Oct 28, 2021
EndoTool SubQ 2.1
K211160 · NDC
Monarch Medical Technologies, LLC
Chemistry · 192d
Cleared Oct 28, 2021
Disposable Nitrile Examination Gloves (Powder free, Blue)
K211581 · LZA
Leping Shengde Medical Technology...
General Hospital · 160d