Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
50017–50040 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 2010
ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL...
K100818 · OMN
Meridian Bioscience, Inc.
Microbiology · 108d
Cleared Jul 09, 2010
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50...
K100907 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 99d
Cleared Jul 09, 2010
SPONDY SPINAL FIXATION SYSTEM
K100956 · MNH
Allure Spine LLC
Orthopedic · 93d
Cleared Jul 09, 2010
PULMOTRACK 5050 WHOLTER, MODEL 5050
K101022 · DSH
Karmelsonix
Cardiovascular · 87d
Cleared Jul 09, 2010
LOCI 8 CALIBRATOR, MODEL KC 646
K101460 · JIX
Siemens Healthcare Diagnostics
Chemistry · 44d
Cleared Jul 09, 2010
BD DIRECTIGEN EZ RSV
K101514 · GQG
Becton, Dickinson & CO
Microbiology · 37d
Cleared Jul 09, 2010
FIL 1520
K101629 · CAH
Glenn Medical Systems, Inc.
General Hospital · 29d
Cleared Jul 09, 2010
ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE
K101651 · NTE
Cordis Corp.
Cardiovascular · 28d
Cleared Jul 09, 2010
WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES
K101680 · DXN
Welch Allyn, Inc.
Cardiovascular · 24d
Cleared Jul 08, 2010
IMPELLA CONTROLLER
K093801 · KFM
Abiomed, Inc.
Cardiovascular · 210d
Cleared Jul 08, 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
K100057 · LYZ
Tangshan Kangyuan Glove Co., Ltd.
General Hospital · 181d
Cleared Jul 08, 2010
HM-LAMP II
K100234 · FTD
Hillusa, Inc.
General & Plastic Surgery · 163d
Cleared Jul 08, 2010
VISUMAX LASER KERATOME
K100253 · HQF
Carl Zeiss Meditec, AG
Ophthalmic · 161d
Cleared Jul 08, 2010
PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT
K100461 · NEW
Riverpoint Medical
General & Plastic Surgery · 140d
Cleared Jul 08, 2010
ZYNO Z-800 INFUSION SYSTEM MODEL Z-800
K100705 · FRN
Zyno Medical, LLC
General Hospital · 118d
Cleared Jul 08, 2010
CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX
K101032 · JWH
Cardo Medical, Inc.
Orthopedic · 85d
Cleared Jul 08, 2010
SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM
K101060 · ORY
Siesta Medical, Inc.
Dental · 84d
Cleared Jul 08, 2010
MODIFICATION TO:RADIUS SPINAL SYSTEM
K101144 · NKB
Stryker Spine
Orthopedic · 76d
Cleared Jul 08, 2010
THERACLEAR
K101415 · GEX
Theravant Corporation
General & Plastic Surgery · 49d
Cleared Jul 08, 2010
HI-TORQUE WINN GUIDE WIRE FAMILY
K101648 · DQX
Abbott Vascular, Inc.
Cardiovascular · 27d
Cleared Jul 07, 2010
XYLOS VESSEL GUARD
K100984 · OMR
Xylos Corporation
Cardiovascular · 90d
Cleared Jul 06, 2010
LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT,...
K091409 · NQX
Roche Molecular Systems, Inc.
Microbiology · 419d
Cleared Jul 06, 2010
NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS...
K093383 · OOI
bioMerieux, Inc.
Microbiology · 249d
Cleared Jul 06, 2010
INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT...
K100051 · DJG
Alfa Scientific Designs, Inc.
Toxicology · 179d