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

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175,820 results
37273–37296 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 26, 2014
CONFIRM BIOACTIVE
K133678 · MQV
Globus Medical, Inc.
Orthopedic · 270d
Cleared Aug 26, 2014
TENS
K133979 · NUH
Sunmas (H.K.) Trading Limited
Neurology · 243d
Cleared CT Aug 26, 2014
CAYA CONTOURED DIAPHRAGM
K140305 · HDW
Kessel Medintim GmbH
Obstetrics & Gynecology · 200d
Cleared Aug 26, 2014
DIOTECH LASER FIBER
K140458 · GEX
Diotech CO
General & Plastic Surgery · 183d
Cleared Aug 26, 2014
POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR
K141021 · LZA
Hl Rubber Industries Sdn Bhd
General Hospital · 127d
Cleared Aug 26, 2014
STRYKER STERI-SHIELD FLYTE HYBRID TOGAS
K141095 · FYA
Stryker Corporation
General Hospital · 120d
Cleared Aug 26, 2014
VERTIFORM POSTERIOR FIXATION SYSTEM
K141291 · NKB
Next Orthosurgical
Orthopedic · 99d
Cleared Aug 26, 2014
VixWin Platinum
K141451 · LLZ
Imaging Sciences International (Dba...
Radiology · 85d
Cleared Aug 26, 2014
PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO)
K141497 · EHD
Osstem Implant Co., Ltd.
Radiology · 81d
Cleared Aug 26, 2014
BASAL DIGITAL THERMOMETER
K141505 · FLL
K-Jump Health Co., Ltd.
General Hospital · 81d
Cleared Aug 25, 2014
STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
K133322 · FRC
Steritec Products Mfg Co, Inc.
General Hospital · 300d
Cleared Aug 25, 2014
3B RESMART BPAP 25A, BMC RESMART BPAP 25A
K133769 · BZD
3B Medical, Inc.
Anesthesiology · 257d
Cleared Aug 25, 2014
ORTHOHUB EXTERNAL FIXATOR SOFTWARE
K140550 · OSN
Orthohub, Inc.
Orthopedic · 174d
Cleared Aug 25, 2014
U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS
K141294 · HEB
Kimberly-Clark Corp.
Obstetrics & Gynecology · 98d
Cleared Aug 25, 2014
MEDELA THOPAZ+
K141553 · BTA
Medela AG
General & Plastic Surgery · 75d
Cleared Aug 25, 2014
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS
K142036 · FPA
B.Braun Medical, Inc.
General Hospital · 28d
Cleared Aug 25, 2014
CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE
K142044 · LCM
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 28d
Cleared Aug 22, 2014
LUBRIGYN CREAM
K132772 · NUC
Uniderm Farmaceutici Srl
Obstetrics & Gynecology · 351d
Cleared Aug 22, 2014
NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART...
K133592 · DZE
Neodent USA, Inc.
Dental · 273d
Cleared Aug 22, 2014
PRECEPTIS TYMPANOSTOMY TUBE INSERTER
K133921 · ETD
Preceptis Medical
Ear, Nose, Throat · 242d
Cleared Aug 22, 2014
VYNTUS/ SENTRYSUITE PRODUCT LINE
K133925 · BZC
Carefusion Germany 234 GmbH
Anesthesiology · 242d
Cleared Aug 22, 2014
PERSONAL KINETIGRAPH (PKG) SYSTEM
K140086 · GYD
Gkc Manufacturing Pty, Ltd.
Neurology · 220d
Cleared CT Aug 22, 2014
EPX-4440HD DIGITAL VIDEO PROCESSOR
K140149 · PEA
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 212d
Cleared Aug 22, 2014
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS...
K140210 · NBW
Bionime Corporation
Chemistry · 206d