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
32137–32160 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 2016
True HD 3MOS Camera System
K161017 · GCJ
Conmed Corporation
General & Plastic Surgery · 27d
Cleared May 06, 2016
Diagnostic Station DS20
K152043 · DPS
Schiller AG
Cardiovascular · 288d
Cleared May 06, 2016
Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT,...
K152205 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 274d
Cleared May 06, 2016
Digital Blood Pressure Monitor
K152415 · DXN
Suzhou Sunspirit Co., Ltd.
Cardiovascular · 254d
Cleared May 06, 2016
TD-1035 Thermometer
K152680 · FLL
Taidoc Technology Corporation
General Hospital · 231d
Cleared May 06, 2016
Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit
K152717 · MQL
William A. Cook Australia Pty. , Ltd.
Obstetrics & Gynecology · 228d
Cleared May 06, 2016
FREMAP ELECTRODE
K152769 · ETN
Ad-Tech Medical Instrument Corporation
Ear, Nose, Throat · 224d
Cleared May 06, 2016
EarlySense Insight Sytem
K152911 · BZQ
Earlysense, Ltd.
Anesthesiology · 217d
Cleared May 06, 2016
Pulp Canal Sealer, Pulp Canal Sealer EWT
K152956 · KIF
Sybron Dental Specialties
Dental · 212d
Cleared May 06, 2016
INVISION Total Ankle Revision System
K153008 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 205d
Cleared May 06, 2016
TOUAREG CloseFit™ UNP 2.75mmD
K153111 · DZE
Adin Dental Implants Systems , Ltd.
Dental · 191d
Cleared May 06, 2016
Achieve ST Mapping Catheter, Catheter Connecting Cable
K153139 · DRF
Medtronic, Inc.
Cardiovascular · 189d
Cleared May 06, 2016
Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida...
K153506 · KNT
Consure Medical Pvt , Ltd.
Gastroenterology & Urology · 151d
Cleared May 06, 2016
NeoFuse HA Enhanced PLIF/TLIF
K153615 · MAX
Ht Medical, LLC
Orthopedic · 141d
Cleared May 06, 2016
Monopolar single-use HF cable
K160053 · GEI
Olympus Winter & Ibe GmbH
General & Plastic Surgery · 116d
Cleared May 06, 2016
Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology
K160740 · NLM
Surgical Instrument Service and...
Gastroenterology & Urology · 50d
Cleared May 05, 2016
ERBE ESU Model VIO dV with Accessories
K150364 · GEI
Erbe Elektromedizin GmbH
General & Plastic Surgery · 448d
Cleared May 05, 2016
HC Spinal System
K151362 · MNH
Hung Chun Bio-S Co., Ltd.
Orthopedic · 350d
Cleared May 05, 2016
Cogent Hemodynamic Monitoring System
K152006 · DXQ
Icu Medical, Inc.
Cardiovascular · 289d
Cleared May 05, 2016
Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit
K152682 · MQL
Willian A. Cook Australia Pty, Ltd.
Obstetrics & Gynecology · 230d
Cleared May 05, 2016
PeriFlux6000
K152930 · DPW
Perimed AB
Cardiovascular · 213d
Cleared May 05, 2016
Electronic Pulse Stimulator
K153520 · NUH
Jkh Health Co., Ltd.
Neurology · 149d
Cleared May 05, 2016
Flip Button Suture Anchor
K153585 · MBI
First Ray, LLC
Orthopedic · 141d
Cleared May 05, 2016
Enovare Ultrasound System
K153620 · IYO
Oreon Technologies, Inc.
Radiology · 139d