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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
54313–54336 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 2009
ENDOTRACHEAL TUBE
K080105 · BTR
Chilecom Medical Devices Co., Ltd.
Anesthesiology · 396d
Cleared Feb 13, 2009
MEDTOXSCAN
K080635 · DKZ
Medtox Diagnostics, Inc.
Chemistry · 344d
Cleared Feb 13, 2009
DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100
K080636 · CGA
Hubdic Co., Ltd.
Chemistry · 344d
Cleared Feb 13, 2009
STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002
K081264 · FMQ
Children'S Health First, Inc.
General Hospital · 284d
Cleared Feb 13, 2009
FLU-ADMIN, MODELS 60150, 60150C, 60151C, 60153C, 60160
K082027 · FPA
Genesis Bps, LLC
General Hospital · 211d
Cleared Feb 13, 2009
TERUMO ROCSAFE HYBRID PERFUSION SYSTEM
K082321 · KFM
Terumo Cardiovascular Systems Corp.
Cardiovascular · 184d
Cleared Feb 13, 2009
CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE
K082930 · DXC
Cardiva Medical, Inc.
Cardiovascular · 135d
Cleared Feb 13, 2009
MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH...
K082988 · FEB
Medivators Reprocessing Systems
General Hospital · 129d
Cleared Feb 13, 2009
PALOMAR ASPIRE LASER PLATFORM
K083165 · GEX
Palomar Medical Products, Inc.
General & Plastic Surgery · 109d
Cleared Feb 13, 2009
REVAC AUTO RETRACTABLE SAFETY SYRINGE
K083193 · FMF
Revolutions Medical Corporation, Inc.
General Hospital · 107d
Cleared Feb 13, 2009
NOBELACTIVE 8.5 MM & 18.0 MM
K083205 · DZE
Nobel Biocare AB
Dental · 106d
Cleared Feb 13, 2009
ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33
K083309 · DQD
Zargis Medical Corp.
Cardiovascular · 95d
Cleared Feb 13, 2009
BIFIX SE
K083438 · EMA
Voco GmbH
Dental · 85d
Cleared Feb 13, 2009
TACTIPEN
K083457 · FMF
Haselmeier GmbH
General Hospital · 84d
Cleared Feb 13, 2009
METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000
K083469 · KWD
Metasurg
Orthopedic · 81d
Cleared Feb 13, 2009
LUCENT MAGNUM
K083475 · OVD
Spinal Elements, Inc.
Orthopedic · 81d
Cleared Feb 13, 2009
DRAD30003/RADREX-I
K083503 · KPR
Toshiba America Medical Systems, In.C
Radiology · 79d
Cleared Feb 13, 2009
MAMMODIAGNOST VU
K083740 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 59d
Cleared Feb 13, 2009
ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES
K083827 · KRO
Biomet Manufacturing Corp
Orthopedic · 52d
Cleared Feb 13, 2009
CARDIAC TRIGGER, MODEL: CTM300
K083854 · DRT
Ivy Biomedical Systems, Inc.
Cardiovascular · 51d
Cleared Feb 13, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K090016 · LYZ
Suqian Clean Glove Co., Ltd.
General Hospital · 42d
Cleared Feb 13, 2009
AIRSTRIP OB
K090269 · HGM
Airstrip Technologies, LP
Obstetrics & Gynecology · 10d
Cleared Feb 12, 2009
NUBRACE INVISIBLE REMOVABLE ORTHODONTICS
K073121 · NXC
Nubrace, Inc.
Dental · 465d
Cleared Feb 12, 2009
MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-200
K082565 · NEY
Microsurgeon, Inc.
General & Plastic Surgery · 161d