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
55441–55464 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 2008
PASS 2 SPINAL SYSTEM
K082069 · MNI
Medicrea Technologies
Orthopedic · 73d
Cleared Oct 03, 2008
ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX,...
K082515 · KDI
Asahi Kasei Medical Co., Ltd.
Gastroenterology & Urology · 31d
Cleared Oct 03, 2008
QUART ARTERIAL FILTER WITH BIOLINE COATING
K082544 · DTM
Maquet Cardiopulmonary, AG
Cardiovascular · 30d
Cleared Oct 03, 2008
STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION
K082567 · HRY
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Oct 03, 2008
PASS LP SPINAL SYSTEM
K082577 · MNH
Medicrea Technologies
Orthopedic · 28d
Cleared Oct 03, 2008
INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30,...
K082633 · DSI
Philips Medizinsysteme Boeblingen...
Cardiovascular · 23d
Cleared Oct 02, 2008
6F PROXIS SYSTEM
K073700 · DQY
St. Jude Medical, Inc.
Cardiovascular · 276d
Cleared Oct 02, 2008
STRYKER ESSX WITH NAVIGATION MOUNT
K080052 · ERL
Stryker Corp.
Ear, Nose, Throat · 268d
Cleared Oct 02, 2008
LBI EMBOLECTOMY SYSTEM
K080901 · QEW
Lumen Biomedical, Inc.
Cardiovascular · 185d
Cleared Oct 02, 2008
ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30
K081545 · MSS
Advanced Medical Optics, Inc.
Ophthalmic · 122d
Cleared Oct 02, 2008
NUVASIVE COROENT SYSTEM
K081611 · ODP
Nuvasive, Inc.
Orthopedic · 115d
Cleared Oct 02, 2008
ATLAS SPINE SPACER
K081880 · ODP
Atlas Spine, Inc.
Orthopedic · 92d
Cleared Oct 02, 2008
STRYKER VISION ELECT WHDTV (STRYKER VE WHDTV)
K081995 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 80d
Cleared Oct 02, 2008
DYNAMATRIX
K082058 · NPL
Cook Biotech, Inc.
Dental · 73d
Cleared Oct 02, 2008
ADPHARMA OCCLUDE AND OCCLUDE F DENTIN TUBULE AGENT
K082071 · LBH
Adpharma, Inc.
Dental · 72d
Cleared Oct 02, 2008
ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)
K082106 · FMG
Elcam Medical Acal
General Hospital · 69d
Cleared Oct 02, 2008
BOVIE ICON GENERAL PURPOSE RF GENERATOR
K082109 · GEI
Bovie Medical
General & Plastic Surgery · 69d
Cleared Oct 02, 2008
VORICONAZOLE 1UG BBL SENSI-DISC
K082272 · JTN
Becton, Dickinson & CO
Microbiology · 52d
Cleared Oct 02, 2008
BARE PLATINUM FRAMING COIL, MODEL(S)...
K082461 · HCG
MicroVention, Inc.
Neurology · 36d
Cleared Oct 02, 2008
SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES
K082520 · BTR
Mallinckrodt Medical
Anesthesiology · 30d
Cleared Oct 02, 2008
AUTO-SAFETY INJECTOR-2 (ASI-2)
K082587 · KZH
Medical House Products Limited
General Hospital · 24d
Cleared Oct 01, 2008
LUMAPROBE
K073000 · GEX
Clareblend, Inc.
General & Plastic Surgery · 343d
Cleared Oct 01, 2008
CLAREBLEND LED PROBES MODEL# 7201-415, 7204-631, 7205-830
K073022 · GEX
Clareblend, Inc.
General & Plastic Surgery · 341d
Cleared Oct 01, 2008
SMARTSIGNS MINPULSE
K081572 · DQA
Huntleigh Healthcare , Ltd.
Anesthesiology · 119d