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

Filters: Cleared only ×
176,076 results
77113–77136 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 20, 2002
BABYCOM
K013547 · KNG
Pmg Medica , Ltd.
Radiology · 119d
Cleared Feb 20, 2002
NEUROSENSOR
K013930 · GWM
Novus Monitoring, Ltd.
Neurology · 84d
Cleared Feb 20, 2002
UNIFIL BOND
K013997 · KLE
GC America, Inc.
Dental · 78d
Cleared Feb 20, 2002
COMPLETE BRAND MULTI-PURPOSE SOLUTION
K014202 · LPN
Allergan, Inc.
Ophthalmic · 61d
Cleared Feb 20, 2002
SYNTHES CRANIAL PLATES
K020087 · JEY
Synthes (Usa)
Dental · 41d
Cleared Feb 20, 2002
VASOVIEW 5 HARVESTING CANNULA
K020143 · HET
Guidant Corporation, Cardiac Surgery
Obstetrics & Gynecology · 35d
Cleared Feb 19, 2002
PROTOCO2L INSUFFLATOR MODEL 6400
K013219 · FCX
E-Z-Em, Inc.
Gastroenterology & Urology · 146d
Cleared Feb 19, 2002
CRYSTAL MONITOR MODEL 16
K013863 · OMC
Cleveland Medical Devices, Inc.
Neurology · 90d
Cleared Feb 19, 2002
CLEARPLANE EASY OVULATION TEST
K013874 · CEP
Unipath , Ltd.
Chemistry · 90d
Cleared Feb 19, 2002
PRIME-DENT HEMA DESENSITIZER
K013970 · EBF
Prime Dental Manufacturing, Inc.
Dental · 78d
Cleared Feb 19, 2002
LIBERTY BLOOD GLUCOSE MONITORING SYSTEM
K014167 · NBW
Polymedica Pharmaceuticals, U.S.A.,...
Chemistry · 62d
Cleared Feb 19, 2002
MEDSURG EQUIPMENT COVERS
K014239 · MMP
International Medsurg Connection
General Hospital · 55d
Cleared Feb 19, 2002
JETPOLISHER
K014249 · KOJ
Deldent , Ltd.
Dental · 55d
Cleared Feb 19, 2002
JETSTREAM
K014252 · KOJ
Deldent , Ltd.
Dental · 55d
Cleared Feb 19, 2002
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K014258 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 55d
Cleared Feb 19, 2002
K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET
K014293 · DBF
Kamiya Biomedical Co.
Immunology · 53d
Cleared Feb 19, 2002
BONART ART-E1 ELECTROSURGERY UNIT
K020080 · EKZ
Diagnostic Data, Inc.
Dental · 41d
Cleared Feb 19, 2002
SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTER
K020277 · DRQ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 22d
Cleared Feb 19, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEFUROXIME (1-64...
K020328 · LON
Dade Behring, Inc.
Microbiology · 19d
Cleared Feb 15, 2002
CAVITAT ULTRASOUND BONE DENSITOMETER (CAVITAT)
K011147 · EHD
Cavitat Medical Technologies, Inc.
Radiology · 305d
Cleared Feb 15, 2002
MB 103 MILLENNIUM BLADES
K011833 · HNO
Millennium Biomedical, Inc.
Ophthalmic · 248d
Cleared Feb 15, 2002
VCS-A SERIES CLAMP
K011863 · DXC
Vascular Control Systems, Inc.
Radiology · 246d
Cleared Feb 15, 2002
A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE...
K012472 · DXN
A&D Engineering, Inc.
Cardiovascular · 197d
Cleared Feb 15, 2002
ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY
K013276 · EZL
Sewoon Medical Co., Ltd.
Gastroenterology & Urology · 137d