FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
121561–121584 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 1991
OMNIFIT II EPF HIP STEM SERIES
K911585 · MEH
Osteonics Corp.
Orthopedic · 83d
Cleared Jul 01, 1991
MONOPOLAR POLLYPECTOMY SNARE
K911700 · KNS
Everest Medical Corp.
Gastroenterology & Urology · 76d
Cleared Jul 01, 1991
ARD(TM) ANTIMICROBIAL REMOVAL DEVICE
K911771 · LJK
Bd Becton Dickinson Vacutainer...
Microbiology · 73d
Cleared Jul 01, 1991
KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON
K911801 · JIN
Gds Technology, LLC
Chemistry · 69d
Cleared Jul 01, 1991
OPUS(R) TOBRAMYCIN
K911940 · LCR
Pb Diagnostic Systems, Inc.
Toxicology · 61d
Cleared Jul 01, 1991
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
K912217 · DIH
Eastman Kodak Company
Chemistry · 42d
Cleared Jul 01, 1991
KETO-340 II
K912373 · JIN
Ihara Medics U.S., Inc.
Chemistry · 33d
Cleared Jul 01, 1991
I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK
K912387 · JGS
I-Stat Corp.
Chemistry · 61d
Cleared Jul 01, 1991
CHEM-LINK DATA BASE MANAGER
K912413 · JJQ
Technicon Instruments Corp.
Chemistry · 31d
Cleared Jul 01, 1991
AMYLASE REAGENT
K912519 · JFJ
Genzyme Corp.
Chemistry · 25d
Cleared Jul 01, 1991
IMX HCG
K912534 · JHI
Abbott Laboratories
Chemistry · 24d
Cleared Jul 01, 1991
IMX TOTAL B-HCG
K912535 · JHI
Abbott Laboratories
Chemistry · 24d
Cleared Jul 01, 1991
NOVA 1 SODIUM/POTASSIUM/HEMATOCRIT ANALYZER
K912559 · JGS
Nova Biomedical Corp.
Chemistry · 20d
Cleared Jun 28, 1991
LYME DISEASE IGM ELISA
K900206 · LSR
Hillcrest Biologicals
Microbiology · 528d
Cleared Jun 28, 1991
ADVANCE SUTURE NONABSORBABLE POLYPROPYLENE SUTURE
K903176 · GAW
Advance Suture, Inc.
General & Plastic Surgery · 345d
Cleared Jun 28, 1991
ADVANCE SUTURE NONABSORBABLE NYLON SUTURE
K903177 · GAR
Advance Suture, Inc.
General & Plastic Surgery · 345d
Cleared Jun 28, 1991
EYEOPENER
K904469 · JYJ
Kc Medical Industries
Ear, Nose, Throat · 270d
Cleared Jun 28, 1991
UNIVERSAL COMPRESSION SCREW
K904809 · HWC
Howmedica Corp.
Orthopedic · 247d
Cleared Jun 28, 1991
EXTEND TRACK UNIT
K904963 · BXB
Anthony Chiropractic Clinic, Inc.
Physical Medicine · 235d
Cleared Jun 28, 1991
ADVANCE SUTURE NONABSORBABLE SILK SUTURE
K905454 · GAP
Advance Suture, Inc.
General & Plastic Surgery · 205d
Cleared Jun 28, 1991
STAINING SYSTEM FOR PNEUMOCYSTIS CARINII
K905504 · LYF
Dako Corp.
Microbiology · 203d
Cleared Jun 28, 1991
NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300
K905594 · GWK
Nihon Kohden America, Inc.
Neurology · 197d
Cleared Jun 28, 1991
SUH VENT TUBE
K910618 · ETD
Boston Medical Products, Inc.
Ear, Nose, Throat · 136d
Cleared Jun 28, 1991
COOK TISSUE MORCELLATOR
K910939 · GEI
Cook Urological, Inc.
General & Plastic Surgery · 114d