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
121825–121848 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 10, 1991
LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL
K911347 · JCM
Bio-Rad
Hematology · 75d
Cleared Jun 10, 1991
BAXTER MARATHON(TM) INTRAVASCULAR RELAY GUID CATH
K911367 · DQO
Baxter Healthcare Corp
Cardiovascular · 74d
Cleared Jun 10, 1991
EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST
K911569 · LLM
Ortho Diagnostic Systems, Inc.
Microbiology · 63d
Cleared Jun 10, 1991
EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TEST
K911570 · MCD
Ortho Diagnostic Systems, Inc.
Microbiology · 63d
Cleared Jun 10, 1991
EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST
K911571 · MCD
Ortho Diagnostic Systems, Inc.
Microbiology · 63d
Cleared Jun 10, 1991
DADE LIID-TROL TL TRI-LEVEL LIPID CONTROL
K911854 · JJY
Baxter Healthcare Corp
Chemistry · 45d
Cleared Jun 10, 1991
OSTEOMED IB DRILL
K911937 · EFB
Osteomed Corp.
Dental · 40d
Cleared Jun 10, 1991
IL PHOENIX(TM), MODEL 905 CHEM/ELECT ANALYZER
K912016 · JGS
Instrumentation Laboratory CO
Chemistry · 38d
Cleared Jun 10, 1991
SYVA EDMS
K912055 · JJF
Syva Co.
Chemistry · 32d
Cleared Jun 07, 1991
LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITS
K904440 · CAZ
Preferred Medical Products
Anesthesiology · 252d
Cleared Jun 07, 1991
NICOLET MAPLELEAF SYSTEM
K905632 · GWJ
Nicolet Instrument Corp.
Neurology · 172d
Cleared Jun 07, 1991
HYDROXYAPATITE COATED PROFILE(R) HIP STEM
K910156 · MEH
Depuy, Inc.
Orthopedic · 144d
Cleared Jun 07, 1991
VISTA HPQ SYSTEM
K910715 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 107d
Cleared Jun 07, 1991
503 PULSE OXIMETER
K911124 · DQA
Criticare Systems, Inc.
Anesthesiology · 87d
Cleared Jun 07, 1991
KODAK AUTOMATIC FILM FEEDER, MODEL RA
K911711 · IXW
Eastman Kodak Company
Radiology · 51d
Cleared Jun 07, 1991
KODAK 100-J & 100-K CHEMICAL MIXERS
K911713 · IXW
Eastman Kodak Company
Radiology · 51d
Cleared Jun 07, 1991
KODAK M35-MX-0MAT PROCESSOR
K911714 · IXW
Eastman Kodak Company
Radiology · 51d
Cleared Jun 07, 1991
OP-D-OP VISOR SHIELDS
K911742 · LYU
Op-D-Op, Inc.
General Hospital · 50d
Cleared Jun 07, 1991
COMPULSE CO2 SURGICAL LASER SYS.
K911852 · GEX
Laser Engineering, Inc.
General & Plastic Surgery · 42d
Cleared Jun 07, 1991
DEGULUX LIGHT CURING UNIT
K912037 · EBF
Degussa AG
Dental · 30d
Cleared Jun 07, 1991
ISOTECHNOLOGIES LIFTSTATION & LIFTWORKS SOFTWARE
K912175 · INK
Isotechnologies, Inc.
Physical Medicine · 22d
Cleared Jun 07, 1991
PHILIPS M30 IN-THE-EAR HEARING AID
K912339 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 14d
Cleared Jun 06, 1991
MENSOR COMPLIANT KEEPER
K885158 · DZE
Merrill C. Mensor, Jr., D.D.S.
Dental · 905d
Cleared Jun 06, 1991
VITAPATCH PIN PROTECTION DEVICE FOR PERCUTANEOUS
K895920 · KGX
Vitaphore Corp.
General & Plastic Surgery · 603d