FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
168001–168024 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 1979
MODEL DM 353 & DM-353-L SINGLE NEEDLE
K792174 · FIF
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 18d
Cleared Nov 16, 1979
DEODORANT CAREFREE PANTY SHIELDS
K792195 · HHL
Personal Products Co.
Obstetrics & Gynecology · 15d
Cleared Nov 16, 1979
SPECIMAN CUP & EMESIS BASIN
K792211 · FMH
General Clinical Plastics Corp.
General Hospital · 14d
Cleared Nov 15, 1979
BIOBRANE BRAND TEMPORARY WOUND DRESSING
K791184
Hall-Woodroof, Inc.
General & Plastic Surgery · 143d
Cleared Nov 15, 1979
MEDTRONIC MODELS 5984/5985
K791316 · DXY
Medtronic Vascular
Cardiovascular · 126d
Cleared Nov 15, 1979
CARDIO CK-B RIA KIT
K791582 · JHX
Nuclear Medical Systems, Inc.
Chemistry · 92d
Cleared Nov 15, 1979
PAP RIA KIT
K791735 · JFH
Nuclear Medical Systems, Inc.
Chemistry · 77d
Cleared Nov 15, 1979
AEROBITRON II
K792120 · ISD
Stanford Scientific, Inc.
Physical Medicine · 21d
Cleared Nov 15, 1979
AEROBITRON III
K792121 · ISD
Stanford Scientific, Inc.
Physical Medicine · 21d
Cleared Nov 15, 1979
ADJUSTABLE TUBE TREE FOR ANESTH. HOSES
K792148 · JAY
Medical Innovations Corp.
Anesthesiology · 24d
Cleared Nov 15, 1979
MILLAR MIKRO-TIP CATHETER TRANSDUCER
K792177 · DXO
Millar Instruments, Inc.
Cardiovascular · 16d
Cleared Nov 15, 1979
3M HS 22 FEMORAL COMPONENT
K792181 · KWL
3M Company
Orthopedic · 17d
Cleared Nov 15, 1979
ICE CONTAINER I.C.E.
K792182 · IME
Delta Medical Industries
Physical Medicine · 17d
Cleared Nov 13, 1979
DELTA D-750 THERMAFLOW
K790406 · DTZ
Delta Medical Industries
Cardiovascular · 260d
Cleared Nov 13, 1979
CENTRIA VITAMIN B12 FOLATE RADIO SET
K791216 · CDD
Ventrex Laboratories, Inc.
Chemistry · 134d
Cleared Nov 13, 1979
BATTERY POWERED SYRINGE INFUSION PUMP
K791293 · FRN
Harvard Apparatus, Inc.
General Hospital · 126d
Cleared Nov 13, 1979
COAXIAL DUAL FLOW CATHETER
K791411 · KOC
Terumo America, Inc.
Gastroenterology & Urology · 109d
Cleared Nov 13, 1979
MODEL AS* 6C INFUSION PUMP
K791566 · FRW
Baxter Healthcare Corp
General Hospital · 95d
Cleared Nov 13, 1979
RUBELLA BIO-BEAD SCREEN KIT
K791610 · GOL
Litton Bionetics
Microbiology · 84d
Cleared Nov 13, 1979
TOXO BIO-BEAD SCREEN KIT
K791611 · GLZ
Litton Bionetics
Microbiology · 84d
Cleared Nov 13, 1979
CMV BIO-BEAD SCREEN KIT
K791612 · GQH
Litton Bionetics
Microbiology · 84d
Cleared Nov 13, 1979
HSV BIO-BEAD SCREEN KIT
K791614 · GQN
Litton Bionetics
Microbiology · 84d
Cleared Nov 13, 1979
TORCH BIO-BEAD SCREEN KIT
K791618 · GLZ
Litton Bionetics
Microbiology · 85d
Cleared Nov 13, 1979
COMPU-SCAN
K791632 · DSI
Hittman Medical Systems
Cardiovascular · 84d