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
154585–154608 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 1983
CARDIOTOMY RESERVOIR-FILTER 050-108-050
K832671 · DTN
Cobe Laboratories, Inc.
Cardiovascular · 140d
Cleared Dec 27, 1983
RMP INTUBATION EQUIP. STORAGE TRAY
K832697 · BZN
Rmp Co.
Anesthesiology · 139d
Cleared Dec 27, 1983
MUMPS COMPLEMENT FIXATION & HEMAGGLU
K832873 · GRC
Hazleton Dutchland, Inc.
Immunology · 124d
Cleared Dec 27, 1983
EBV-VCA-IGM IFA TEST SYSTEM
K833014 · LJN
Zeus Scientific, Inc.
Immunology · 112d
Cleared Dec 27, 1983
ALPHA Y-RECIPIENT SET
K833294 · BRZ
Alpha Therapeutic Corp.
General Hospital · 95d
Cleared Dec 27, 1983
BRONCHOSCOPY TUBE W/ULTRA LOCUFF
K833297 · BTS
Surgitek
Anesthesiology · 95d
Cleared Dec 27, 1983
DUOFLO 6F
K833303 · DQY
Argon Medical Corp.
Cardiovascular · 95d
Cleared Dec 27, 1983
PHADEBACK G.C. POSITIVE CONTROLS
K833307 · JSX
Pharmacia, Inc.
Microbiology · 95d
Cleared Dec 27, 1983
DUAL LUMEN NEEDLE
K833308 · KOC
Quinton, Inc.
Gastroenterology & Urology · 92d
Cleared Dec 27, 1983
N-ACETYLPROCAINAMIDE ACA-ANALYTICAL
K833378 · LAN
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 89d
Cleared Dec 27, 1983
LIDOCAINE ANALYTICAL TEST PACK ACA
K833379 · KLR
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 89d
Cleared Dec 27, 1983
LIDOAINE CALIBRATOR
K833380 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 89d
Cleared Dec 27, 1983
VALPROIC ACID ANALYTICAL TEST PACK
K833381 · KLR
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 89d
Cleared Dec 27, 1983
VALPROIC ACID CALIBRATOR
K833382 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 89d
Cleared Dec 27, 1983
PROCAINAMIDE CALIBRATOR
K833383 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 89d
Cleared Dec 27, 1983
PROCAINAMIDE ANALYTICAL TEST PACK
K833384 · LAR
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 89d
Cleared Dec 27, 1983
HS4 HEAD/NECK FEMORAL PROSTHESES
K833461
Osteonics Corp.
Orthopedic · 83d
Cleared Dec 27, 1983
BDH UNIVERSAL HIP SYSTEM SURGEON
K833468 · JDG
Carbomedics, Inc.
Orthopedic · 82d
Cleared Dec 27, 1983
DENTIN BONDING AGENT
K833473 · KLE
Johnson & Johnson Professionals, Inc.
Dental · 82d
Cleared Dec 27, 1983
VIRALIZER NEBULIZER SPRAYER
K833474 · CCQ
Viral Response System, Inc.
Anesthesiology · 82d
Cleared Dec 27, 1983
INTERSEPT 40 MICRON FILTER W/TUBING
K833476 · DTM
Extracorporeal Medical Specialities,...
Cardiovascular · 81d
Cleared Dec 27, 1983
INTERSEPT 40 MICRON FILTER
K833477 · DTM
Extracorporeal Medical Specialities,...
Cardiovascular · 81d
Cleared Dec 27, 1983
PARTIAL DENTURE ALLOY
K833512 · EJH
Dentsply Intl.
Dental · 77d
Cleared Dec 27, 1983
COMFEEL CLEANSER
K833566 · EXB
Coloplast A/S
Gastroenterology & Urology · 76d