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
163537–163560 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 13, 1981
PHADEBAS ISOAMYLASE TEST
K810584 · CIW
Pharmacia, Inc.
Chemistry · 70d
Cleared May 13, 1981
K-MED ENCOURAGER INCENTIVE SPIROMETER
K810641 · BWF
K-Med, Inc.
Anesthesiology · 64d
Cleared May 13, 1981
MINIMUM ESSENTIAL MEDIUM EAGLE W/HANKS
K810768 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
MINIMUM ESSENTIAL MEDIUM EAGLE W/EARLE
K810769 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
MED. 199(MODIFIED) W/HANKS' SALTS
K810770 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
L-15 MEDIUM (MODIFIED)
K810771 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
MEDIUM 199 W/EARLE'S SALTS & GLUTAMINE
K810772 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
BASAL MEDIUM EAGLE W/HANKS' SALTS
K810773 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
WATER-TISSUE CULTURE GRADE
K810774 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
PENICILLIN-STREPTOMYCIN MIXTURE
K810776 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
BASAL MEDIUM EAGLE (MOD.) W/EARLE'S SALT
K810778 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
EARLE'S BALANCED SALTS SOULTION
K810779 · KIP
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
SODIUM BICARBONATE (7.5%) SOLUTION
K810780 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
L-GLUTAMINE
K810781 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
TRYPAN BLUE (0.5% IN NORMAL SALINE)
K810782 · LGY
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
ALSEVER'S SOLUTION (MODIFIED)
K810783 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
XIMATRON V
K810858 · KPQ
Siemens Corp.
Radiology · 44d
Cleared May 13, 1981
ARALUEN HEAD SHIELD
K810868 · FPP
Araluen, Inc.
General Hospital · 43d
Cleared May 13, 1981
ESOPHAGEAL PILL ELECTRODE
K810895 · DRX
Con Med Equipment, Inc.
Cardiovascular · 40d
Cleared May 13, 1981
GAMMA CAMERA
K810974 · IYX
Siemens Gammasonics, Inc.
Radiology · 33d
Cleared May 13, 1981
ENDODONTIC POST SYSTEMS
K810977 · ECG
Preat Corp.
Dental · 33d
Cleared May 13, 1981
SHILEY LOW PRESSURE THIN-CUFFED TRACH
K811033 · BTO
Shiley, Inc.
Anesthesiology · 28d
Cleared May 13, 1981
BALANCE ARTICULATOR
K811075 · EJP
Almore Intl., Inc.
Dental · 23d
Cleared May 13, 1981
HCG RADIOIMMUNOASSAY
K811116 · JHI
Hoffmann-La Roche, Inc.
Chemistry · 19d