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
151921–151944 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 1984
NEW JERSEY FEMORAL STEM
K842234 · KWL
Endomedics, Inc.
Orthopedic · 45d
Cleared Jul 20, 1984
CEFONICID 30 MCG SENSI-DISC
K842252 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 43d
Cleared Jul 20, 1984
VACUPULSE VACUUM UNIT
K842268 · IPF
I-Rep, Inc.
Physical Medicine · 42d
Cleared Jul 20, 1984
ELECTRODE, SURFACE EEG ELECTRODE
K842271 · GXY
Durden Enterprises, Inc.
Neurology · 42d
Cleared Jul 20, 1984
BECTEC NR-660 BACTERIAL DETECT SYS
K842279 · JTA
Bd Becton Dickinson Vacutainer...
Microbiology · 42d
Cleared Jul 20, 1984
GENERAL DIAG. CEFONICID 30MCG ANTIMIC
K842307 · JTN
General Diagnostics
Microbiology · 38d
Cleared Jul 20, 1984
CRITIKON TRIPLE-LUMEN CENTRAL VENOUS
K842316 · DQY
Critikon Company, LLC
Cardiovascular · 38d
Cleared Jul 20, 1984
SICKLE CELL REAGENT SET
K842368 · GHM
Livonia Diagnostics, Inc.
Hematology · 35d
Cleared Jul 20, 1984
LACTATE DEHYDROGENASE ASSAY KIT
K842507 · CFJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 24d
Cleared Jul 20, 1984
CREATINE KINASE ASSAY KIT NAC
K842508 · CGS
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 24d
Cleared Jul 20, 1984
CALCIUM ASSAY KIT
K842509 · CIC
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 24d
Cleared Jul 20, 1984
GLUCOSE ASSAY KIT-HEXOKINASE
K842510 · CFR
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 24d
Cleared Jul 20, 1984
CHESEBROUGH-POND'S REUSABLE URINARY LEG
K842553 · KNX
Chesebrough-Pond'S U.S.A. Co.
Gastroenterology & Urology · 18d
Cleared Jul 20, 1984
GNC PLUS
K842587 · JTO
Vitek Systems, Inc.
Microbiology · 17d
Cleared Jul 20, 1984
EMERSON MOTION BED 6-MS & 6-ME
K842604 · IKZ
J. H. Emerson Co.
Physical Medicine · 15d
Cleared Jul 20, 1984
CA2000
K842611 · IKN
Nicolet Biomedical Instruments
Neurology · 15d
Cleared Jul 20, 1984
COMPACT AUDITORY
K842612 · IKN
Nicolet Biomedical Instruments
Neurology · 15d
Cleared Jul 20, 1984
COMPACT VISUAL
K842613 · IKN
Nicolet Biomedical Instruments
Neurology · 15d
Cleared Jul 20, 1984
BASAL MED. EAGLE B8265, W/EARLS SALTS
K842671 · KIT
Sigma Chemical Co.
Pathology · 10d
Cleared Jul 20, 1984
MINIMUM ESSENTIAL MED. M0769 W/WO
K842672 · KIT
Sigma Chemical Co.
Pathology · 10d
Cleared Jul 19, 1984
ASTRON 77 INJECTION DENTURE RESIN
K833270 · EBI
Astron Dental Corp.
Dental · 302d
Cleared Jul 19, 1984
CODE 17-ENDOSCOPE DEODORANT
K840208 · FEB
Knox Laboratories
General Hospital · 182d
Cleared Jul 19, 1984
DANAM ELEC. SA-1000
K840649 · GKL
Danam Electronics
Hematology · 155d
Cleared Jul 19, 1984
OLYMPUS KC-10 MOBILE DISINFEC-STAT
K841331 · NZA
Keymed, Inc.
General Hospital · 108d