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
150673–150696 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 1984
SIGMA SUDAN BLACK REAGENT 380-1
K843684 · HZZ
Sigma Chemical Co.
Hematology · 43d
Cleared Oct 31, 1984
FLU VEN I.V. SET 0153-C PERMA-SET
K843692 · FPA
Venusa , Ltd.
General Hospital · 42d
Cleared Oct 31, 1984
JACOBS HIGH VACUUM SUCTION UNIT 05-2570
K843693 · BTA
J. Sklar Mfg. Co., Inc.
General & Plastic Surgery · 42d
Cleared Oct 31, 1984
MCGHAN TISSUE EXPANDER
K843704 · LCJ
Mcghan Medical Corp.
General & Plastic Surgery · 40d
Cleared Oct 31, 1984
RAICHEM X-HBDH REAGENT
K843774 · JMK
Reagents Applications, Inc.
Chemistry · 36d
Cleared Oct 31, 1984
TAL-CLIP
K843816 · GDJ
Talboy, Inc.
General & Plastic Surgery · 33d
Cleared Oct 31, 1984
ETHANOL CONTROLS LOW & HIGH E5133/E5258
K843872 · DKC
Sigma Chemical Co.
Chemistry · 29d
Cleared Oct 31, 1984
O.B. BASIN SET
K843982 · FRG
Pro-Lab, Inc.
General Hospital · 20d
Cleared Oct 31, 1984
AO-10 AUTOMATED OSMOMETER
K843997 · JJM
bioMerieux, Inc.
Chemistry · 20d
Cleared Oct 31, 1984
ONO/CO-TWO (TM) SYSTEMS
K844014 · JTY
Micro-Bio-Logics
Microbiology · 19d
Cleared Oct 31, 1984
STREP ID TRIPLATE
K844019 · JTO
Remel Co.
Microbiology · 16d
Cleared Oct 30, 1984
IMPEDANCE/8200 MONITOR-MODEL 8300
K840358 · KRC
Aequitron Medical, Inc.
Cardiovascular · 278d
Cleared Oct 30, 1984
MUSE-DP
K840932 · DXN
Marquette Electronics, Inc.
Cardiovascular · 242d
Cleared Oct 30, 1984
SCOTT SELECTICULT-HSV ISOLATION &
K841680 · GQL
Scott Laboratories, Inc.
Microbiology · 190d
Cleared Oct 30, 1984
ANTI-SCHISTOSOMA SPECIES KIT
K842660 · GNH
Amico Lab, Inc.
Immunology · 112d
Cleared Oct 30, 1984
EMA LIV CENERA DENTAL CEMENT
K842995 · EMA
Int'L Corp.
Dental · 92d
Cleared Oct 30, 1984
SERVO MED NYSTAGMOGRAPH NG-1
K843004 · GWN
Servo Med, Inc.
Neurology · 92d
Cleared Oct 30, 1984
ORAL THC-CANNABINOIDS DIRECT RIA KIT
K843534 · LAT
Immunalysis Corporation
Toxicology · 53d
Cleared Oct 30, 1984
DETECT-A-STREP
K843590 · GTZ
Antibodies, Inc.
Microbiology · 48d
Cleared Oct 30, 1984
RETIC-SET
K843619 · KQC
R&D Systems, Inc.
Hematology · 46d
Cleared Oct 30, 1984
PHOTOMETER 90IYS
K843668 · JJQ
Institute Virion , Ltd.
Microbiology · 43d
Cleared Oct 30, 1984
SIGMA PERIODIC ACID-SCHIFF STAIN 395
K843752 · HZT
Sigma Chemical Co.
Hematology · 35d
Cleared Oct 30, 1984
BETA QUIK V
K843795 · JHI
Pacific Biotech, Inc.
Chemistry · 33d
Cleared Oct 30, 1984
HUMAN SERUM ANTICONVULSANT DRUG CONTROL
K843818 · DIF
Quantimetrix Corp.
Toxicology · 32d