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
152425–152448 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 01, 1984
DIA FIBRIN
K841366 · KQJ
Diatech, Inc.
Hematology · 60d
Cleared Jun 01, 1984
HEPARIN COAGULATION CONTROL PLASMA 1-
K841462 · JPA
Diatech, Inc.
Hematology · 53d
Cleared Jun 01, 1984
OWREN'S VERONAL BUFFERR
K841523 · JPA
Diatech, Inc.
Hematology · 50d
Cleared Jun 01, 1984
SERUM COMPLEMENT ACTIVITY TEST-SCAT
K841541 · DAK
Collaborative Research, Inc.
Immunology · 46d
Cleared Jun 01, 1984
VAST VENTREX RAST ALL
K841651 · DGC
Ventrex Laboratories, Inc.
Immunology · 42d
Cleared Jun 01, 1984
OCULAR PRESSURE APPLICATOR
K841652
The Lebanon Corp.
Ophthalmic · 42d
Cleared Jun 01, 1984
ACCUPRO ENTERAL FEEDING PUMP
K841729 · FRN
American Mcgaw
General Hospital · 37d
Cleared Jun 01, 1984
TAGO FIFFU-GEN, OROSOMUCOID
K841734 · LKL
Tago, Inc.
Immunology · 36d
Cleared Jun 01, 1984
OPHTHALMIC TABLE
K841759 · HMG
Woodlyn, Inc.
Ophthalmic · 35d
Cleared Jun 01, 1984
WOODLYN CLASSIC TRIAL LENS SET
K841766 · HPC
Woodlyn, Inc.
Ophthalmic · 35d
Cleared Jun 01, 1984
WOODLYN LIGHTWEIGHT TRIAL FRAME
K841768 · HPA
Woodlyn, Inc.
Ophthalmic · 35d
Cleared Jun 01, 1984
OPTIMATE IGA TEST
K841815 · CZN
Miles Laboratories, Inc.
Immunology · 31d
Cleared Jun 01, 1984
MICROSURGICAL KNIFE
K841951 · HNN
Ethicon, Inc.
Ophthalmic · 18d
Cleared Jun 01, 1984
BIPHASIC BLOOD CULTURE BOTTLE
K842036 · JSG
Gibco Laboratories Life Technologies,...
Microbiology · 11d
Cleared Jun 01, 1984
TITERTEK-ENTEROBAC RAPID AUTOMATED
K842182
Flow Laboratories, Inc.
Microbiology
Cleared May 31, 1984
SUTURE REMOVAL KITS STERILE
K833688 · KGX
Carwild Corp.
General & Plastic Surgery · 213d
Cleared May 31, 1984
VARIOUS DISPOSABLE KITS/TRAYS/INSTRU
K840976 · FSM
Carapace, Inc.
General & Plastic Surgery · 86d
Cleared May 31, 1984
MORWEL ASPIRATOR
K841160 · JCX
Morwel Corp.
General & Plastic Surgery · 73d
Cleared May 31, 1984
ACME DIGITAL INFANT SCALE-30
K841534 · FRW
Acme Medical Scale Co.
General Hospital · 45d
Cleared May 31, 1984
IMPACT MODEL 601
K841537 · BTI
Impact Instrumentation, Inc.
Anesthesiology · 45d
Cleared May 31, 1984
CHOCOLATE AGAR
K841586 · KZI
Microline Scientific
Microbiology · 44d
Cleared May 31, 1984
HEALTHCHECK HOME PREGNANCY TEST KIT
K841595 · LCX
Timex Medical Products Corp.
Chemistry · 43d
Cleared May 31, 1984
TDX REA URIC ACID
K841702 · KNK
Abbott Laboratories
Chemistry · 38d
Cleared May 31, 1984
KYOTEST UG URINE TEST REAGENT STRIP
K841713 · JIL
Kyoto Diagnostics, Inc.
Chemistry · 37d