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
156889–156912 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 05, 1983
URINARY DIVERSION STENT
K830803 · LJE
Van-Tec, Inc.
Gastroenterology & Urology · 52d
Cleared May 05, 1983
LA-HISTO ANTIBODY SYSTEM #HL 1001
K830837 · GMJ
Immuno-Mycologics, Inc.
Microbiology · 50d
Cleared May 05, 1983
HELENA BIOSTRIP PH
K830979 · CEN
Helena Laboratories
Chemistry · 37d
Cleared May 05, 1983
DIAGNOSTICS PO2 ELECTRODE CLEANER
K831010 · CHL
Fisher Scientific Co., LLC
Chemistry · 36d
Cleared May 05, 1983
BATH CLEAR
K831016 · CHL
Fisher Scientific Co., LLC
Chemistry · 36d
Cleared May 05, 1983
API ANAIDENT
K831032 · JSP
Analytical Products, Inc.
Microbiology · 36d
Cleared May 05, 1983
BTC URINE LCG ASSAY
K831125 · JHJ
Btc Diagnostics, Inc.
Immunology · 30d
Cleared May 04, 1983
CULUTURE SET CHLAMYDIA ISOLATION AND
K830342 · LKI
Immulok, Inc.
Microbiology · 92d
Cleared May 04, 1983
BOO-BOO STRIP
K830640 · FRO
Colossus Corp.
General & Plastic Surgery · 64d
Cleared May 04, 1983
LABILE REMOVING HEMOLYZING REAGENT
K830804 · JBD
Corning Medical & Scientific
Hematology · 51d
Cleared May 04, 1983
FLOW-PAC SGOT REAGENT
K830958 · CIT
Amresco, Inc.
Chemistry · 40d
Cleared May 04, 1983
FLOW-PAC SGPT REAGENT
K830959 · CKA
Amresco, Inc.
Chemistry · 40d
Cleared May 04, 1983
IMMUCHEM COVALENT-COAT RIA KIT
K830962 · DPO
Immuchem Corp.
Chemistry · 37d
Cleared May 04, 1983
ANAEROBE MIC/ID TEMPLATE, & TAXONOMY
K830964 · JSP
Bd Becton Dickinson Vacutainer...
Microbiology · 37d
Cleared May 04, 1983
PLAN A LIFE
K830975 · JIN
New Directions Co.
Chemistry · 40d
Cleared May 04, 1983
HELENA BIOSTRIP K
K830976 · JIN
Helena Laboratories
Chemistry · 36d
Cleared May 04, 1983
MEDICA IIF-MULTIPLE ANTIBODY TEST KIT
K831100 · DBM
Medical Diagnostics, Ca.
Immunology · 29d
Cleared May 03, 1983
TEMP-CHECK ADAPTOR, STRAIGHT CONFIGURA
K830923 · BZO
Cygnus Research Corp.
Anesthesiology · 42d
Cleared May 03, 1983
OXYGEN CONNECTING TUBE
K830988 · BYX
Medovations, Inc.
Anesthesiology · 35d
Cleared May 03, 1983
AMPLIGREFFE
K830993 · GFD
Prothia USA, Inc.
General & Plastic Surgery · 35d
Cleared May 03, 1983
PERSONAL KNEE CRUTCH PAD
K831149 · INP
Tecnol New Jersey Wound Care, Inc.
Physical Medicine · 25d
Cleared May 03, 1983
LO-COMP RESERVOIR-RE-1000
K831163 · BTT
Cygnus Research Corp.
Anesthesiology · 22d
Cleared May 03, 1983
DUSTCOVERS/STERILITY MAINTENANCE COVERS
K831165 · KCT
Medical Industries Packaging, Inc.
General Hospital · 22d
Cleared May 02, 1983
BBL STREP GROUPING KIT
K830510 · GCY
Bd Becton Dickinson Vacutainer...
General & Plastic Surgery · 73d