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
173281–173304 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 08, 1977
MONITOR, PATIENT, MODEL PM-I0N
K770968 · CCK
Cavitron Corp.
Anesthesiology · 8d
Cleared Jun 08, 1977
ANTI-CONVULSANT DRUG CONTROL
K770975 · DIC
Lederle Laboratories
Toxicology · 8d
Cleared Jun 07, 1977
BAND-AID BRAND ADHES. BAND.-SHEER STRIPS
K770533 · FPX
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 78d
Cleared Jun 03, 1977
URINE TESTER, MODEL NO. 707
K770423 · EXR
Brother Scientific Products, Inc.
Chemistry · 88d
Cleared Jun 03, 1977
REAGENT SYSTEM 153-UV
K770519 · JKG
Sigma Chemical Co.
Chemistry · 77d
Cleared Jun 03, 1977
RADIOIMMUNOASSAY, QUANTITIPE 125-I-T3
K770520 · CDP
Kallestad Laboratories, Inc.
Chemistry · 77d
Cleared Jun 03, 1977
CPK ISOENZYME CONTROL
K770555 · JJT
Bio-Reagents & Diagnostics, Inc.
Chemistry · 74d
Cleared Jun 03, 1977
URIC ACID TEST KIT
K770564 · CDH
Mallinckrodt Critical Care
Chemistry · 71d
Cleared Jun 03, 1977
HEMATRAK MODEL 125
K770701 · GKZ
Geometric Data, Div. Smithkline Corp.
Hematology · 46d
Cleared Jun 03, 1977
TYGON PAC-MONITORING LINES & FLUID ADMIN
K770707 · FMG
Norton Performance Plastics Corp.
General Hospital · 46d
Cleared Jun 03, 1977
PORTASCOPE II
K770832 · DPS
Mennen Greatbatch Electonics
Cardiovascular · 28d
Cleared Jun 03, 1977
RABBIT COMPLEMENT
K770866 · DHL
Cedarlake Labs , Ltd.
Immunology · 23d
Cleared Jun 03, 1977
IMPROVED THAYER MARTIN (JEMBEC)
K770875 · JTY
Granite Diagnostics, Inc.
Microbiology · 18d
Cleared Jun 03, 1977
IMPROVED TRANSGROW
K770876 · JTY
Granite Diagnostics, Inc.
Microbiology · 18d
Cleared Jun 03, 1977
POMERANTZEFF EQUATOR PLUS CAMERA
K770888 · HKI
Medical Instrument Research Assoc., Inc.
Ophthalmic · 18d
Cleared Jun 03, 1977
COLPOSCOPE MODEL II
K770896 · HEX
Dynatech Cryomedical Co.
Obstetrics & Gynecology · 18d
Cleared Jun 03, 1977
URODYNAMIC INSTRUMENTS
K770897 · EXY
Life-Tech Instruments, Inc.
Gastroenterology & Urology · 18d
Cleared Jun 03, 1977
APPLIC SYSTEM APPLIER, ESPE
K770931 · EID
Espe GmbH (Us)
Dental · 11d
Cleared Jun 03, 1977
GERAMCO LOW TEMP GLAZE
K770932 · EIH
Johnson & Johnson Professionals, Inc.
Dental · 11d
Cleared Jun 03, 1977
URINE TESTER, MODEL 701
K770939 · EXR
Brother Scientific Products, Inc.
Gastroenterology & Urology · 11d
Cleared Jun 02, 1977
TECHNICON SMA & AAII SYSTEMS
K770406 · CJE
Boehringer Laboratories
Chemistry · 91d
Cleared Jun 02, 1977
CENTRIFI CHEM CALCIUM REAGENT
K770460 · CIC
Union Carbide Corp.
Chemistry · 86d
Cleared Jun 02, 1977
RIA-120 AND ESTRIOL REAGENT SYSTEM
K770465 · CGI
Bd Becton Dickinson Vacutainer...
Chemistry · 84d
Cleared Jun 02, 1977
WORTHINGTON BUN
K770470 · CDW
Worthington Biochemical Corp.
Chemistry · 84d