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
162937–162960 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 1981
ASSURE NATURAL FIT TAMPON
K811992 · HEB
Personal Products Co.
Obstetrics & Gynecology · 7d
Cleared Jul 16, 1981
DOPPLEX-PLB & PXB
K810115 · KNG
Huntleigh Technology, Inc.
Radiology · 181d
Cleared Jul 16, 1981
CONTACT-MICRO COLPOHYSTEROSCOPE
K810569 · HIH
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 135d
Cleared Jul 16, 1981
THE BETA
K810940 · DSI
Burdick Corp.
Cardiovascular · 100d
Cleared Jul 16, 1981
THROMBIN CLOTTING TIME
K811109 · GJA
Bio/Data Corp.
Hematology · 84d
Cleared Jul 16, 1981
EYE CARE TRAY
K811117
American Pharmaseal Div. Ahsc
Ophthalmic · 83d
Cleared Jul 16, 1981
BIOVISION CARDIAC STROBE
K811341 · DPS
Cardiac Imaging
Cardiovascular · 65d
Cleared Jul 16, 1981
TOXOPLASMOSIS TEST KIT
K811562 · GLZ
Immuno-Diagnostic Products, Inc.
Microbiology · 43d
Cleared Jul 16, 1981
CERVICAL DILATOR
K811568 · HDQ
Gynemetrics, Inc.
Obstetrics & Gynecology · 42d
Cleared Jul 16, 1981
ACTIN FS ACTIVATED PTT REAGENT
K811589 · GGW
American Dade
Hematology · 38d
Cleared Jul 16, 1981
PLAYTEX MODIFIED FIBER TAMPONS
K811660 · HIL
Playtex, Inc.
Obstetrics & Gynecology · 34d
Cleared Jul 16, 1981
MODEL 381 HOME OXYGEN SENTRY
K811702 · CCL
Stanley Aviation Corp.
Anesthesiology · 30d
Cleared Jul 16, 1981
H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME
K811721 · DFH
Immulok, Inc.
Pathology · 28d
Cleared Jul 16, 1981
KALLESTAD'S ENDOPLATE FACTOR B TEST
K811740 · JZH
Kallestad Laboratories, Inc.
Immunology · 27d
Cleared Jul 16, 1981
MAXITHERM
K811743 · DWJ
Cincinnati Sub-Zero
Cardiovascular · 27d
Cleared Jul 16, 1981
REDUCT-ASE TUBES
K811852 · JSH
Microchemical Specialities, Co.
Microbiology · 15d
Cleared Jul 16, 1981
PHOLPHORYL-ASE TUBES
K811853 · JTO
Microchemical Specialities, Co.
Microbiology · 15d
Cleared Jul 16, 1981
GALACTOSID-ASE TUBES
K811854 · JTO
Microchemical Specialities, Co.
Microbiology · 15d
Cleared Jul 16, 1981
KHI CPRAM BREATHING CIRCUIT
K811858 · CAI
Khi, Inc.
Anesthesiology · 15d
Cleared Jul 16, 1981
EASY-FLO ARTERIAL BLOOD GAS KIT
K811860 · CBT
Dhd Medical Products Div. Diemolding...
Anesthesiology · 15d
Cleared Jul 16, 1981
ARTHROSCOPIC LEG HOLDER
K811861 · HRX
Stryker Corp.
Orthopedic · 15d
Cleared Jul 16, 1981
SCENTED MENSTRUAL PADS
K811868 · HHL
Procter & Gamble Mfg. Co.
Obstetrics & Gynecology · 15d
Cleared Jul 16, 1981
UNSCENTED MENSTRUAL PADS
K811869 · HHD
Procter & Gamble Mfg. Co.
Obstetrics & Gynecology · 15d
Cleared Jul 16, 1981
LEECO FERRITIN-QUANT DIAG. TEST KIT
K811880 · DBF
Leeco Diagnostics, Inc.
Immunology · 15d