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
147313–147336 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 31, 1985
PORCELAIN VENEER SYSTEM LABORATORY KIT
K852743 · EIH
The S. S. White Co.
Dental · 34d
Cleared Jul 31, 1985
TELEDYNE GETZ BARRIER-DENTIN SEALER
K852756 · LBH
Scientific Pharmaceuticals, Inc.
Dental · 33d
Cleared Jul 31, 1985
A-COMPANY SELF-LIGATING APPLIANCE
K852800 · EJF
A Company, Inc.
Dental · 30d
Cleared Jul 31, 1985
GLOSSY POLISHING PASTE
K852814 · EJR
Scientific Pharmaceuticals, Inc.
Dental · 29d
Cleared Jul 31, 1985
DURACLEAN DENTURE CLEANER
K852906 · JER
Astron Dental Corp.
Dental · 22d
Cleared Jul 31, 1985
OHMEDA 5120 OXYGEN MONITOR
K853082 · CCL
Ohmeda Medical
Anesthesiology · 8d
Cleared Jul 30, 1985
NORMALIZED HS3N PROPORTIONAL SERIES HIP STEMS
K844818 · KWL
Osteonics Corp.
Orthopedic · 231d
Cleared Jul 30, 1985
ELECTRODE FOR NEUROLOGICAL SURGERY 2111
K845035 · GYC
Progress Mankind Technology
Neurology · 215d
Cleared Jul 30, 1985
WYLER SUBDURAL STRIP ELECTRODE
K850342 · GYC
Ad-Tech Medical Instrument Corp
Neurology · 183d
Cleared Jul 30, 1985
HOWMEDICA FEMORAL COMPONENT HIP SYS 6259
K851566 · JDG
Howmedica Corp.
Orthopedic · 105d
Cleared Jul 30, 1985
DIAMAT GLYCOSLATED HEMOGLOBIN ANALYZER SYSTEM
K851636 · LCP
Bio-Rad
Hematology · 102d
Cleared Jul 30, 1985
COULTER CHANNELYZER 256
K851736 · GKL
Coulter Electronics, Inc.
Hematology · 96d
Cleared Jul 30, 1985
OSMOCEL 3
K851843 · GIF
Hematology Marketing Assoc.
Hematology · 95d
Cleared Jul 30, 1985
SYSTEM 1085 BODY PLETHYSMOGRAPH
K852088 · CCM
Medical Graphics Corp.
Anesthesiology · 78d
Cleared Jul 30, 1985
PB900 PB910 DIAGNOSTIC SPIROMETER
K852092 · BZG
Puritan Bennett Corp.
Anesthesiology · 77d
Cleared Jul 30, 1985
PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP
K852125 · GQL
Kallestad Laboratories, Inc.
Microbiology · 76d
Cleared Jul 30, 1985
POROCOAT SCHATZKER II ACETABULUM
K852193 · DXQ
Depuy, Inc.
Cardiovascular · 71d
Cleared Jul 30, 1985
LIFESCOPE 8 DEC-8108A AND DEC-8204A
K852270 · DSI
Nihon Kohden America, Inc.
Cardiovascular · 63d
Cleared Jul 30, 1985
THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE
K852283 · KFZ
Thermix, Inc.
Anesthesiology · 62d
Cleared Jul 30, 1985
KELLY-GROERSS-KALL CT STEROTACTIC ADAPTATION SYS
K852477 · HAW
Mayo Clinic
Neurology · 49d
Cleared Jul 30, 1985
CROMIC SURGICAL MICROSCOPE MODEL MC-1
K852586 · HRM
Seltrex, Corp.
General & Plastic Surgery · 42d
Cleared Jul 30, 1985
BIOGLOSS
K852659 · EBF
Dentsply Intl.
Dental · 36d
Cleared Jul 30, 1985
QUIDEL QUEST STREP GROUP A TEST
K852806 · GTZ
Quidel Corp.
Immunology · 27d
Cleared Jul 30, 1985
PENNINE CONNECTING TUBING
K852859
Pennine Medical , Ltd.
General & Plastic Surgery · 25d