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
162289–162312 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 25, 1981
BEAUDENT
K812546 · EBF
Sci-Pharm, Inc.
Dental · 21d
Cleared Sep 25, 1981
COBEAU
K812548 · LBH
Sci-Pharm, Inc.
Dental · 21d
Cleared Sep 25, 1981
BEAUSEAL
K812549 · EBC
Sci-Pharm, Inc.
Dental · 21d
Cleared Sep 25, 1981
BEAUCAV
K812550 · LBH
Sci-Pharm, Inc.
Dental · 21d
Cleared Sep 25, 1981
SWAN-GANZ & EDSLAB HEPARIN COATED CATH.
K812563 · DYG
American Edwards Laboratories
Cardiovascular · 17d
Cleared Sep 25, 1981
CAVITRON
K812568 · EMA
G-C Intl. Corp.
Dental · 16d
Cleared Sep 25, 1981
SHERWOOD WATER TRAP
K812569 · BYH
Sherwood Medical Co.
Anesthesiology · 16d
Cleared Sep 25, 1981
VELCRO FINGER/TOE SPLINT
K812654 · ILH
Maddak, Inc.
Physical Medicine · 8d
Cleared Sep 25, 1981
VELCRO SPLINT STRAP FASTENERS
K812655 · ILH
Maddak, Inc.
Physical Medicine · 8d
Cleared Sep 24, 1981
LACTIC ACID DIALYSATE ADDITIVE
K811706 · KPO
Edlaw Pharmaceuticals, Inc.
Chemistry · 100d
Cleared Sep 24, 1981
CELL-CHEX RBC
K811741 · KRX
Streck Laboratories, Inc.
Hematology · 97d
Cleared Sep 24, 1981
CAROTID ARTERY CLAMP & TOOLS
K811821 · HCE
New England Surgical Instrument Corp.
Neurology · 87d
Cleared Sep 24, 1981
TOWNLEY UNICONDYLAR KNEE
K812012 · HRY
Depuy, Inc.
Orthopedic · 69d
Cleared Sep 24, 1981
INFANT APNEA MONITOR MODEL 100
K812045 · BZQ
Medix Medical Electronics (U.S.A.), Inc.
Anesthesiology · 65d
Cleared Sep 24, 1981
LOW FIBRINOGEN CONTROL
K812108 · KQJ
Bio/Data Corp.
Hematology · 59d
Cleared Sep 24, 1981
LAPIN CLEAR CUT II
K812125 · GEI
Promed Corp.
General & Plastic Surgery · 59d
Cleared Sep 24, 1981
HEMODIALYSIS TRANSDUCER PROTECTOR
K812162 · FIB
Membrana
Gastroenterology & Urology · 57d
Cleared Sep 24, 1981
GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY
K812227 · CFP
Clinical Assays, Inc.
Chemistry · 45d
Cleared Sep 24, 1981
FOAM WEDGE
K812482 · LDQ
Maddak, Inc.
General & Plastic Surgery · 24d
Cleared Sep 24, 1981
BOSCH HEARING INSTRUMENTS
K812503 · CCQ
Retlif, Inc.
Anesthesiology · 23d
Cleared Sep 24, 1981
THE ARTHROFILE
K812506 · HTR
Dyonics, Inc.
General & Plastic Surgery · 23d
Cleared Sep 24, 1981
CORDIA IM
K812540 · KTN
Cordis Corp.
Immunology · 20d
Cleared Sep 24, 1981
TOMAC STERILE DISP. LAP SPONGE
K812554 · GDY
American Convertors Div., American...
General & Plastic Surgery · 16d
Cleared Sep 24, 1981
HDL CHOLESTEROL REAGENT
K812574 · LBR
Pointe Scientific, Inc.,
Chemistry · 15d