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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
103969–103992 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 07, 1995
COMFIT BLUE POWDER FREE EXAMINATION GLOVES
K943563 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 228d
Cleared Mar 07, 1995
PERCUTANEOUS GRAINAGE CATHETER
K943893 · LJE
Menlo Care, Inc.
Gastroenterology & Urology · 210d
Cleared Mar 07, 1995
IMD PSD 410 PACEMAKER TRANSMITTER
K943995 · DXH
Integrated Medical Devices, Inc.
Cardiovascular · 203d
Cleared Mar 07, 1995
BBLCRYSTAL ANAEROBE ID SYSTEM
K944528 · JSP
Becton Dickinson Microbiology Systems
Microbiology · 173d
Cleared Mar 07, 1995
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K945235 · LTT
Baxter Diagnostics, Inc.
Microbiology · 131d
Cleared Mar 07, 1995
TRIMPORT
K945250 · LJT
Gerard Medical Enterprises, Inc.
General Hospital · 130d
Cleared Mar 07, 1995
DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE
K945294 · JDQ
Howmedica Corp.
Orthopedic · 127d
Cleared Mar 07, 1995
MEDI PLUS SURGEON'S GLOVES
K945363 · KGO
P.T. Saptindo Surgica
General Hospital · 139d
Cleared Mar 07, 1995
DELTA THERM COLD THERAPY SYSTEM
K945399 · ILO
Deltatherm
Physical Medicine · 123d
Cleared Mar 07, 1995
KIRSCHNER (K-WIRE), STEINMAN PINS
K945670 · JDW
Brasseler USA I, L.P.
Orthopedic · 109d
Cleared Mar 07, 1995
RESOUND(R) RESOURCE(TM)
K945750 · ESD
Resound Corp.
Ear, Nose, Throat · 104d
Cleared Mar 07, 1995
SAS(TM) QC ANTIGENS FOR SALMONELLA ANTISERA
K945839 · GRL
Sa Scientific, Inc.
Microbiology · 97d
Cleared Mar 07, 1995
KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
K945964 · LZH
Sherwood Medical Co.
General Hospital · 90d
Cleared Mar 07, 1995
KAO YING
K946010 · LYZ
Kao Ying Industrial Co., Ltd.
General Hospital · 88d
Cleared Mar 07, 1995
FLUOR PROTECTOR
K946032 · LBH
Ivoclar North America, Inc.
Dental · 88d
Cleared Mar 07, 1995
SURGI-LINK BIPOLAR MICRO FORCEPS
K946246 · GEI
Unimed Surgical Products, Inc.
General & Plastic Surgery · 75d
Cleared Mar 07, 1995
KARMA WHEELCHAIR
K950195 · IOR
Karman Healthcare, Inc.
Physical Medicine · 48d
Cleared Mar 07, 1995
AMERICAN DENTAL PRODUCTS (ADP), FLUORIDE RELEASING GLASS IONOMER BAND CEMENT
K950512 · DYH
American Dental Products, Inc.
Dental · 29d
Cleared Mar 07, 1995
TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT
K950514 · DYH
3M Unitek
Dental · 29d
Cleared Mar 07, 1995
THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES
K950655 · ISA
Ultrassage, Inc.
Physical Medicine · 34d
Cleared Mar 06, 1995
CLIRANS WET PACK HOLLOW FIBER DIALYZER
K930503 · FJI
Terumo Medical Corp.
Gastroenterology & Urology · 763d
Cleared Mar 06, 1995
CONCEPTUS VARI-SOFT CATH/PIROUETTE POSIT MANDREL
K932387 · HET
Conceptus, Inc.
Obstetrics & Gynecology · 658d
Cleared Mar 06, 1995
NEWPORT ELECTRONIC MANOMETER
K941309 · CBK
Newport Medical Instruments, Inc.
Anesthesiology · 364d
Cleared Mar 06, 1995
THEMO-FLO SYSTEM 3 LAPAROSCOPIC/HYSTEROSCOPIC SYSTEM
K941507 · HET
Sanese Medical Corp.
Obstetrics & Gynecology · 342d