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
133945–133968 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 15, 1988
SKID RESISTANT, LONG LASTING SHOE COVERS
K883657 · FXP
James River Corp.
General Hospital · 20d
Cleared Sep 15, 1988
SUNGLASSES, IMPORTED
K883771 · HQY
Norcon, Inc.
Ophthalmic · 9d
Cleared Sep 14, 1988
LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE
K870722 · FJK
National Medical Care, Medical...
Gastroenterology & Urology · 587d
Cleared Sep 14, 1988
MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS
K881478 · KNQ
Keymed (Medical & Industrial...
Gastroenterology & Urology · 161d
Cleared Sep 14, 1988
BREAST LESION LOCALIZATION NEEDLE
K881697 · IZH
Bd Becton Dickinson Vacutainer...
Radiology · 148d
Cleared Sep 14, 1988
OMEGA NV(TM) BALLOON DILATATION CATHETER
K882052 · LIT
Cook, Inc.
Cardiovascular · 121d
Cleared Sep 14, 1988
SHIMADZU LATERAL C-ARM MH-31
K882311 · JAA
Shimadzu Precision Instruments, Inc.
Radiology · 103d
Cleared Sep 14, 1988
MEDTRONIC EPIDURAL CATHETER KIT MODEL 8716
K882394 · CAZ
Medtronic Vascular
Anesthesiology · 96d
Cleared Sep 14, 1988
COULTER CLONE B1 MONOCLONAL ANTIBODY
K882557 · GKZ
Coulter Immunology
Hematology · 85d
Cleared Sep 14, 1988
DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEM
K883072 · IZI
Siemens Gammasonics, Inc.
Radiology · 56d
Cleared Sep 14, 1988
PROLOG MP 658M PULSE GENERATOR
K883087 · DXY
Pacesetter Systems
Cardiovascular · 55d
Cleared Sep 14, 1988
AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR)
K883434 · BTM
Ambu, Inc.
Anesthesiology · 30d
Cleared Sep 14, 1988
INSTRUMENTARIUM ULF MR IMAGING SYSTEM
K883622 · LNH
Instrumentarium Corp.
Radiology · 20d
Cleared Sep 13, 1988
STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT
K875280 · MED
Steris C/O Medical Device...
General Hospital · 264d
Cleared Sep 13, 1988
MRM GASTROSTOMY BELT
K882089 · KNT
Mrm Products, Inc.
Gastroenterology & Urology · 117d
Cleared Sep 13, 1988
COMPAT (R) ENTERAL DELIVERY SYSTEM
K882218 · KNT
Sandoz Nutrition
Gastroenterology & Urology · 110d
Cleared Sep 13, 1988
FILLING VOLUME OPTION
K882295 · LJH
Eris Medical Technology
Gastroenterology & Urology · 103d
Cleared Sep 13, 1988
PUNCH MYRINGOTOMY SYSTEM
K882689 · ETD
Xomed, Inc.
Ear, Nose, Throat · 75d
Cleared Sep 13, 1988
FRESENIUS F8 DIALYZER
K883195 · KDI
Fresenius USA, Inc.
Gastroenterology & Urology · 47d
Cleared Sep 13, 1988
TECHNICON RA-100(TM) SYSTEM
K883209 · JJE
Technicon Instruments Corp.
Chemistry · 46d
Cleared Sep 13, 1988
LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL
K883247 · JJY
Quantimetrix Medical Industries
Chemistry · 42d
Cleared Sep 13, 1988
PRL-QUANT
K883269 · CFT
Leeco Diagnostics, Inc.
Chemistry · 41d
Cleared Sep 13, 1988
EMAX PRECISION MICROPLATE READER
K883302 · JJQ
Molecular Devices Corp.
Chemistry · 40d
Cleared Sep 13, 1988
VENTREX COATED TUBE TSH
K883342 · JLW
Ventrex Laboratories, Inc.
Chemistry · 35d