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
136297–136320 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 10, 1988
OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES
K874635 · JWH
Osteonics Corp.
Orthopedic · 121d
Cleared Mar 10, 1988
FLORIDA PROBE
K875076 · EIX
Florida Probe Corp.
Dental · 92d
Cleared Mar 10, 1988
SIEMENS NEUROTON 826 AND 827
K875238 · IPF
Elmed, Inc.
Physical Medicine · 79d
Cleared Mar 10, 1988
PORCELAIN VENEER RESIN CEMENT W/DUAL CURE CATALYST
K875313 · EBF
Bisco, Inc.
Dental · 72d
Cleared Mar 09, 1988
CONTATTO CONDOMS
K871744 · HIS
Razi Corp.
Obstetrics & Gynecology · 309d
Cleared Mar 09, 1988
KETAC-CONDITIONER
K872984 · EMA
Espe GmbH (Us)
Dental · 222d
Cleared Mar 09, 1988
INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING
K873498 · BXR
Dhd Medical Products Div. Diemolding...
Anesthesiology · 191d
Cleared Mar 09, 1988
AUTOTRANSFUSION APPARATUS
K873807 · CAC
Biodynamics Corp.
Anesthesiology · 173d
Cleared Mar 09, 1988
COULTER CLONE T11 MONOCLONAL ANTIBODY
K875047 · GKZ
Coulter Electronics, Inc.
Hematology · 92d
Cleared Mar 09, 1988
HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARIN
K875089 · JPA
Hemotec, Inc.
Hematology · 91d
Cleared Mar 09, 1988
PERMADYNE ADHESIVE
K875228 · EBH
Espe GmbH (Us)
Dental · 78d
Cleared Mar 09, 1988
IMPREGUM F ADHESIVE
K875257 · EBH
Espe GmbH (Us)
Dental · 78d
Cleared Mar 09, 1988
LAKE CATHETER CARE KITS (MODIFICATION)
K875383 · KOD
Lake Medical Products, Inc.
Gastroenterology & Urology · 85d
Cleared Mar 09, 1988
MEMORYMATE HEARING AID MODEL 8200
K880082 · ESD
3M Company
Ear, Nose, Throat · 57d
Cleared Mar 09, 1988
CEMAX 5000 MULTIDIMENSIONAL IMAGING WORKSTATION
K880169 · LLZ
Cemax, Inc.
Radiology · 54d
Cleared Mar 09, 1988
BEAVERS' DENTAL DIAMOND INSTRUMENTS
K880179 · DZP
Beavers Dental, Div. Sybron Canada, Ltd.
Dental · 56d
Cleared Mar 09, 1988
VIBRASOUND IN-THE-EAR HEARING AID
K880184 · ESD
Vibrasound Research Corp.
Ear, Nose, Throat · 54d
Cleared Mar 09, 1988
MAGIC EAR MODEL CI IN-THE-EAR HEARING AID
K880225 · ESD
Audiotone, Inc.
Ear, Nose, Throat · 49d
Cleared Mar 09, 1988
PACEART PACEMAKER PATIENT TEST SYST/TEL OPT CPTS
K880283 · DXH
Paceart, Inc.
Cardiovascular · 47d
Cleared Mar 09, 1988
MOBILE C-ARM OMNI 325
K880518 · OXO
Fischer Imaging Corp.
Radiology · 29d
Cleared Mar 09, 1988
SHILEY DISP. CANNULA CUFFLESS TRACEOSTOMY TUBE
K880614 · BTO
Shiley, Inc.
Anesthesiology · 22d
Cleared Mar 09, 1988
IN THE EAR HEARING AID
K880635 · ESD
Tallahassee Hearing Aid Center
Ear, Nose, Throat · 22d
Cleared Mar 09, 1988
MORTARA INSTRUMENT MODEL ELI-XR (TREADMILL INCLUDED)
K880664 · DSI
Mortara Instrument, Inc.
Cardiovascular · 20d
Cleared Mar 09, 1988
KING SYSTEMS, DISP. ANESTHESIA BREATHING CIRCUIT
K880683 · CAI
King Systems Corp.
Anesthesiology · 19d