FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
76393–76416 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 04, 2002
CARBODISSECTING ENDOSCOPE
K013680 · GEI
Endo Surgical Devices, Inc.
General & Plastic Surgery · 117d
Cleared Mar 04, 2002
INFRARED EAR THERMOMETER, MODEL DX-707
K013876 · FLL
Jawon Medical Co., Ltd.
General Hospital · 101d
Cleared Mar 04, 2002
ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890
K014002 · KOB
Fortune Medical Instrument Corp.
Gastroenterology & Urology · 90d
Cleared Mar 04, 2002
MRI LINE MARKER
K014022 · IYE
I.Z.I. Corp.
Radiology · 88d
Cleared Mar 04, 2002
MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT)
K014044 · HOQ
Notal Vision, Inc.
Ophthalmic · 87d
Cleared Mar 04, 2002
LATEXX MANUFACTURING NON-CHLORINATED, POLYMER COATED, POWDER-FREE RUBBER...
K014087 · LYY
Latexx Manufacturing Sdn.Bhd.
General Hospital · 83d
Cleared Mar 04, 2002
STAURENGHI WIDE FIELD SCANNING LASER LENS
K014170 · HJK
Ocular Instruments, Inc.
Ophthalmic · 74d
Cleared Mar 04, 2002
SONOREAL 3D SYSTEM
K020068 · IYO
Bio Medi Com
Radiology · 54d
Cleared Mar 04, 2002
AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP...
K020137 · EGS
Aseptico, Inc.
Dental · 47d
Cleared Mar 04, 2002
TEMPORARY CROWN AND BRIDGE MATERIAL
K020157 · EBG
J. Morita USA, Inc.
Dental · 46d
Cleared Mar 04, 2002
INVIGRA
K020223 · HIS
Indus Medicare , Ltd.
Obstetrics & Gynecology · 41d
Cleared Mar 04, 2002
ENDOPATH DILATING TIP TROCAR, MODEL #512XD
K020428 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 24d
Cleared Mar 04, 2002
TRIDENT ELEVATED RIM LINER
K020497 · LPH
Howmedica Osteonics Corp.
Orthopedic · 18d
Cleared Mar 04, 2002
ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM
K020572 · MEH
Howmedica Osteonics Corp.
Orthopedic · 11d
Cleared Mar 01, 2002
AESCULAP -MIETHKE SHUNT SYSTEM
K011030 · JXG
Aesculap, Inc.
Neurology · 330d
Cleared Mar 01, 2002
DRG DISPOSABLE VAGINAL SPECULUM
K012535 · HIB
Doctor'S Research Group, Inc.
Obstetrics & Gynecology · 206d
Cleared Mar 01, 2002
KONICA DIRECT DIGITIZER REGIUS MODEL 350
K013054 · MQB
Konica Minolta Medical & Graphic, Inc.
Radiology · 171d
Cleared Mar 01, 2002
MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON
K013737 · FGE
Telemed Systems, Inc.
Gastroenterology & Urology · 108d
Cleared Mar 01, 2002
REPROCESSED DISPOSABLE TROCARS
K013987 · KBG
Adven Medical
Ear, Nose, Throat · 87d
Cleared Mar 01, 2002
MODIFICATION TO EBI XFIX DFS SYSTEM
K014276 · KTT
Ebi, L.P.
Orthopedic · 64d
Cleared Mar 01, 2002
SAFETOUCH
K014300 · NHM
James D Rusin MD, MBA
Obstetrics & Gynecology · 60d
Cleared Mar 01, 2002
ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500
K020128 · JHI
Diagnostic Systems Laboratories, Inc.
Chemistry · 45d
Cleared Mar 01, 2002
MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT...
K020340 · DQX
Guidant Corp.
Cardiovascular · 28d
Cleared Mar 01, 2002
MODIFICATION TO VIGIL LIPID CONTROL
K020521 · JJY
Beckman Coulter, Inc.
Chemistry · 10d