Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
76993–77016 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 05, 2002
ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822
K014204 · DXN
K-Jump Health Co., Ltd.
Cardiovascular · 74d
Cleared Mar 05, 2002
ASTOFLO
K020060 · BSB
Nats Corp.
Hematology · 56d
Cleared Mar 05, 2002
LASERPRO 16
K020243 · LMA
Eradlink, Inc.
Radiology · 41d
Cleared Mar 04, 2002
O-RING PROSTHETIC ATTACHMENT
K001638 · DZE
Titan Implants
Dental · 643d
Cleared Mar 04, 2002
LIFEMATE MLA MULTI-LINE ADAPTOR
K011269 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 312d
Cleared Mar 04, 2002
WRISTORE FIXATOR
K012294 · KTT
Millennium Medical Technologies, Inc.
Orthopedic · 227d
Cleared Mar 04, 2002
INTEGRAPH FLASH, MODEL CI 110
K012732 · JOJ
Steritec Products, Inc.
General Hospital · 200d
Cleared Mar 04, 2002
NEUROSPECTQUAD GAMMA CAMERA
K013353 · KPS
Nuclear Cardiology Systems, Inc.
Radiology · 146d
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