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
68449–68472 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 05, 2004
STURDY MANUAL RESUSCITATOR
K032596 · BTM
Sturdy Industrial Co., Ltd.
Anesthesiology · 349d
Cleared Aug 05, 2004
NEXFLEX TOTAL HIP SYSTEM
K033580 · LPH
Nexmed, Inc.
Orthopedic · 266d
Cleared Aug 05, 2004
SILVERSEAL
K033587 · FRO
Noble Fiber Technologies
General & Plastic Surgery · 266d
Cleared Aug 05, 2004
STRYKER SPINE VERTEBRAL SPACER
K040731 · MQP
Stryker Spine
Orthopedic · 136d
Cleared Aug 05, 2004
VILEX BONE PLATE SYSTEM
K041287 · HWC
Vilex, Inc.
Orthopedic · 84d
Cleared Aug 05, 2004
TALUS OF VILEX (TOV)
K041289 · HWC
Vilex, Inc.
Orthopedic · 84d
Cleared Aug 05, 2004
ANTIMICROBIAL ALGINATE DRESSING
K041316 · FRO
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 80d
Cleared Aug 05, 2004
INFUSIONCATH
K041517 · QEY
Id, LLC
Cardiovascular · 59d
Cleared Aug 05, 2004
ARTHREX FIBERWIRE WITH SILK
K041589 · GAT
Arthrex, Inc.
General & Plastic Surgery · 55d
Cleared Aug 05, 2004
KARMA SCOOTER, MODEL KS-747.2
K041677 · INI
Karma Medical Products Co., Ltd.
Physical Medicine · 45d
Cleared Aug 05, 2004
CLIP 'N'JECT RECONSTITUTION SYSTEM (CLIP 'N'JECT
K041691 · LHI
West Pharmaceutical Services, Inc.
General Hospital · 44d
Cleared Aug 05, 2004
LVI AESTHETIC LASER
K041721 · GEX
Hoya Photonics, Inc.
General & Plastic Surgery · 42d
Cleared Aug 05, 2004
TEH LIN POWERED WHEELCHAIR, MDG-601
K041752 · ITI
Teh Lin Prosthetic & Orthopaedic, Inc.
Physical Medicine · 37d
Cleared Aug 04, 2004
ULTRABIO
K033178 · MUI
Sonotech, Inc.
Radiology · 308d
Cleared Aug 04, 2004
GEODESIC EEG SYSTEM SERIES 100
K033399 · GWQ
Electrical Geodesics, Incorporated
Neurology · 285d
Cleared Aug 04, 2004
PORE-SI BONE GRAFT SUBSTITUTE
K040082 · MQV
Apatech , Ltd.
Orthopedic · 202d
Cleared Aug 04, 2004
HES ULTRASONIC THERAPY APPLIANCE
K040798 · IMI
Hwang Sun Enterprise Co., Ltd.
Physical Medicine · 128d
Cleared Aug 04, 2004
ELECTRO
K041219 · ITI
Permobil AB
Physical Medicine · 86d
Cleared Aug 04, 2004
EVA TPN CONTAINER
K041415 · KPE
B.Braun Medical, Inc.
General Hospital · 69d
Cleared Aug 04, 2004
MODIFICATION TO: ON-BOARD IMAGER DEVICE
K041519 · IYE
Varian Medical Systems, Inc.
Radiology · 58d
Cleared Aug 04, 2004
PROVISO
K041886 · EBG
Scientific Pharmaceuticals, Inc.
Dental · 23d
Cleared Aug 04, 2004
HEMO-DOP
K041915 · IYN
Dwl Elektronische Systeme GmbH
Radiology · 19d
Cleared Aug 03, 2004
NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000
K033685 · KRH
Medical Cv, Inc.
Cardiovascular · 253d
Cleared Aug 03, 2004
PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES
K033730 · GZL
Pmt Corp.
Neurology · 249d