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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
34945–34968 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 29, 2015
Exactech Optetrak Logic CC
K150890 · JWH
Exactech, Inc.
Orthopedic · 57d
Cleared May 29, 2015
Signia Loading Unit, Tri-Staple 2.0 Cartridge
K151163 · GDW
Covidien, LLC
General & Plastic Surgery · 28d
Cleared May 28, 2015
LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids...
K141320 · LDJ
Lin-Zhi International, Inc.
Toxicology · 373d
Cleared May 28, 2015
URISCAN OPTIMA
K141874 · KQO
Yd Diagnostics Corp.
Chemistry · 321d
Cleared CT May 28, 2015
Vaginal Tactile Imager
K142355 · HIR
Advanced Tactile Imaging, Inc.
Gastroenterology & Urology · 276d
Cleared May 28, 2015
ViMove
K142494 · IKN
Dorsavi, Ltd.
Neurology · 265d
Cleared May 28, 2015
Captiva Spine FuselOX Cervical IBF System
K142586 · ODP
Captiva Spine
Orthopedic · 255d
Cleared May 28, 2015
PTA 14 Balloon Dilatation Catheter OTW
K142954 · LIT
Texasmedical Technologies, Inc.
Cardiovascular · 230d
Cleared May 28, 2015
SMR Modular Glenoid
K143256 · KWS
Lima Corporate S.P.A.
Orthopedic · 196d
Cleared May 28, 2015
Mandible External Fixator - MR Conditional
K143285 · MQN
Synthes USA Products, LLC
Dental · 192d
Cleared May 28, 2015
AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION)
K150129 · EKX
Aseptico, Inc.
Dental · 127d
Cleared May 28, 2015
Ascendant TM Cervical Spacer System
K150130 · ODP
Exactech, Inc.
Orthopedic · 127d
Cleared May 28, 2015
Imed Technology Intravascular Administration Set, Imed Technology Extension Set
K150513 · FPA
Imed Technology, Inc.
General Hospital · 90d
Cleared May 28, 2015
Heavy Double Flexible Tipped Wire Guide
K150802 · DQX
Cook Incorporated
Cardiovascular · 63d
Cleared May 28, 2015
TD-Wand
K150824 · GEI
Tdm Surgitech, Inc.
General & Plastic Surgery · 57d
Cleared May 27, 2015
Synapse Transcutaneous Electrical Stimulation Device
K143198 · GZJ
Synapse Electroceutical Limited
Neurology · 202d
Cleared May 27, 2015
Medtronic Patient Asistant
K150117 · DSI
Medtronic, Inc.
Cardiovascular · 127d
Cleared May 27, 2015
SpiroThor
K150137 · BZG
Cohero Health, LLC
Anesthesiology · 125d
Cleared May 27, 2015
Shaser Skin Beauty Intense Pulsed Light System Family for Acne
K150282 · ONF
Shaser, Inc.
General & Plastic Surgery · 111d
Cleared May 27, 2015
Coating Material
K150511 · EBI
Sun Medical Co., Ltd.
Dental · 89d
Cleared May 27, 2015
Rapid Aid Instant Disposable Infant Heel Warmer
K150627 · MPO
Rapid Aid Corp.
Physical Medicine · 77d
Cleared May 27, 2015
IntelePACS
K150707 · LLZ
Intelerad Medical Systems Incorporated
Radiology · 69d
Cleared May 27, 2015
Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic...
K150927 · OCY
Coloplast A/S
Gastroenterology & Urology · 51d
Cleared May 27, 2015
Intersept Filtered Cardiotomy Reservoir
K151110 · DTN
Medtronic, Inc.
Cardiovascular · 30d