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

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175,820 results
35665–35688 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 05, 2015
MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb...
K143646 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 73d
Cleared Mar 05, 2015
Vitrea, Version 7.0 Medical Image Processing Software
K150258 · LLZ
Vital Images, Inc.
Radiology · 30d
Cleared Mar 05, 2015
Leva(TM) Spacer System
K150285 · MAX
Spine Wave, Inc.
Orthopedic · 28d
Cleared Mar 04, 2015
NIHON KOHDEN AE-918P NEURO UNIT
K130238 · OMA
Nihon Kohden Corp.
Neurology · 762d
Cleared Mar 04, 2015
DOLPHIN NEUROSTIM OTC
K133789 · NUH
Acumed Medical , Ltd.
Neurology · 447d
Cleared Mar 04, 2015
T3 Software
K142732 · MWI
Etiometry, Inc.
Cardiovascular · 162d
Cleared Mar 04, 2015
SVED Wound Treatment System
K142916 · OMP
Cardinalhealth
General & Plastic Surgery · 148d
Cleared Mar 04, 2015
OCT-Camera
K142953 · HLI
Optomedical Technologies GmbH
Ophthalmic · 145d
Cleared Mar 04, 2015
AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating
K142983 · PNO
Angioscore, Inc.
Cardiovascular · 139d
Cleared Mar 04, 2015
Insta-Gard Surgical and Procedure Face Mask
K142990 · FXX
Cardinal Health200, LLC
General Hospital · 139d
Cleared Mar 04, 2015
Hospira Blood Set
K143087 · FPA
Hospira, Inc.
General Hospital · 128d
Cleared Mar 04, 2015
Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS
K143331 · HRS
Zimmer, Inc.
Orthopedic · 104d
Cleared Mar 04, 2015
iGuide 2.1
K143485 · IYE
Medical Intelligence Medizintechnik GmbH
Radiology · 86d
Cleared Mar 04, 2015
OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control...
K143492 · ERL
Bien-Air Surgery SA
Ear, Nose, Throat · 86d
Cleared CT Mar 04, 2015
Simpliciti Shoulder System
K143552 · PKC
Tornier, Inc.
Orthopedic · 79d
Cleared Mar 04, 2015
EsophyX® Z Fastener Delivery Device
K143645 · ODE
Endogastric Solutions, Inc.
Gastroenterology & Urology · 72d
Cleared Mar 04, 2015
CMOS Video Nasopharyngoscope System
K143673 · EOB
Schoelly Fiberoptic GmbH
Ear, Nose, Throat · 70d
Cleared Mar 04, 2015
Consensus Knee System Modular Tibial Baseplate
K143725 · JWH
Consensus Orthopedics, Inc.
Orthopedic · 65d
Cleared Mar 04, 2015
SALVATION External Fixation System
K150004 · KTT
Wrightmedicaltechnologyinc
Orthopedic · 61d
Cleared Mar 04, 2015
Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic...
K150087 · IYN
Ge Vingmed Ultrasound AS
Radiology · 48d
Cleared Mar 04, 2015
Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen...
K150096 · LAF
Healgen Scientific, LLC
Toxicology · 43d
Cleared Mar 04, 2015
ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound System
K150249 · IYN
Zonare Medical Systems, Inc.
Radiology · 29d
Cleared Mar 04, 2015
Extremity Medical Calcaneal Osteotomy Device
K150309 · HWC
Extremity Medical, LLC
Orthopedic · 23d
Cleared Mar 04, 2015
TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath
K150360 · DRE
Spectranetics, Inc.
Cardiovascular · 20d