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
35617–35640 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 11, 2015
DRX-EVOLUTION
K141837 · KPR
Carestream Health, Inc.
Radiology · 247d
Cleared Mar 11, 2015
XIDF-AWS801, Angio Workstation, v5.31
K142736 · OWB
Toshibamedical Systems Corporation
Radiology · 169d
Cleared Mar 11, 2015
Attain Hybrid Guide Wire
K143316 · DQX
Medtronic, Inc.
Cardiovascular · 112d
Cleared Mar 11, 2015
LIAISON VZV IgG, LIAISON Control VZV IgG
K150375 · LFY
DiaSorin, Inc.
Microbiology · 26d
Cleared Mar 10, 2015
PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH, BLUNT TIP,PLASTIC...
K141624 · JAQ
Varian Medical Systems, Inc.
Radiology · 266d
Cleared Mar 10, 2015
BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON
K142068 · OCX
Medovations, Inc.
Gastroenterology & Urology · 223d
Cleared Mar 10, 2015
Martinez Prostate Template Set
K142439 · JAQ
Nucletron B.V.
Radiology · 193d
Cleared Mar 10, 2015
Aquilion ONE Vision, v7.0
K142465 · JAK
Toshibamedical Systems Corporation
Radiology · 189d
Cleared Mar 10, 2015
Sense4Baby System Model B+ (MSA)
K143114 · LQK
Airstrip Technologies, Inc.
Obstetrics & Gynecology · 131d
Cleared Mar 10, 2015
DR Systems Zero Download 3D Viewer (Z3D)
K143318 · LLZ
Dr Systems, Inc.
Radiology · 111d
Cleared Mar 10, 2015
Hill-Rom Wireless Connectivity Module
K143414 · IOQ
Hill-Rom
Physical Medicine · 102d
Cleared Mar 10, 2015
The MeDioStar NeXT Family
K143519 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 88d
Cleared Mar 10, 2015
Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio
K143753 · MUH
Rayence Co., Ltd.
Radiology · 69d
Cleared Mar 10, 2015
RESTORIS Multicompartmental Knee System
K150307 · NPJ
Mako Surgical Corp.
Orthopedic · 29d
Cleared Mar 09, 2015
PACSEAL PIT & FISSURE SEALANT
K141717 · EBC
Pac-Dent International, Inc.
Dental · 257d
Cleared Mar 09, 2015
ID MILLENNIUM, ID MOMENTS SILICONE
K141767 · NUC
Westridge Laboratories, Inc.
Obstetrics & Gynecology · 251d
Cleared Mar 09, 2015
ASAHI FUBUKI 043 / ASAHI FUBUKI
K141981 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 231d
Cleared Mar 09, 2015
KIMGUARD ONE-STEP Sterilization Wrap
K142782 · FRG
Kimberly-Clark Health Care
General Hospital · 164d
Cleared Mar 09, 2015
CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure...
K142808 · GDW
C.R. Bard, Inc.
General & Plastic Surgery · 161d
Cleared Mar 09, 2015
Schoelly Cystoscopes/Hysteroscopes and Accessories
K150158 · HIH
Schoelly Fiberoptic GmbH
Obstetrics & Gynecology · 45d
Cleared Mar 09, 2015
Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis...
K150275 · DJG
Immunalysis Corporation
Toxicology · 33d
Cleared Mar 06, 2015
VIEWING CLIENT MOBILE
K141536 · LLZ
Axon Medical Technologies Corp.
Radiology · 269d
Cleared Mar 06, 2015
AQANIFE
K141790 · GEI
Ovesco Endoscopy AG
General & Plastic Surgery · 247d
Cleared Mar 06, 2015
PULMONE MINIBOXPFT 2.0
K141793 · BZG
Pulmone Advanced Medical Devices, Ltd.
Anesthesiology · 247d