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
30673–30696 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 09, 2016
LUCAS 3 Chest Compression System
K161768 · DRM
Jolife AB
Cardiovascular · 135d
Cleared Nov 09, 2016
Tritanium® PL Cage
K162262 · MAX
Stryker
Orthopedic · 90d
Cleared Nov 09, 2016
Magma Spark
K162781 · GEX
Formatk Systems , Ltd.
General & Plastic Surgery · 37d
Cleared Nov 09, 2016
Raycast High Precision Lung Board Solution
K162862 · IYE
Orfit Industries NV
Radiology · 28d
Cleared Nov 08, 2016
Amendia Interbody Fusion Devices
K160924 · MAX
Amendia, Inc.
Orthopedic · 218d
Cleared Nov 08, 2016
SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive,...
K161011 · MPN
Adhezion Biomedical, LLC
General & Plastic Surgery · 211d
Cleared Nov 08, 2016
Cadwell AmpliScan
K161027 · OMA
Cadwell Industries, Inc.
Neurology · 210d
Cleared Nov 08, 2016
Genesys Spine Apache® Anterior Lumbar Interbody Fusion System
K161438 · MAX
Genesys Spine
Orthopedic · 168d
Cleared Nov 08, 2016
YO Home Sperm Test
K161493 · POV
Medical Electronic Systems , Ltd.
Hematology · 160d
Cleared Nov 07, 2016
MCP Bone Putty
K160446 · MQV
Biostructures, LLC
Orthopedic · 264d
Cleared Nov 07, 2016
Renovo Life Small Bone IM Nail System
K161254 · HSB
Renovo Life, LLC
Orthopedic · 188d
Cleared Nov 07, 2016
MicrO2 OSA Device with Micro-Recorder
K161624 · PLC
Microdental, Inc.
Dental · 147d
Cleared Nov 07, 2016
SPEEDTRAP Graft Preparation System
K161638 · GAT
Medos International SARL
General & Plastic Surgery · 146d
Cleared CT Nov 07, 2016
UltraShape System
K161952 · OHV
Syneron Medical, Ltd.
General & Plastic Surgery · 115d
Cleared Nov 07, 2016
Powder Free Nitrile Examination Gloves (Blue)
K162113 · LZA
Nam Viet Glove Joint Stock Company
General Hospital · 101d
Cleared Nov 07, 2016
P1145 Dental Restorative
K162257 · EBF
Kerr Corporation
Dental · 88d
Cleared Nov 07, 2016
Materialise TKA Guide System
K162273 · JWH
Materialise NV
Orthopedic · 87d
Cleared Nov 07, 2016
dS Small Extremity 16CH 1.5T Coil
K162863 · MOS
Invivo Therapeutics Corporation
Radiology · 25d
Cleared Nov 07, 2016
Irix-C Cervical Integrated Fusion System
K162944 · OVE
X-Spine Systems, Inc.
Orthopedic · 17d
Cleared Nov 04, 2016
ABL90 FLEX PLUS
K160153 · CHL
Radiometer Medical Aps
Chemistry · 287d
Cleared Nov 04, 2016
VSTAAR AdjusteR
K160278 · LXM
Spinal Acoustics, LLC
Physical Medicine · 276d
Cleared Nov 04, 2016
PRIMAGARD Isolation Gown (AAMI PB70 Level 3)
K160361 · FYC
Primed Medical Products, Inc.
General Hospital · 269d
Cleared Nov 04, 2016
Inclusive Abutments
K160979 · NHA
Prismatik Dentalcraft, Inc.
Dental · 211d
Cleared Nov 04, 2016
LipiFlow Thermal Pulsation System
K161357 · ORZ
Tearscience, Inc.
Ophthalmic · 172d