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
31633–31656 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 14, 2016
LEONI ORION System
K160518 · JAI
Leoni Cia Cable System
Radiology · 141d
Cleared CT Jul 14, 2016
Soberlink Cellular Device and Sober Sky Web Portal
K160613 · DJZ
Soberlink Healthcare, LLC
Toxicology · 133d
Cleared Jul 14, 2016
AmplifEYE
K160846 · FED
Medivators, Inc.
Gastroenterology & Urology · 108d
Cleared Jul 14, 2016
Wingman 18 Crossing Catheter
K160848 · DQY
Reflow Medical, Inc.
Cardiovascular · 108d
Cleared Jul 14, 2016
Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion...
K160906 · MAX
Spineology, Inc.
Orthopedic · 104d
Cleared Jul 14, 2016
Biopor, AOC Porous Polyethylene, Cerepor
K160988 · KKY
Ceremed , Inc.
General & Plastic Surgery · 97d
Cleared Jul 14, 2016
Powder Free Grey Vinyl Examination Gloves
K161072 · LYZ
Zibo Flourish Trading Co., Ltd.
General Hospital · 87d
Cleared Jul 13, 2016
EXACTECH GPS
K152764 · HAW
Blue Ortho
Neurology · 293d
Cleared Jul 13, 2016
E-Cath
K152952 · BSO
PAJUNK GmbH Medizintechnologie
Anesthesiology · 281d
Cleared Jul 13, 2016
ActiveCare Home
K160431 · JOW
Medical Compression Systems (Dbn) , Ltd.
Cardiovascular · 148d
Cleared Jul 13, 2016
t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device...
K160482 · LZG
Tandem Diabetes Care, Inc.
General Hospital · 142d
Cleared Jul 13, 2016
VALO Grand
K160551 · EBZ
Ultradent Products, Inc.
Dental · 135d
Cleared Jul 13, 2016
LOOK PTFE Suture
K160744 · NBY
Surgical Specialties Corporation
General & Plastic Surgery · 118d
Cleared CT Jul 13, 2016
Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens
K160803 · LPL
CooperVision, Inc.
Ophthalmic · 112d
Cleared Jul 13, 2016
OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)
K160859 · MUW
Contamac, Ltd.
Ophthalmic · 106d
Cleared Jul 13, 2016
PolyDev Soft Contact Lenses
K160977 · LPL
Polydev , Ltd.
Ophthalmic · 97d
Cleared Jul 13, 2016
PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory
K161163 · LHN
Hitachi , Ltd.
Radiology · 79d
Cleared Jul 13, 2016
Multi Modality Viewer
K161419 · LLZ
Vital Images, Inc.
Radiology · 51d
Cleared Jul 13, 2016
TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System
K161525 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 41d
Cleared Jul 12, 2016
SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE
K152803 · FMF
Sung Shim Medicare Co., Ltd.
General Hospital · 288d
Cleared Jul 12, 2016
Gradia Plus
K153325 · EBF
GC America, Inc.
Dental · 236d
Cleared Jul 12, 2016
InMode Plus System
K153568 · PBX
Inmode MD , Ltd.
General & Plastic Surgery · 211d
Cleared Jul 12, 2016
RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set
K160077 · LJE
Jbw7 Innovations, LLC
Gastroenterology & Urology · 180d
Cleared Jul 12, 2016
Apinator
K160123 · LRK
Allen J. Moses, Dds, Ltd.
Dental · 174d