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
31129–31152 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 14, 2016
dS FootAnkle I6CH 1.5T Coil
K162177 · MOS
Invivo Corporation
Radiology · 41d
Cleared Sep 14, 2016
TSolution One Cup1 Surgical System
K162195 · OLO
THINK Surgical, Inc.
Orthopedic · 40d
Cleared Sep 14, 2016
CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System
K162329 · IYN
Philips Health Care
Radiology · 26d
Cleared Sep 13, 2016
Initial LiSi Block
K153130 · EIH
GC America, Inc.
Dental · 319d
Cleared Sep 13, 2016
TXM Guiding Sheath
K153771 · DYB
Texasmedical Technologies, Inc.
Cardiovascular · 258d
Cleared Sep 13, 2016
OptoMonitor II
K161263 · DXO
Opsens, Inc.
Cardiovascular · 131d
Cleared Sep 13, 2016
TR-100
K161551 · PBX
BTL Industries, Inc.
General & Plastic Surgery · 102d
Cleared Sep 12, 2016
Implance Dental Implant System, Implance Dental Abutment System
K160221 · DZE
Ags Medikal Urunleri Ith. Ihr. Tic....
Dental · 227d
Cleared Sep 12, 2016
Pavati Z40.2 Zirconia
K160867 · EIH
Ccri, Inc.
Dental · 166d
Cleared CT Sep 12, 2016
Profound System
K161043 · PBX
Syneron Candela Corporation
General & Plastic Surgery · 152d
Cleared Sep 12, 2016
JULIET® LL Lateral Lumbar Cage
K161888 · MAX
Spineart
Orthopedic · 63d
Cleared Sep 11, 2016
NeuroStar TMS Therapy System
K161519 · OBP
Neuronetics, Inc.
Neurology · 101d
Cleared Sep 09, 2016
AMC Health VitalCaregiving System
K151839 · MWI
Amc Health
Cardiovascular · 431d
Cleared Sep 09, 2016
Sure-Fine Insulin Syringes
K152879 · FMF
Shina Med Corporation
General Hospital · 345d
Cleared Sep 09, 2016
Liberator Powered Wheelchair with Solar Companion
K153636 · ITI
Solar Mobilityllc
Physical Medicine · 266d
Cleared Sep 09, 2016
ULYSS Multi View Sinuscope
K153701 · EOB
Sopro-Comeg GmbH
Ear, Nose, Throat · 261d
Cleared Sep 09, 2016
AbClose - Port Site Closure Device
K160117 · OCW
Medeon Biodesign, Inc.
General & Plastic Surgery · 234d
Cleared Sep 09, 2016
Enseal X1 Large Jaw Tissue Sealer
K160554 · GEI
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 193d
Cleared Sep 09, 2016
Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)
K160754 · GEI
Venclose, Inc.
General & Plastic Surgery · 175d
Cleared Sep 09, 2016
S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV
K160822 · BZD
Resmed, Ltd.
Anesthesiology · 169d
Cleared Sep 09, 2016
Self-retaining Retractor
K161004 · GZT
Fetzer Medical GmbH & Co. KG
Neurology · 151d
Cleared Sep 09, 2016
All-Bond Universal w/BAC (not finalized)
K161051 · KLE
Bisco, Inc.
Dental · 148d
Cleared Sep 09, 2016
EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with...
K161187 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 135d
Cleared CT Sep 09, 2016
ClearRead CT
K161201 · OEB
Riverain Technologies, LLC
Radiology · 134d