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
33361–33384 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 10, 2015
AccuCath Intravascular Catheter
K153298 · FOZ
C.R. Bard, Inc.
General Hospital · 27d
Cleared Dec 09, 2015
Biodesign Enterocutaneous Fistula Plug
K150668 · FTM
Cook Biotech Incorprated
General & Plastic Surgery · 268d
Cleared Dec 09, 2015
PENTRA XLR
K151133 · GKZ
HORIBA ABX SAS
Hematology · 225d
Cleared Dec 09, 2015
D-100 HbA1c, D-100 HbA1c Calibrator Pack
K151321 · PDJ
Bio-Rad Laboratories, Inc.
Chemistry · 205d
Cleared Dec 09, 2015
MIVI Mi-AXUS Guide Catheter
K151396 · DQY
Mivi Neuroscience, Inc.
Cardiovascular · 197d
Cleared Dec 09, 2015
One Coat 7 Universal
K152243 · KLE
Coltene/Whaledent AG
Dental · 121d
Cleared Dec 09, 2015
Touch Ultrasound
K152467 · IYN
Carestream Health, Inc.
Radiology · 100d
Cleared Dec 09, 2015
da Vinci Xi Hasson Cone
K153126 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 41d
Cleared Dec 09, 2015
ProParaFlu+ Assay
K153223 · OOU
Hologic, Inc.
Microbiology · 33d
Cleared Dec 08, 2015
Varaya Sport
K150716 · ILY
Varaya Photoceuticals, LLC
Physical Medicine · 264d
Cleared Dec 08, 2015
higi Station
K151127 · DXN
Higi Sh, LLC
Cardiovascular · 224d
Cleared Dec 08, 2015
EVO platform
K152012 · GEX
Quanta System Spa
General & Plastic Surgery · 140d
Cleared Dec 08, 2015
High Speed Handpieces and Accessories
K152146 · EFB
Codent Technical Industry Co., Ltd.
Dental · 127d
Cleared Dec 08, 2015
Cytal Wound Matrix
K152721 · KGN
Acell, Inc.
General & Plastic Surgery · 78d
Cleared Dec 08, 2015
neoV980 & neoV1470 Diode Lasers
K152722 · GEX
G.N.S Neolaser , Ltd.
General & Plastic Surgery · 77d
Cleared Dec 07, 2015
ABL80 FLEX and ABL80 FLEX CO-OX
K151639 · CGA
Sendx Medical, Inc.
Chemistry · 172d
Cleared Dec 07, 2015
Houdini Catheter
K151896 · DQY
Cruzar Medsystems, Inc.
Cardiovascular · 150d
Cleared Dec 07, 2015
ROI-C Titanium-Coated Implant System
K151934 · OVE
Ldr Spine USA
Orthopedic · 146d
Cleared Dec 07, 2015
Respire Blue Series-EF
K152292 · LRK
Respire Medical Holding
Dental · 116d
Cleared Dec 07, 2015
Suntanning Lamps
K152436 · LEJ
Interlectric Corporation
General & Plastic Surgery · 102d
Cleared Dec 07, 2015
XSTAT 30, 3-PACK, XSTAT 30, 1-PACK
K152624 · PGZ
Revmedx, Inc.
General & Plastic Surgery · 84d
Cleared Dec 07, 2015
Merit 20 mL Syringe
K152783 · FMF
Merit Medical Systems, Inc.
General Hospital · 73d
Cleared Dec 06, 2015
Vital Connect Platform, HealthPatch MD, VitalPatch
K152139 · DRG
Vitalconnect, Inc.
Cardiovascular · 125d
Cleared Dec 04, 2015
iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart...
K150833 · NBW
Andon Health Co, Ltd.
Chemistry · 249d