FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
28321–28344 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 2017
Artemis Neuro Evacuation Device
K171332 · GWG
Penumbra, Inc.
Neurology · 98d
Cleared Aug 11, 2017
Paonan Armstrong Posterior Spinal Fixation System
K161225 · NKB
Paonan Biotech Co., Ltd.
Orthopedic · 452d
Cleared Aug 11, 2017
Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway...
K162729 · BSR
Cook Incorporated
Anesthesiology · 316d
Cleared Aug 11, 2017
ADVIA 2120i, ADVIA 2120
K162977 · GKZ
Siemens Healthcare Diagnostics
Hematology · 289d
Cleared Aug 11, 2017
EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only
K163166 · NUH
Easywell Biomedicals, Inc.
Neurology · 270d
Cleared Aug 11, 2017
GenetiSure Dx Postnatal Assay
K163367 · PFX
Agilent Technologies, Inc.
Medical Genetics · 254d
Cleared Aug 11, 2017
NOOSA Anterior Lumbar Plate System
K163625 · KWQ
Signature Orthopaedics Pty, Ltd.
Orthopedic · 232d
Cleared Aug 11, 2017
Breathe Technologies Life2000™ Ventilation System
K170037 · CBK
Breathe Technologies
Anesthesiology · 219d
Cleared Aug 11, 2017
xTAG CYP2D6 Kit v3
K170492 · NTI
Luminex Molecular Diagnostics, Inc.
Toxicology · 175d
Cleared CT Aug 11, 2017
Diacap Pro Dialyzer
K170574 · KDI
B. Braun Avitum AG
Gastroenterology & Urology · 165d
Cleared Aug 11, 2017
TalarLift STS
K170624 · HWC
Fusion Orthopedics, LLC
Orthopedic · 162d
Cleared Aug 11, 2017
Silk'n Infinity
K171433 · OHT
Home Skinovations , Ltd.
General & Plastic Surgery · 88d
Cleared Aug 11, 2017
ShurFit 2C Lumbar Interbody Fusion System
K171657 · MAX
Precision Spine, Inc.
Orthopedic · 67d
Cleared Aug 11, 2017
SOZO
K172122 · OBH
ImpediMed Limited
Gastroenterology & Urology · 29d
Cleared Aug 11, 2017
NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x...
K172140 · QSZ
Polynovo Biomaterials Pty, Ltd.
General & Plastic Surgery · 25d
Cleared Aug 10, 2017
SmartUs EXT-1M/3M
K163121 · IYN
Telemed
Radiology · 275d
Cleared Aug 10, 2017
Peak Left Ventricular Vent Cannula, 20 Fr.
K170488 · DWF
Surge Cardiovascular
Cardiovascular · 174d
Cleared Aug 10, 2017
3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models...
K171116 · MSH
3M Healthcare
General Hospital · 118d
Cleared Aug 10, 2017
Grandio blocs
K171200 · EBF
Voco GmbH
Dental · 108d
Cleared Aug 10, 2017
LENSAR Laser System – fs 3D (LLS-fs 3D)
K171337 · OOE
Lensar, Inc.
Ophthalmic · 94d
Cleared CT Aug 10, 2017
HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty...
K171431 · PST
Biostable Science & Engineering, Inc.
Cardiovascular · 87d
Cleared Aug 10, 2017
MegaVac Mechanical Thrombectomy System
K171493 · QEX
Capture Vascular, Inc.
Cardiovascular · 80d
Cleared Aug 10, 2017
OEC Elite
K171565 · OWB
Ge Oec Medical Systems, Inc.
Radiology · 72d
Cleared Aug 10, 2017
Zimmer Natural Nail System
K172114 · HSB
Zimmer, Inc.
Orthopedic · 28d