FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
33889–33912 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 23, 2015
PROTOCOL Incision Dressing
K142962 · FRO
Deroyal Industries
General & Plastic Surgery · 282d
Cleared Jul 23, 2015
RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal...
K143133 · OMP
Smith & Nephew, Inc.
General & Plastic Surgery · 265d
Cleared Jul 23, 2015
Q6 Edge EM
K143383 · ITI
Pride Mobility Product Corporation
Physical Medicine · 240d
Cleared Jul 23, 2015
Digital Automatic Blood Pressure Monitor MD2300
K143735 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 205d
Cleared Jul 23, 2015
ORL Video NasoPharyngo-Larngoscope
K150248 · EQN
Jedmed Instrument Company
Ear, Nose, Throat · 170d
Cleared Jul 23, 2015
Muscle Stimulation System 110
K150742 · IPF
Niveus Medical, Inc.
Physical Medicine · 122d
Cleared Jul 23, 2015
E-CUBE 15 Diagnostic Ultrasound System
K150773 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 121d
Cleared Jul 23, 2015
CinchLock Flex Knotless Suture Anchor
K151314 · MBI
Pivot Medical
Orthopedic · 66d
Cleared Jul 23, 2015
KYPHON ELEMENT Inflatable Bone Tamp
K151532 · HRX
Medtronic, Inc.
Orthopedic · 45d
Cleared Jul 23, 2015
Magellan Robotic System
K151730 · DXX
Hansen Medical, Inc.
Cardiovascular · 27d
Cleared Jul 22, 2015
PATHWAY ELIF
K143143 · MAX
Custom Spine, Inc.
Orthopedic · 261d
Cleared Jul 22, 2015
TM-ABI system
K143152 · JOM
Ld Technology, LLC
Cardiovascular · 261d
Cleared Jul 22, 2015
Powder-Free White Vinyl Patient Examination Gloves
K143346 · LYZ
Zibo Changda Plastic Products...
General Hospital · 243d
Cleared Jul 22, 2015
Nutra Light Advanced
K150370 · OLP
Nutra Luxe MD, LLC
General & Plastic Surgery · 159d
Cleared Jul 22, 2015
Zeramic Adhesive Resin Cement
K150601 · EMA
Premier Dental Company Products
Dental · 134d
Cleared Jul 22, 2015
LaserCap LC Pro and LC Elite
K150613 · OAP
Transdermal Cap, Inc.
General & Plastic Surgery · 134d
Cleared Jul 22, 2015
Cordelle II Sound Processor
K150751 · LXB
Cochlear Americas
Ear, Nose, Throat · 121d
Cleared Jul 22, 2015
iFuse Implant System
K150875 · OUR
SI-BONE, Inc.
Orthopedic · 112d
Cleared Jul 22, 2015
Rampart-T Interbody Fusion System
K151020 · MAX
Spineology, Inc.
Orthopedic · 97d
Cleared Jul 22, 2015
Ventilation (Tympanostomy) Tubes
K151067 · ETD
Medtronic Xomed, Inc.
Ear, Nose, Throat · 92d
Cleared Jul 22, 2015
CoSense ETCO Monitor
K151107 · CCJ
Capnia, Inc.
Anesthesiology · 86d
Cleared Jul 22, 2015
ELITech Clinical Systems CALCIUM ARSENAZO
K151113 · CJY
Elitechgroup
Chemistry · 86d
Cleared Jul 22, 2015
Retracta Detachable Embolization Coil
K151676 · KRD
Cook Incorporated
Cardiovascular · 30d
Cleared Jul 21, 2015
DENTCA DENTURE BASE
K143033 · EBI
Dentca, Inc.
Dental · 272d