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
29425–29448 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 2017
ARROW Anatomical Porous glenoid
K162068 · MBF
Fournitures Hospitalieres Industrie
Orthopedic · 258d
Cleared Apr 10, 2017
Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza...
K162642 · PSZ
Alere Scarborough, Inc.
Microbiology · 200d
Cleared Apr 10, 2017
VORTRAN GO2VENT
K162968 · BTL
Vortran Medical Technology 1, Inc.
Anesthesiology · 168d
Cleared Apr 10, 2017
geko™ T-2 and geko™ Plus R-2 Neuromuscular Stimulators
K163125 · IPF
Firstkind Limited
Physical Medicine · 153d
Cleared Apr 10, 2017
Comfort EC710
K163192 · LNH
Alltech Medical Systems America, Inc.
Radiology · 146d
Cleared Apr 10, 2017
i-Stat Alinity System with i-Stat Glucose test
K163271 · CGA
Abbott Point of Care, Inc.
Chemistry · 140d
Cleared Apr 10, 2017
Keos Lumbar IBFD
K163386 · MAX
Keos
Orthopedic · 129d
Cleared Apr 07, 2017
LED Curing Light
K152192 · EBZ
Monitex Industrial Co., Ltd.
Dental · 611d
Cleared Apr 07, 2017
MEDICAL DIODE LASER SYSTEMS
K160549 · GEX
Wuhan Gigaa Optronics Technology Co.,...
General & Plastic Surgery · 403d
Cleared Apr 07, 2017
Disposable Endotracheal tube, sterile, AccuCuff
K160694 · BTR
Tianjin Medis Medical Device Co., Ltd.
Anesthesiology · 389d
Cleared Apr 07, 2017
Philips iCT CT System
K162838 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 178d
Cleared Apr 07, 2017
VOCSN Unified Respiratory System
K162877 · CBK
Ventec Life Systems, Inc.
General Hospital · 175d
Cleared Apr 07, 2017
gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)
K163144 · FRC
Gke-GmbH
General Hospital · 149d
Cleared Apr 07, 2017
Kepler II
K163265 · ODP
Orbbo Surgical, LLC
Orthopedic · 137d
Cleared Apr 07, 2017
ANTHEM™ Fracture System
K163361 · HRS
Globus Medical, Inc.
Orthopedic · 128d
Cleared Apr 07, 2017
RX Takeru Balloon Dilatation Catheter
K163372 · LOX
KANEKA Corporation
Cardiovascular · 127d
Cleared Apr 07, 2017
Spectranetics Turbo-Elite Laser Atherectomy Catheters
K170059 · MCW
Spectranetics, Inc.
Cardiovascular · 91d
Cleared Apr 07, 2017
ZeroWire Mobile
K170598 · GCJ
Nds Surgical Imaging, LLC
General & Plastic Surgery · 37d
Cleared Apr 07, 2017
NeuroBlate System
K170724 · GEX
Monteris Medical,
General & Plastic Surgery · 29d
Cleared Apr 07, 2017
ORTHOPANTOMOGRAPH OP 3D
K170813 · OAS
Palodex Group OY
Radiology · 21d
Cleared Apr 06, 2017
Howell Biliary Aspiration Needle
K153763 · FCK
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 463d
Cleared Apr 06, 2017
FlowKeepers
K160323 · NGX
Dk Electronics, LLC
Physical Medicine · 426d
Cleared Apr 06, 2017
UNO Negative Pressure Wound Therapy System
K161599 · OMP
Genadyne Biotechnologies, Inc.
General & Plastic Surgery · 301d
Cleared Apr 06, 2017
Huvitz Imaging System
K161829 · NFJ
Huvitz Co., Ltd.
Ophthalmic · 275d