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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
70273–70296 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 14, 2003
MOBILETTE XP AND MOBILETT XPHYBRID
K033238 · IZL
Siemens Medical Systems, Inc.
Radiology · 39d
Cleared Nov 14, 2003
DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS
K033329 · HSB
Depuy, Inc.
Orthopedic · 29d
Cleared Nov 14, 2003
SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B
K033333 · FGE
Aomori Olympus Co., Ltd.
Gastroenterology & Urology · 29d
Cleared Nov 14, 2003
MODIFICATION TO LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES
K033353 · MOS
Usa Instruments, Inc.
Radiology · 25d
Cleared Nov 14, 2003
CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000
K033358 · LIH
Surgitech, Inc.
Neurology · 25d
Cleared Nov 14, 2003
AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE
K033468 · DTM
Medtronic Perfusion Systems
Cardiovascular · 11d
Cleared Nov 13, 2003
COPC BAND
K021594 · MVA
Center For Orthotic and Prosthetic...
Neurology · 547d
Cleared Nov 13, 2003
POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE BROTHERS
K031170 · LYZ
Long First (Xiamen) Co., Ltd.
General Hospital · 213d
Cleared Nov 13, 2003
RAINBOW GT-4A PAIN RELIEF MACHINE
K031546 · GZJ
Sino-Us Information, Inc.
Neurology · 181d
Cleared Nov 13, 2003
DENTATUS OSCIOMAT
K031793 · DZH
Dentatus USA , Ltd.
Dental · 156d
Cleared Nov 13, 2003
NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR...
K032444 · LZC
Cardinalhealth
General Hospital · 97d
Cleared Nov 13, 2003
PROFILE BBL SYSTEM
K032460 · GEX
Sciton, Inc
General & Plastic Surgery · 94d
Cleared Nov 13, 2003
NUVASIVE MESH
K032476 · MQP
Nuvasive, Inc.
Orthopedic · 93d
Cleared Nov 13, 2003
ZOLL AUTOCLAVABLE INTERNAL HANDLES
K032691 · LDD
Zoll Medical Corp
Cardiovascular · 72d
Cleared Nov 13, 2003
ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM
K032744 · JCT
Alveolus, Inc.
General & Plastic Surgery · 70d
Cleared Nov 13, 2003
BLUE SAIL (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K032781 · LYZ
Zibo Blue Sail Plastic & Rubber...
General Hospital · 66d
Cleared Nov 13, 2003
BLUE SAIL (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES
K032783 · LYZ
Zibo Blue Sail Plastic & Rubber...
General Hospital · 66d
Cleared Nov 13, 2003
HOSPITAL SPACER
K032809 · CAF
Respironics Healthscan, Inc.
Anesthesiology · 65d
Cleared Nov 13, 2003
STELKAST UNICONDYLAR KNEE SYSTEM
K032824 · HSX
Stelkast Company
Orthopedic · 64d
Cleared Nov 13, 2003
NAVIGATOR I
K032879 · INI
Adaptive Healthcare Technologies, Inc.
Physical Medicine · 59d
Cleared Nov 13, 2003
PREMISE
K032921 · EBF
Sybron Dental Specialties, Inc.
Dental · 52d
Cleared Nov 13, 2003
MPS ACACIA SAFEGUARD HUBER DEVICE
K032934 · FPA
Mps Acacia
General Hospital · 52d
Cleared Nov 13, 2003
EXACTECH 12/14 ALUMINA FEMORAL HEAD
K032964 · LPH
Exactech, Inc.
Orthopedic · 51d
Cleared Nov 13, 2003
DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES
K033144 · MKJ
Defibtech, LLC
Cardiovascular · 44d