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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
55393–55416 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 09, 2008
PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION
K082330 · FRO
Primary Care Solutions, Inc.
General & Plastic Surgery · 56d
Cleared Oct 09, 2008
UltraClot, UltraClot OTC
K082601 · QSY
Emergency Medical Devices, LLC
General & Plastic Surgery · 31d
Cleared Oct 09, 2008
MIPUMP SINGLE ELECTRIC/BATTERY BREAT PUMP & MIPUMP DOUBLE ELECTRIC/BATTERY...
K082802 · HGX
Learning Curve Brands Inc. the First...
Obstetrics & Gynecology · 15d
Cleared Oct 08, 2008
BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE,...
K081187 · DQX
Bridgepoint Medical
Cardiovascular · 163d
Cleared Oct 08, 2008
MAYFIELD MR/X-RAY SKULL CLAMP
K081401 · HBL
Integra Lifesciences Corp.
Neurology · 142d
Cleared Oct 08, 2008
FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO
K081447 · BSZ
Draeger Medical AG & Co. KG
Anesthesiology · 139d
Cleared Oct 08, 2008
VITRECTOMY CUTTER AND ACCESSORIES
K081681 · MLZ
Advanced Medical Optics, Inc.
Ophthalmic · 113d
Cleared Oct 08, 2008
MAJOR.BASE 20
K081884 · EBI
Major Prodotti Dentari S.P.A.
Dental · 98d
Cleared Oct 08, 2008
POWERLIPO LASER SYSTEM
K082096 · GEX
Lutronic Corporation
General & Plastic Surgery · 76d
Cleared Oct 08, 2008
LTM WOUND DRESSING
K082103 · KGN
Lifecell Corp.
General & Plastic Surgery · 75d
Cleared Oct 08, 2008
HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B
K082202 · GEI
Barrx Medical, Incorporated
General & Plastic Surgery · 64d
Cleared Oct 08, 2008
S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE...
K082229 · IYO
Volcano Corporation
Radiology · 62d
Cleared Oct 08, 2008
ICON, MODEL C3
K082242 · DSB
Osypka Medical, Inc.
Cardiovascular · 62d
Cleared Oct 08, 2008
EVIS MD PLATINUM RED LIGHT THERAPY
K082247 · GEX
Ageless Beauty Corporation
General & Plastic Surgery · 61d
Cleared Oct 08, 2008
SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR, SURESIGNS...
K082280 · MHX
Philips Medical Systems North America...
Cardiovascular · 58d
Cleared Oct 08, 2008
EXSUDEX WOUND DRAINAGE PUMP
K082311 · OMP
The Medical Company
General & Plastic Surgery · 56d
Cleared Oct 08, 2008
ZONARE ULTRA ULTRASOUND SYSTEM
K082326 · IYN
Zonare Medical Systems, Inc.
Radiology · 55d
Cleared Oct 08, 2008
TRACHEOSCOPIC VENTILATION TUBE (TVT)
K082420 · BTR
Etview
Anesthesiology · 47d
Cleared Oct 08, 2008
GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE
K082486 · NBW
Bayer Healthcare, LLC
Chemistry · 41d
Cleared Oct 08, 2008
LDR SPINE EASYSPINE SYSTEM
K082592 · NKB
Ldr Spine USA
Orthopedic · 30d
Cleared Oct 08, 2008
RTX RESPIRATOR
K082657 · BYT
Medivent Limited
Anesthesiology · 26d
Cleared Oct 08, 2008
GE LIGHTSPEED 7.2 CT SCANNER SYSTEM
K082761 · JAK
Ge Medical Systems, LLC
Radiology · 16d
Cleared Oct 08, 2008
WELL LEAD SILICONE AND LATEX FOLEY CATHETERS
K082815 · EZL
Well Lead Medical Instruments
Gastroenterology & Urology · 13d
Cleared Oct 08, 2008
GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM
K082816 · JAK
Ge Medical Systems, LLC
Radiology · 13d