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.

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

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175,820 results
48553–48576 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 10, 2011
AVAMAX VERTEBRAL BALLOON
K103064 · NDN
Care Fusion
Orthopedic · 84d
Cleared Jan 10, 2011
MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM)...
K103110 · LOX
Abbott Vascular-Cardiac Therapies
Cardiovascular · 94d
Cleared Jan 10, 2011
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+)
K103209 · OCC
Nanosphere, Inc.
Microbiology · 70d
Cleared Jan 10, 2011
CAMLOG VARIO SR ABUTMENTS
K103252 · NHA
Altatec GmbH
Dental · 68d
Cleared Jan 07, 2011
OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561
K093280 · CHL
Opti Medical Systems, Inc.
Chemistry · 444d
Cleared Jan 07, 2011
ON CALL PLUS DIABETES MONITORING SOFTWARE
K101371 · NBW
ACON Laboratories, Inc.
Chemistry · 235d
Cleared Jan 07, 2011
ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL
K101588 · OVE
Apollo Spine, Inc.
Orthopedic · 214d
Cleared Jan 07, 2011
RPC E-Z CHEK 6.8-8.5 PH TEST STRIPS, MODEL K100-0117 AND E-Z CHEK 0-14 PH...
K101750 · MNV
Reprocessing Products Corp
Gastroenterology & Urology · 199d
Cleared Jan 07, 2011
ARTHREX SWIVELOCK ANCHORS
K101823 · MAI
Arthrex, Inc.
Orthopedic · 191d
Cleared Jan 07, 2011
SMDIA-1000
K101953 · CAF
Southmedic, Inc.
Anesthesiology · 179d
Cleared Jan 07, 2011
MEDPOR CONTAIN CAN IMPLANT
K102184 · NPK
Porex Surgical, Inc.
Dental · 158d
Cleared Jan 07, 2011
TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORTHOCORD, TRANSTEND...
K102298 · HWC
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 147d
Cleared Jan 07, 2011
BREEZE C MODEL C (3W), BREEZE C (4W)
K102304 · INI
Afikim Electric Vehicles
Physical Medicine · 144d
Cleared Jan 07, 2011
STINGRAY CERVICAL CAGE
K102322 · MAX
Omni Surgical, L.P.
Orthopedic · 143d
Cleared Jan 07, 2011
EVOLUTION MP TOTAL KNEE SYSTEM
K102380 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 137d
Cleared Jan 07, 2011
DISPOSABLE BLOOD PRESSURE CUFF
K102823 · DXQ
Wuxi Medical Instrument Factory
Cardiovascular · 100d
Cleared Jan 07, 2011
COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH
K103043 · EZD
Adapta Medical, Inc.
Gastroenterology & Urology · 85d
Cleared Jan 07, 2011
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K103117 · JWH
Conformis, Inc.
Orthopedic · 78d
Cleared Jan 07, 2011
6250 ULTRASOUND SYTEMS
K103152 · IYN
Esaote, S.P.A.
Radiology · 73d
Cleared Jan 07, 2011
HOSPIRA PLUM INFUSION SET
K103224 · FPA
Hospira, Inc.
General Hospital · 67d
Cleared Jan 07, 2011
BACKSTOP CATHETER
K103349 · KOD
Pluromed, Inc.
Gastroenterology & Urology · 52d
Cleared Jan 07, 2011
ELECSYS DHEA-S CALCHECK 5
K103402 · JJX
Roche Diagnostics
Chemistry · 49d
Cleared Jan 07, 2011
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
K103512 · IZH
Hologic, Inc.
Radiology · 38d
Cleared Jan 07, 2011
INTELLIVUE MX40 PATIENT MONITOR
K103646 · MHX
Phillips Medical Systems
Cardiovascular · 24d