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
64105–64128 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 2005
TEH LOONG POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW
K052635 · LYZ
Teh Loong Corp.
General Hospital · 78d
Cleared Dec 13, 2005
COROLENE
K052701 · GAW
Peters Surgical
General & Plastic Surgery · 76d
Cleared Dec 13, 2005
TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS...
K052776 · HTN
Arthrex, Inc.
Orthopedic · 71d
Cleared Dec 13, 2005
OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER
K052866 · CBF
Oxyheal Health Group
Anesthesiology · 63d
Cleared Dec 13, 2005
PRO-FLOW MULTIPURPOSE CANNULA
K053063 · CCK
Pro-Tech Services, Inc.
Anesthesiology · 42d
Cleared Dec 13, 2005
SPIRO-BALL
K053149 · BWF
Leventon, S.A.
Anesthesiology · 33d
Cleared Dec 13, 2005
ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP
K053282 · GEI
Pajunk GmbH
General & Plastic Surgery · 18d
Cleared Dec 13, 2005
MODIFICATION TO THERMAGE THERMACOOL SYSTEM
K053365 · GEI
Thermage, Inc.
General & Plastic Surgery · 11d
Cleared Dec 12, 2005
T-TEK
K050817 · GJA
R2 Diagnostics, Inc.
Hematology · 256d
Cleared Dec 12, 2005
EASYSTIM NMS-28
K050921 · IPF
Easy Med Instrument Co., Ltd.
Physical Medicine · 243d
Cleared Dec 12, 2005
LIMERICK PJ'S COMFORT JR PORTABLE ELECTRIC BREAST PUMP
K051926 · HGX
Limerick, Inc.
Obstetrics & Gynecology · 147d
Cleared Dec 12, 2005
IMMUNOSCAN RA ANTI-CCP TEST SYSTEM
K052133 · NHX
Eurodiagnostica
Immunology · 129d
Cleared Dec 12, 2005
NUVASIVE COROENT EXTENSURE SYSTEM
K052210 · MQP
Nuvasive, Inc.
Orthopedic · 119d
Cleared Dec 12, 2005
ELLIPSE FLEX PPT, MODEL 9ESF7255
K052688 · GEX
Danish Dermatologic Development A/S
General & Plastic Surgery · 75d
Cleared Dec 12, 2005
CAPLESS PEDICLE SCREW SYSTEM
K052847 · MNI
X-Spine Systems, Inc.
Orthopedic · 66d
Cleared Dec 12, 2005
ARTHREX TENSIONLOK
K052901 · HRS
Arthrex, Inc.
Orthopedic · 59d
Cleared Dec 12, 2005
ORTHOFIX TITANIUM NAILING SYSTEMS
K053261 · HSB
Orthofix Srl
Orthopedic · 20d
Cleared Dec 09, 2005
FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300
K050933 · NCR
Medisurg , Ltd.
Ophthalmic · 239d
Cleared Dec 09, 2005
LAGUNA MONOAXIAL PEDICLE SCREW SYSTEM
K051275 · NKB
Allez Spine, LLC
Orthopedic · 206d
Cleared Dec 09, 2005
CRONUS GUIDEWIRE, MODEL 001-001470-1
K051373 · NDQ
Stereotaxis, Inc.
Neurology · 197d
Cleared Dec 09, 2005
GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H
K051520 · KDI
Gambro Renal Products
Gastroenterology & Urology · 184d
Cleared Dec 09, 2005
MINIMATE COMPRESSOR
K051691 · BTI
Precision Medical, Inc.
Anesthesiology · 169d
Cleared Dec 09, 2005
POWDER FREE STERILE LATEX SURGICAL GLOVES
K052177 · KGO
Hartalega Sdn Bhd
General Hospital · 121d
Cleared Dec 09, 2005
GLUCOSE PILOT
K052208 · NBW
Tianjin New Bay Bioresearch Co., Ltd.
Chemistry · 119d