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

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176,076 results
64633–64656 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 13, 2005
DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT
K052755 · DQA
Ge Healthcare
Anesthesiology · 13d
Cleared Oct 12, 2005
ENTERAL FEEDING TUBE
K051480 · BSS
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 131d
Cleared Oct 12, 2005
AUTOCHECK6+
K051928 · JJY
Radiometer Medical Aps
Chemistry · 86d
Cleared Oct 12, 2005
NV CORMED SOLAS SPINAL SYSTEM
K051959 · MNH
Nv Cormed
Orthopedic · 86d
Cleared Oct 12, 2005
SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS
K051977 · JWH
Howmedica Osteonics Corp.
Orthopedic · 83d
Cleared Oct 12, 2005
NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A
K052497 · MOS
Invivo Corp.
Radiology · 30d
Cleared Oct 12, 2005
SELECTFLOW - INTRAVASCULAR ADMINISTRATION SET
K052658 · FPA
Renascence Medical, Inc.
General Hospital · 15d
Cleared Oct 12, 2005
SYNTHES UNIVERSAL LOCKING TROCHANTER STABILIZATION PLATE (ULTSP)
K052677 · HRS
Synthes (Usa)
Orthopedic · 14d
Cleared Oct 11, 2005
UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS
K050373 · HSX
Arthrosurface, Inc.
Orthopedic · 239d
Cleared Oct 11, 2005
DYNATRON DX2 TRACTION UNIT
K051680 · ILY
Dynatronics Corp.
Physical Medicine · 110d
Cleared Oct 11, 2005
COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A
K051912 · NCX
Alsius Corp.
Neurology · 89d
Cleared Oct 11, 2005
VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15)
K052003 · GEI
Vnus Medical Technologies, Inc.
General & Plastic Surgery · 78d
Cleared Oct 11, 2005
ADVIA IMS GLUCOSE ASSAY
K052163 · CFR
Bayer Healthcare, LLC
Chemistry · 63d
Cleared Oct 11, 2005
COOK IRELAND ECHOBRUSH
K052279 · FDX
Cook Ireland, Ltd.
Gastroenterology & Urology · 50d
Cleared Oct 11, 2005
SPECTRAQUATTRO PULSED LIGHT SYSTEM
K052336 · GEX
Amjet Distribution, LLC
General & Plastic Surgery · 46d
Cleared Oct 11, 2005
MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER
K052440 · EZD
Mentor Corporation
Gastroenterology & Urology · 35d
Cleared Oct 11, 2005
ATRILAZE MALLEABLE ABLATION PROBE
K052495 · GEX
Medical Cv, Inc.
General & Plastic Surgery · 29d
Cleared Oct 11, 2005
AOC BONE WAX OSTENE, OSTEOTENE AND CERETENE
K052528 · MTJ
Ceremed , Inc.
General & Plastic Surgery · 27d
Cleared Oct 11, 2005
TEH LOONG POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE
K052634 · LYZ
Teh Loong Corp.
General Hospital · 15d
Cleared Oct 11, 2005
MODIFICATION TO: XIA 4.5 SPINAL SYSTEM
K052761 · MNI
Stryker Spine
Orthopedic · 11d
Cleared Oct 07, 2005
GLUCODR SUPERSENSOR SYSTEM
K050985 · NBW
All Medicus Co., Ltd.
Chemistry · 171d
Cleared Oct 07, 2005
EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE
K050997 · MQP
Flexuspine, Inc.
Orthopedic · 170d
Cleared Oct 07, 2005
ARCTEC SEMIRIGID PLATING SYSTEM
K051044 · MNH
Altiva Corp.
Orthopedic · 165d
Cleared Oct 07, 2005
THERATEST EL-ANA PROFILES
K051066 · LKP
Theratest Laboratories, Inc.
Immunology · 164d