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
65425–65448 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 15, 2005
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (WHITE, YELLOW)
K051723 · LYZ
Zibo Sinocare Plastic Products Co., Ltd.
General Hospital · 18d
Cleared Jul 15, 2005
TSX-101A/H AQUILION 64 SP CT SCANNER
K051833 · JAK
Toshiba America Medical Systems, In.C
Radiology · 9d
Cleared Jul 14, 2005
HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ),...
K050410 · IMI
Hwang Sun Enterprise Co., Ltd.
Physical Medicine · 147d
Cleared Jul 14, 2005
READMYHEART, MODEL RMH3.0
K050620 · DPS
Dailycare Biomedical, Inc.
Cardiovascular · 126d
Cleared Jul 14, 2005
TORNIER ELBOW PROSTHESIS
K050848 · JDB
Tornier
Orthopedic · 101d
Cleared Jul 14, 2005
CONMED IRRIGATION NOZZLE
K050992 · KPL
Conmedcorp
Gastroenterology & Urology · 86d
Cleared Jul 14, 2005
19-INCH (48CM) COLOR LCD MONITOR CDL1904A
K051403 · LLZ
Totoku Electric Co., Ltd.
Radiology · 44d
Cleared Jul 14, 2005
FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS
K051446 · HIL
First Quality Hygienic, Inc.
Obstetrics & Gynecology · 42d
Cleared Jul 14, 2005
POWERMAX 25, MODEL PM25
K051547 · ELC
Tpc Advanced Technology, Inc.
Dental · 31d
Cleared Jul 14, 2005
BARRIER SURGICAL DRAPES
K051625 · KKX
Molnlycke Health Care, Inc.
General Hospital · 24d
Cleared Jul 14, 2005
ILAB ULTRASOUND IMAGING SYSTEM
K051679 · OBJ
Boston Scientific Corp
Cardiovascular · 21d
Cleared Jul 14, 2005
CARDIOMEM CM 3000-12
K051686 · MWJ
Getemed Medizin- Und...
Cardiovascular · 21d
Cleared Jul 14, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMOXICILLIN (STREP) 0.0313 - 32 UG/ML
K051692 · LON
Becton, Dickinson & CO
Microbiology · 21d
Cleared Jul 14, 2005
ECHOSYSTEM
K051745 · LLZ
Medstrat, Inc.
Radiology · 15d
Cleared Jul 14, 2005
QD KNEE/FOOT COIL, MODEL MJQJ-147A
K051763 · MOS
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Jul 14, 2005
CERETOM, MODEL NL3000
K051765 · JAK
Neurologica Corporation
Radiology · 14d
Cleared Jul 14, 2005
NOMAD DENTAL X-RAY SYSTEM
K051795 · EHD
Aribex, Inc.
Radiology · 9d
Cleared Jul 13, 2005
K-C HEMOSTATIC BIOPSY SYSTEM
K050135 · FCG
Bioengineering Consultants , Ltd.
Gastroenterology & Urology · 173d
Cleared Jul 13, 2005
3TEST GLUCOSE MONITORING SYSTEM
K050224 · NBW
Neuero Engineering, Inc.
Chemistry · 163d
Cleared Jul 13, 2005
CS MEDICAL TTCF GAS DELIVERY SYSTEM
K050381 · BZR
Cs Medical, Inc.
Anesthesiology · 148d
Cleared Jul 13, 2005
IMPEDIMED - BODY COMPOSITION ANALYSIS
K050395 · MNW
Impedimed Pty , Ltd.
Gastroenterology & Urology · 147d
Cleared Jul 13, 2005
TISSU-TRANS
K050797 · KYZ
Shippert Medical Technologies Corp.
General Hospital · 106d
Cleared Jul 13, 2005
SYNTHES (USA) LOW-PROFILE WRIST FIXATOR
K051049 · KTT
Synthes (Usa)
Orthopedic · 79d
Cleared Jul 13, 2005
ANGIODYNAMICS TUMESCENT INFUSION DEVICE
K051142 · FPA
AngioDynamics, Inc.
General Hospital · 70d