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
59161–59184 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 13, 2007
BLUE MAX BALLOON DILATATION CATHETER
K071309 · LIT
Boston Scientific Corp
Cardiovascular · 65d
Cleared Jul 13, 2007
POWDER FREE LATEX EXAMINATION GLOVES
K071322 · LYY
Quality Gallant Sdn. Bhd.
General Hospital · 64d
Cleared Jul 13, 2007
MEPILEX AG DRESSING
K071354 · FRO
Monlycke Health Care
General & Plastic Surgery · 59d
Cleared Jul 13, 2007
TRELLIS-6 PERIPHERAL INFUSION SYSTEM
K071664 · QEY
Bacchus Vascular, Inc.
Cardiovascular · 25d
Cleared Jul 13, 2007
TRILOGY LONGEVITY CONSTRAINED LINER
K071718 · KWZ
Zimmer, Inc.
Orthopedic · 21d
Cleared Jul 13, 2007
ASAHI ASTATO 30 PERIPHERAL GUIDE WIRE, MODELS - PAGH18M071, PAGH18M371
K071721 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 18d
Cleared Jul 13, 2007
MODIFICATION TO: ENSEAL PTC TISSUE SEALING DEVICE
K071728 · GEI
Surgrx, Inc.
General & Plastic Surgery · 18d
Cleared Jul 12, 2007
HONEY ALGINATE DRESSING
K053095 · FRO
Derma Sciences Canada, Inc.
General & Plastic Surgery · 616d
Cleared Jul 12, 2007
DIGITAL PULSE OXIMETER, MODEL 7500
K071285 · DQA
Nonin Medical, Inc.
Anesthesiology · 66d
Cleared Jul 12, 2007
MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2
K071473 · EOQ
Superdimension, Ltd.
Radiology · 44d
Cleared Jul 12, 2007
MODIFICATION TO:CONTOUR SE MICROSPHERES
K071634 · HCG
Boston Scientific Corp
Neurology · 27d
Cleared Jul 12, 2007
VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM
K071640 · NHC
Cook, Inc.
Neurology · 27d
Cleared Jul 11, 2007
AXYA SUTURE WELDING SYSTEM AND KIT
K070253 · GAT
Axya Medical, Inc.
General & Plastic Surgery · 166d
Cleared Jul 11, 2007
GIRAFFE AND PANDA WARMER
K070377 · FMT
Ohmeda Medical
General Hospital · 153d
Cleared Jul 11, 2007
ENDO-CHX
K070401 · KJJ
Essential Dental Systems, Inc.
Dental · 149d
Cleared Jul 11, 2007
CLINICAL THERMOMETER/MODEL ZSDT-XXXX DIGITAL THERMOMETER AND ZSET-XXX...
K070578 · FLL
Zen Strong Medical Technology Co., Ltd.
General Hospital · 132d
Cleared Jul 11, 2007
BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM, VERSION 6
K070611 · IYE
Nomos Corp.
Radiology · 128d
Cleared Jul 11, 2007
SOYEE PORTABLE X-RAY UNIT, MODEL SY-HF-110
K070634 · IZL
Soyee Product, Inc.
Radiology · 126d
Cleared Jul 11, 2007
DYNASTY ACETABULAR SYSTEM
K070785 · JDL
Wrightmedicaltechnologyinc
Orthopedic · 112d
Cleared Jul 11, 2007
ULTRAWAVE II EX 1320
K070805 · GEX
Quanta System Spa
General & Plastic Surgery · 110d
Cleared Jul 11, 2007
NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM
K070960 · CGA
Nova Biomedical Corp.
Chemistry · 97d
Cleared Jul 11, 2007
PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013
K071182 · ELL
Nobel Biocare AB
Dental · 72d
Cleared Jul 11, 2007
CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM,...
K071227 · PDU
Spectranetics Corp.
Cardiovascular · 69d
Cleared Jul 11, 2007
BACKPACK MEDICAL OXYGEN SYSTEM
K071581 · BYJ
Essex Cryogenics of Missouri, Inc.
Anesthesiology · 33d