18 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT
FDA 510(k)
FDA Class 2
·Cardiovascular
Rutner
FDA UDI
COOK INCORPORATED·00827002145399·Rutner Balloon Dilation Helical Stone Extractor
STEVE MADDEN
FDA UDI
FGX INTERNATIONAL INC.·00193033471210·
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361012375·PedFuse Remind LES, Quad, 5.5mm x 50mm
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0132000·Rod Reducer, Axial, NIDO
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132100·Trial, TLIF, 27L OB CRV 7Deg, 10mm
NA
FDA UDI
STRYKER CORPORATION·04546540346131·5.0mm XX-Coarse Diamond Round Extended
FMP METAL/METAL ACETABULAR INSERT
FDA 510(k)
FDA Class 3
·Orthopedic
TETRIC CERAM HB
FDA 510(k)
FDA Class 2
·Dental
BOM 7MM EXTENDED LENGTH ENDOSCOPE
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GCJ·March 27, 2019
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·March 20, 2013
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code NIQ·March 10, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 12, 2008
UNK BACTISEAL EVD CATHETER
FDA Adverse Event
Injury
·Product code JXG·November 21, 2017
ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients
FDA Enforcement
Class II
·Terminated·Teleflex Medical·December 7, 2016
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019