19 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ASAHI Fielder XT-A, ASAHI Fielder XT-R
FDA 510(k)
FDA Class 2
·Cardiovascular
New Image
FDA UDI
HOLLISTER INCORPORATED·00610075078677·2-Piece Ostomy Skin Barrier, Convex, CeraPlus
Column, Desiccator, Disposable, 7 In
FDA UDI
A-M SYSTEMS, LLC·00817081026092·Column, Desiccator, Disposable, 7 In, Flon Mark...
Rectal Applicator
FDA UDI
Nucletron B.V.·08717213060746·
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100295·FRANKEL INFANT EYE SPECULUM
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197496070·RZ Rainer Ring Curettes
angled...
CHLORASHIELD TM ANTIMICROBIAL DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
TEGO, MODEL D1000
FDA 510(k)
FDA Class 2
·General Hospital
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DXY·June 8, 2013
QUATTRODE LEAD WIDE SPACED, 30 CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 23, 2011
CRYSTALENS
FDA Adverse Event
Injury
·EYEONICS, INC.·Product code HQL·September 8, 2008
ActiveLife One-Piece Pre-Cut Closed End (ostomy) Pouch with skin barrier and filter 45mm (box of 15) 1 3/4 in. 45 mm
FDA Recall
Terminated
·ConvaTec·Product code LNO·July 31, 2006
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 26, 2015
RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014
The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 10, 2014
Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 12, 2015
IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
FDA Enforcement
Class II
·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012