17 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PRECICE TRAUMA NAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Healthweigh
FDA UDI
Rice Lake Weighing Systems, Inc.·00850042373583·Scale, Wheelchair 350-10-3 1000lb(450kg) x 0.2l...
K2M General Instruments
FDA UDI
VB Spine LLC·10888857581425·Split Tube Retractor Ø22x90 mm
NUVASIVE ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ZIMMER PERIARTICULAR SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
FLOTATION CUSHION
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code KIC·July 20, 2012
FLOTATION CUSHION
FDA Adverse Event
Malfunction
·INVAMEX·Product code KIC·November 14, 2012
OT VERIO SYNC METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 4, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
ASR ACETABULAR IMPLANT 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·June 22, 2011
BD VIPER¿ LT SYSTEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code OOI·August 14, 2023
FLOTATION CUSHION
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code KIC·September 23, 2011
AXIUM
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019
AXIUM
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019
AXIUM
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 10, 2019
AXIUM
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·October 11, 2019
TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide a conduit for blood to travel from the patient s venous system when connected to accessory extracorporeal equipment. The Venous Cannula is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.
FDA Enforcement
Class II
·Terminated·Cardiac Assist, Inc·February 19, 2020