21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DEPUY CAS KNEE INSTRUMENTATION
FDA 510(k)
FDA Class 2
·Neurology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814268·GENUMEDI PT SILVER R III
n/a
FDA UDI
Ortho Development Corporation·00822409074228·10/12 Broach 12x23
Symmetry Nelson-Metzenbaum
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482147221·Symmetry® Scissors, Nelson Metzenbaum Dissectin...
HNM Medical
FDA UDI
HNM STAINLESS, LLC.·00842962107461·NELSON METZENBAUM DISSECTING SCISSORS, 9", STR
GEON DIGITAL CLINICAL THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM (PVOCS)
FDA 510(k)
FDA Class 2
·Anesthesiology
CP840442 DE LEIPZIG
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·May 12, 2010
CP025369 DE LEIPZIG
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·August 3, 2011
CP85315 IT MODENA
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·January 14, 2013
CP84050 FR LA REUNION
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·May 17, 2012
CP84042 DE LEIPZIG %
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DWE·April 20, 2011
D905 DIDECO EOS SINGLE HVR
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·September 25, 2013
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·April 9, 2013
BV PULSERA, REL. 2.3
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code IZL·February 24, 2011
VITALITY AVT
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA 510 K042396 Used in several T2 systems intended to support the exchange of the Ball Tip Guide Wires for Smooth Tip Guide Wires: T2 Tibial Nailing Systems, T2 Femoral Nailing Systems, T2 Ankle Nailing Systems, and T2 Humerus Nailing Systems
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·February 5, 2014
D905 EOS OXYGENATOR (PHISIO TREATED)
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·July 13, 2018
D905 EOS PHISIO OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L.·Product code DTZ·August 8, 2017
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