16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Dental
MATRIXNEURO STERILE KIT STD 4
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code JEY·December 19, 2013
TI MATRIXNEURO BURR HOLE COVER24MM
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code JEY·October 28, 2015
MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 1U I/C
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·June 23, 2013
MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code JEY·August 28, 2015
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496042365·ALISEA 70, SIZE XL, PRUGNA, GRADUATED COMPRESSI...
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809872729·FOR MEN 15-20 MM HG THIGH MICRO DOT BAND CLOSED...
DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET
FDA 510(k)
FDA Class 2
·Cardiovascular
VAXCEL DIALYSIS CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PLATE, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HRS·January 21, 2016
NEUROMONITOR BASIC KIT
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code GWM·January 13, 2023
6.5 CM ADULT CRANI ATTACHMENT
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·April 3, 2013
ACUITY
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·April 6, 2011
VITALITY DS
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
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