11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD
FDA 510(k)
FDA Class 2
·Cardiovascular
LIQUICHEK LIPIDS CONTROL, MODEL 641, 642
FDA 510(k)
FDA Class 1
·Clinical Chemistry
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 5, 2014
QUATTRODE LEAD WIDE SPACED, 30 CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 8, 2015
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·April 23, 2013
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 8, 2011
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008
Vanguard XP Tibial Tray 83 mm Item # 195253
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
KINETRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·November 22, 2013
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