15 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH DESENSITIZING LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Tischler Biopsy Punch Blue Titanium
FDA UDI
MEDGYN PRODUCTS, INC.·M803030176·Tischler Biopsy Punch Blue Titanium 10" (254mm)...
TELECTRONICS 030176
FDA Adverse Event
Injury
·TELECTRONICS PACING SYSTEMS·Product code DTB·January 24, 1997
CALEX CONDITIONER
FDA 510(k)
FDA Class 2
·Dental
BIOEMG II AND BIOJVA
FDA 510(k)
FDA Class 2
·Physical Medicine
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 17, 2012
PROMUS ELEMENT ?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·April 2, 2013
DUROM ACETABULAR COMPONENT
FDA Adverse Event
Other
·ZIMMER GMBH·Product code KWA·March 15, 2011
SURGICAL FIBER
FDA Adverse Event
Injury
·LUMENIS, LTD. YOKNEAM·Product code GEX·April 8, 2008
SUPER TURBOVAC 90 IFS
FDA Adverse Event
Malfunction
·ARTHROCARE CORP.·Product code GEI·July 8, 2020
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013