11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UNITED U2 PATELLA
FDA 510(k)
FDA Class 2
·Orthopedic
IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)
FDA 510(k)
FDA Class 1
·Dental
RESORBABLE NO PROFILE SCREW AND WASHER
FDA 510(k)
FDA Class 2
·Orthopedic
PASS LP
FDA Adverse Event
MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·April 5, 2012
PASS LP
FDA Adverse Event
Injury
·MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013
HEARTMATE II SYSTEM CONTROLLER
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·April 25, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·May 10, 2011
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·July 22, 2008
1.5MM DIA DRILL BIT W/6MM STOP 13MM LENGTH F/90° SCREWDRIVER
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code DZI·May 19, 2015
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