16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM
FDA 510(k)
FDA Class 2
·Dental
BIO-RAD %CDT TIA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MODIFICATION TO CERASORB ORTHO
FDA 510(k)
FDA Class 2
·Orthopedic
AVALIGN
FDA Adverse Event
Malfunction
·AVALIGN GERMAN SPECIALTY INSTRUMENTS·Product code HAE·June 17, 2019
COVER, BURR HOLE
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code GXR·July 1, 2016
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 8, 2013
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 6, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE EF 14 MM THICKNESS
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·August 3, 2018
TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE EF 14 MM THICKNESS
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·August 3, 2018
TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE GH 14 MM THICKNESS
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·August 3, 2018
TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE GH 11 MM THICKNESS
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·August 3, 2018
TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE EF 14 MM THICKNESS
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·August 3, 2018
TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE GH 11 MM THICKNESS
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·August 3, 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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018