17 results
·
37ms
·
Sources: EU EUDAMED, US FDA
NOBEL BIOCARE ENDOSSEOUS IMPLANTS
FDA 510(k)
FDA Class 2
·Dental
RINGLOC CONSTRAINED LINERS
FDA 510(k)
FDA Class 2
·Orthopedic
CONCORD 88
FDA 510(k)
FDA Class 2
·Dental
COVER, BURR HOLE
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code GXR·July 1, 2016
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 8, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·March 10, 2011
ENDOTAK RELIANCE G
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·February 12, 2010
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 14 MM THICKNESS
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·August 3, 2018
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
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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