17 results · 37ms · Sources: EU EUDAMED, US FDA

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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