14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY
FDA 510(k)
FDA Class 3
·Orthopedic
ZIMMER M/L TAPER FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER INC·Product code LZO·February 17, 2016
KINECTIV MODULAR NECK
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code KWA·May 26, 2016
Sklar®
FDA UDI
SKLAR CORPORATION·10649111202797·DEJERINE HAMMER 8"
SPIRIT 300
FDA 510(k)
FDA Class 2
·Anesthesiology
BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690
FDA 510(k)
FDA Class 2
·Anesthesiology
CP87170 DE MUENCHEN
FDA Adverse Event
Death
·SORIN GROUP ITALIA·Product code DTZ·July 15, 2011
ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT
FDA Adverse Event
Malfunction
·DENTSPLY PROFESSIONAL·Product code EKX·February 26, 2013
PRESERVATION UNI FEM CEM SZ2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, DEPUY-CORK·Product code HRY·June 18, 2008
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 19, 2011
TORQUE LIMITING HANDLE/QUICK RELEASE-6MM HEX COUPLING
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·July 9, 2020
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
Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November 2011 and March 2012. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using the IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·October 25, 2017
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015