BEUDAMED
    307 results · 13ms · Sources: EU EUDAMED, US FDA

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    rHead Stem Implant 6mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Enforcement
    Class II ·Terminated·Howmedica Osteonics Corp.·August 15, 2018

    TCM CombiM Modules 903-111

    FDA Recall
    Terminated ·Radiometer America Inc·Product code LKD·November 18, 2015

    Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile.

    FDA Recall
    Terminated ·Halyard Health·Product code LZA·November 10, 2016

    Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, F1200 F180.

    FDA Recall
    Terminated ·Repro-Med Systems, Inc.·Product code FRN·March 10, 2016

    HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part Numbers RMS22606, RMS22609, RMS22612, RMS12606, RMS22409, RMS32609, RMS32609, RMS12409, RMS12609, RMS62612, RMS62606, RMS12406, RMS22412, RMS12412, RMS42606, RMS62609, RMS52612, RMS42612, RMS32609, RMS22609, RMS22606, RMS42609 & RMS32612.

    FDA Recall
    Terminated ·Repro-Med Systems, Inc.·Product code FPA·March 10, 2016

    The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code DQK·March 10, 2016

    Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173,

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code LLZ·May 9, 2016

    Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for use by clinical laboratories in the qualitative determination of barbiturates in oral fluids.

    FDA Recall
    Terminated ·OraSure Technologies, Inc.·Product code DIS·November 10, 2016

    The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the Dimension clinical chemistry system. For prescription use only.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JIT·May 5, 2016

    Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.

    FDA Recall
    Terminated ·Jas Diagnostics/Drew Scientific·Product code GKZ·March 10, 2016

    Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens

    FDA Recall
    Terminated ·Medtronic·Product code FEI·October 4, 2016

    The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate Aminotransferase (AST) methods on the Dimension Vista System. For prescription use only.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JIX·May 5, 2016

    Poly-bags containing splint strap labeled with "Pediatric" sticker. Each strap kit contains adjustable length leg straps, ankle wrap, a thigh pad and a heel stand. The strap kits are applied to the traction splint frame to immobilize and provide traction for a patients leg.

    FDA Recall
    Terminated ·Ferno-Washington Inc·Product code NZD·March 10, 2016

    Pediatric Craniotome

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code BWN·October 6, 2016

    Best Practices kits containing certain production lots of Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens

    FDA Recall
    Terminated ·Medtronic·Product code FEI·October 4, 2016

    Poly-bags containing the strap labeled with "Adult" sticker. Each strap kit contains adjustable length leg straps, ankle wrap, a thigh pad and a heel stand. The strap kits are applied to the traction splint frame to immobilize and provide traction for a patients leg.

    FDA Recall
    Terminated ·Ferno-Washington Inc·Product code NZD·March 10, 2016

    Foot Control, SC2100 Product Usage: Electric system

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code ERL·October 6, 2016

    Compact Speed Reducer, 60:1

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code BWN·October 6, 2016

    6.1CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code BWN·October 6, 2016

    Rotating Adult Craniotome Product Usage: Pneumatic system

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code BWN·October 6, 2016