12 results · 20ms · Sources: EU EUDAMED, US FDA

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MINIHIP STEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Cook

FDA UDI
COOK INCORPORATED·00827002167407·Cook Cystostomy Catheter Set

P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM)

FDA 510(k)
FDA Class 2 ·Orthopedic

CONTROL PLASMA P

FDA 510(k)
FDA Class 2 ·Hematology

ELECTROSURGICAL COAGULATION FOR AESTHETIC

FDA Adverse Event
Injury ·F CARE SYSTEMS USA LLC·Product code ONQ·November 22, 2013

TURBO-JECT® DOUBLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC

FDA Adverse Event
Injury ·COOK INC·Product code LJS·December 20, 2018

3000 ELECTRIC - 78"

FDA Adverse Event
Death ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 29, 2013

LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·April 13, 2011

COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUISON PUMP

FDA Adverse Event
Injury ·BAXTER HEALTHCARE PTE. LTD·Product code FRN·July 28, 2008

BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018