19 results · 23ms · Sources: EU EUDAMED, US FDA

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SHOCKWAVE SUSPENSION WHEELCHAIR

FDA 510(k)
FDA Class 1 ·Physical Medicine

NIDOIL

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

BIOARC SP SLING KIT

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

BD INTIMA-II CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·July 15, 2021

SCP PANEL CENTRIFUGE JMS

FDA Adverse Event
Other ·SORIN GROUP DEUTSCHLAND·Product code DWA·November 5, 2013

SCP PANEL CENTRIFUGE JMS

FDA Adverse Event
Other ·SORIN GROUP DEUTSCHLAND·Product code DWA·March 14, 2014

SCP CONTROL PANEL

FDA Adverse Event
Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·January 5, 2012

CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND·Product code DWA·January 19, 2018

CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP

FDA Adverse Event
Malfunction ·LIVANOVA DEUTSCHLAND GMBH·Product code DWA·January 5, 2022

STOCKERT JMS CENTRIFUGAL PUMP SYSTEM

FDA Adverse Event
Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·January 5, 2012

TRI-LOCK BPS SZ 3 STD OFFSET

FDA Adverse Event
Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·April 3, 2013

CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code DYE·March 28, 2011

LIGASURE LAPAROSCOPIC SLR/DIV

FDA Adverse Event
Malfunction ·COVIDIEN LP, (US SURGICAL)·Product code GEI·April 16, 2008

STOCKERT CENTRIFUGAL PUMP (SCP) SYSTEM

FDA Adverse Event
Injury ·SORIN GROUP DEUTSCHLAND·Product code DWA·May 7, 2010

TI PANGEA LOCKING CAP

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code NKB·June 5, 2012

TI PANGEA LOCKING CAP

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code NKB·June 5, 2012

TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01

FDA Enforcement
Class II ·Terminated·ArthroCare Corporation·April 13, 2016

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

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