19 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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