19 results
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30ms
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Sources: EU EUDAMED, US FDA
DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY
FDA 510(k)
FDA Class 2
·Orthopedic
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70611311·Micro Sprint-Brackets .022" Easytwin Micro Open...
3D HDRAULIC FINE MICROMANIPULATOR MO-188NE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
METHADONE MICROPLATE EIA URINE APPLICATION
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ENDOPATH ETS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·November 7, 1997
RU NOVOSIBIRSK
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·October 16, 2013
ST JOSEPHS PHOENIX, AZ 1
FDA Adverse Event
Malfunction
·SORIN GROUP USA·Product code DWF·July 31, 2009
RU NOVOSIBRIRSK
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·April 11, 2013
RU NOVOSIBIRSK
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DWF·October 16, 2013
CP87170 DE MUENCHEN
FDA Adverse Event
Death
·SORIN GROUP ITALIA·Product code DTZ·July 15, 2011
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code OSI·April 16, 2013
MICROCAPS ARTHROWAND
FDA Adverse Event
Other
·ARTHROCARE CORP.·Product code GEI·June 18, 2008
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 18, 2011
CP87641 GB SOUTHAMPTON
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DWE·March 22, 2010
SITE-RITE 8 ULTRASOUND SYSTEM 20MM PINPOINT GT PROBE (REMANUFACTURED)
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (BASD) -3006260740·Product code IYO·November 9, 2022
ENDOPATH ETS FLEX
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·February 6, 1998
D 100 PH.I.S.I.O. NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH RESERVOIR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L.·Product code DTZ·March 28, 2017
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
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