13 results
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19ms
·
Sources: EU EUDAMED, US FDA
ABBOTT AXSYM TROPONIN-I ADV
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SOAR Retractor System
FDA UDI
SPINEOLOGY INC.·M7403041811·18mm x 110mm Portal Tube
NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MONARCH INFLATION SYRINGE; UNIVERSAL FLUID DISPENSING SYRINGE
FDA 510(k)
FDA Class 2
·Cardiovascular
COVER, BURR HOLE
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code GXR·July 1, 2016
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 8, 2013
ENDOTAK ENDURANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 6, 2011
VITALITY AVT FAST-CHARGE
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
M-LNCS Y-I
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·August 12, 2017
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·September 22, 2016
IBC INTERNATIONAL BIOPHYSICS CORP. 2101-2 EAST ST. ELMO, SUITE 275, AUSTIN, TX 78744 SUCTION HANDLE (STERILE) PART NUMBER: 1990S LOT NUMBER 041811-2065 EXPIRATION DATE: 18/APR/2015 For use in open heart procedures, Autologus blood recovery or blood suction. Product is a component of Blood Recovery Systems.
FDA Recall
Terminated
·International Biophysics Corp·Product code DTS·October 5, 2011
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