11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VERTE-STACK SPINAL SYSTEM, EXTRA SMALL SIZES
FDA 510(k)
FDA Class 2
·Orthopedic
VERTE-STACK K030736, K041197
FDA Adverse Event
Death
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MQP·January 4, 2019
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120307361·Diamond, torpedo, medium grit
MRI LINE MARKER
FDA 510(k)
FDA Class 2
·Radiology
LA JOIE
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
MAVERICK2 MONORAIL PTCA CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code LOX·January 9, 2007
YALE NH TT VISION SYS GBS
FDA Adverse Event
Other
·GISH BIOMEDICAL, INC.·Product code OEZ·December 3, 2010
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 2, 2013
LCS COMPLETE M/B PAT POR STD+
FDA Adverse Event
Injury
·DEPUY (IRELAND)·Product code NJL·March 19, 2011
ILA 100-3.8 ANASTOMOTIC TITANIUM DLU
FDA Adverse Event
Injury
·PONCE - USS·Product code GAG·April 17, 2008
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