15 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO: ERBE APC CONNECTOR HOSE AND PROBES, MODELS 20132-158, 20132-155, 20132-156, 20132-157, 20132-166
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Natus
FDA UDI
XLTEK·00382830016384·Natus Quantum Breakout to Base Cable, 33 ft (10m)
GEL-FILLED MAMMARY PROSTHESIS
FDA Adverse Event
Injury
·AMERICAN HEYER-SCHULTE·Product code FTR·April 17, 1998
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033478479·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033478462·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033478455·
EZ2C
FDA UDI
FGX INTERNATIONAL INC.·00193033478486·
TANTALUM BEADS - RADIOGRAPHIC MARKER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
E.N.S.I. RETRACTABLE SAFETY SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
LOGIC CR TIB INSERT STD, SZ 5, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·November 22, 2023
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·March 20, 2013
SHILEY DISPOSABLE CANNULA LOW PRESSURE
FDA Adverse Event
Injury
·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code JOH·March 8, 2011
GDC 10-SOFT 2D SR / 2-DIAMETER STRETCH RES.
FDA Adverse Event
Injury
·NEUROVASCULAR, A DIV OF BOSTON SCIENTIFIC CORP.·Product code HCG·March 13, 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
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014