15 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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XIOS PLUS WALL-MODULE
FDA 510(k)
FDA Class 2
·Dental
OsteoMed
FDA UDI
OSTEOMED LLC·00845694038911·1.9mm x 3mm Safety Screw
CABLE,INTERFACE,1/4-1/4",30'
FDA UDI
Datascope Corp.·10607567113807·
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 30, 2019
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 16, 2021
LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE
FDA 510(k)
FDA Class 2
·Cardiovascular
NEOCONTROL PELVIC FLOOR THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VERCISE CARTESIA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·November 10, 2023
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 5, 2011
SM104 MSERIES W5TH WHLOBS3/07
FDA Adverse Event
STRYKER CORP - MEDICAL DIV·Product code FPO·July 25, 2008
BD PEGASUS YEL 24GA X 0.75IN QSYTE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·December 5, 2023
Polyflex Esophageal Stent 20/16mm x 120mm
FDA Recall
Terminated
·Boston Scientific Corporation·Product code ESW·April 16, 2003
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
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 9, 2016