15 results · 21ms · Sources: EU EUDAMED, US FDA

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PICA WHOLE BODY MRI SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

Vilex Power Accessory

FDA UDI
VILEX IN TENNESSEE, INC.·00841731122186·KWire .035x6" (0.9x150mm)

NEUROVENT-PX

FDA UDI
RAUMEDIC AG·04057834088410·

Vilex Power Accessory

FDA UDI
VILEX IN TENNESSEE, INC.·00841731122179·KWire .035x6" (0.9x150mm) Threaded

SIMPLICITY SOFT QD SILVER INFUSION SET

FDA 510(k)
FDA Class 2 ·General Hospital

GROSS FEMORAL COMPONENT

FDA 510(k)
FDA Class 2 ·Orthopedic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 18, 2024

WALLFLEX ESOPHAGEAL

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 23, 2025

WALLFLEX ESOPHAGEAL

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 14, 2025

PANORAMA CENTRAL STATION

FDA Adverse Event
Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

MBT CEM KEEL TIB TRAY SZ2.5

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code NJL·September 16, 2014

GREENLIGHT ADDSTAT

FDA Adverse Event
Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·April 6, 2011

MESH ¿ COMPOSIX KUGEL

FDA Adverse Event
Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·April 19, 2023

NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL

FDA 510(k)
FDA Class 2 ·Neurology

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