13 results · 29ms · Sources: EU EUDAMED, US FDA

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SURGICRAFT SURGICAL MESH SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Closed Wound Suction

FDA UDI
C. R. Bard, Inc.·00801741050015·100cc Silicone Closed Wound Suction Evacuator K...

NOBELACTIVE INTERNAL NP 3.5X11.5MM

FDA Adverse Event
Injury ·NOBEL BIOCARE AB·Product code DZE·August 13, 2020

NOBELACTIVE INTERNAL RP 4.3X10MM

FDA Adverse Event
Injury ·NOBEL BIOCARE USA INC·Product code DZE·September 8, 2020

NOBELACTIVE INTERNAL NP 3.5X11.5MM

FDA Adverse Event
Injury ·NOBEL BIOCARE AB·Product code DZE·August 13, 2020

SOLARA JR. MANUAL WHEELCHAIR

FDA 510(k)
FDA Class 1 ·Physical Medicine

FRAMELOCK; FRAMELOCK ACCESSORIES

FDA 510(k)
FDA Class 2 ·Neurology

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 1, 2020

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 27, 2025

HEARTMATE II LVAD

FDA Adverse Event
Injury ·THORATEC CORP.·Product code DSQ·April 19, 2013

ARCHITECT HAVAB IGM REAGENT

FDA Adverse Event
Malfunction ·ABBOTT·Product code LOL·April 29, 2011

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 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