21 results
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19ms
·
Sources: EU EUDAMED, US FDA
EBI VUECATH SPINAL ENDOSCOPIC SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Endo Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964055353·Endo Carry-on Procedure Kit Includes Basin, Int...
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036006815·
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0101090·Distractor, Smooth Paddle, Lordotic, 9mm
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033104538·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033104491·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033104507·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033104484·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033104521·
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0101090·Distractor, Smooth Paddle, 9mm
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033104514·
Biosteon® Screw
FDA UDI
BIOCOMPOSITES LTD·15060155710331·The Biosteon® ACL Screw is a cannulated single-...
NUZONE NITRILE SURGICAL GLOVES POWDER FREE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SUPER NOVA, ACUBEAM
FDA 510(k)
FDA Class 2
·Physical Medicine
BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·October 10, 2022
2520274-2013-01567
FDA Adverse Event
Injury
·SYNTHES USA·Product code HSB·March 19, 2013
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·March 1, 2011
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·March 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
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013