13 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES
FDA 510(k)
FDA Class 2
·Ophthalmic
Baby Tischler Biopsy Punch Blue Titanium
FDA UDI
MEDGYN PRODUCTS, INC.·M803030179·Baby Tischler Biopsy Punch Blue Titanium 10" (2...
NUZONE NITRILE SURGICAL GLOVES POWDER FREE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
PARIETEX
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION SAS·Product code FTL·December 11, 2024
PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·August 30, 2019
DRIVE MEDICAL
FDA Adverse Event
Injury
·WUXI KANGQIANG INDUSTRIAL EQUIPMENT CO. LTD.·Product code ITJ·March 28, 2013
POWERED WHEELCHAIR
FDA Adverse Event
Other
·INVACARE·Product code ITI·March 15, 2011
DXTEND STAND PE CUP D38 +6MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWS·April 16, 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
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. 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