10 results
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27ms
·
Sources: EU EUDAMED, US FDA
P-S SURGICAL DRAIN
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
16PW - Washington Gas - Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588014425·16PW - Washington Gas - Poly White
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209128877·
ESU HANDSWITCHING PENCIL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HEART SYNC PEDIATRIC, MODEL PED-100
FDA 510(k)
FDA Class 2
·Cardiovascular
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 8, 2014
UNKNOWN RIGHT HIP
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·October 17, 2012
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·August 16, 2010
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
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