11 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LUNGPOINT PROCEDURE PLANNING
FDA 510(k)
FDA Class 2
·Radiology
AMDS Hybrid Prosthesis ("AMDS")
FDA UDI
Artivion, Inc.·00877234001222·55mm – 40mm Tapered Stent (32mm collar)
ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS
FDA 510(k)
FDA Class 2
·Microbiology
X3 TRIATHLON CS INSERT #3 9MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·May 13, 2014
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 24, 2022
ROUND FILTER POLYPROVPYLENE
FDA Adverse Event
Malfunction
·SPS MEDICAL SUPPLY CORP·Product code FRG·June 25, 2013
ARTICUL/EZE BALL 28 +1.5 GR
FDA Adverse Event
Injury
·8010379 DEPUY INTL., LTD.·Product code JDI·May 6, 2013
SWARTZ BRAIDED TRANSSEPTAL INT., 8F, SL1
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, AF DIVISION·Product code DYB·April 12, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 5, 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