12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE
FDA 510(k)
FDA Class 2
·Cardiovascular
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033464·Baltic Denture System BDLoad BDLoad Mn7 PLSEbi...
GEM, MODEL 004110
FDA 510(k)
FDA Class 2
·Anesthesiology
VIRIDIS TWIN OPHTHALMIC PHOTOCOAGULATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INSERTER FOR TI ELASTIC NAILS
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code LXH·December 1, 2020
ABRAMS MULTIDENSITY POLYURETHAN FOAM WOUND DRESSING SYSTEM
FDA Adverse Event
Other
·DR LEN'S MEDICAL PRODUCTS·Product code FRO·October 11, 2005
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·April 3, 2013
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·March 23, 2011
PALIND 23/40 SLOT KIT W/VT
FDA Adverse Event
Malfunction
·TYCO HEALTHCARE/KENDALL·Product code MPB·April 23, 2008
UNKNOWN PFM-R DISTAL STEM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·March 13, 2018
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024