10 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033778·Baltic Denture System BDLoad BDLoad Mm7 PLSEbi...
PEACE OF MIND HOME DRUG TEST
FDA 510(k)
FDA Unclassified
·Unknown
BREAST-BOARD (MULTIPLE)
FDA 510(k)
FDA Class 2
·Radiology
SPECTRANETICS QUICK-CROSS SUPPORT CATHETER
FDA Adverse Event
Injury
·THE SPECTRANETICS CORPORATION·Product code DQY·March 6, 2019
SECURE 3 MED/SURG BEDOBS 01/13
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 3, 2013
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 17, 2011
MYNX VASCULAR CLOSURE DEVICE
FDA Adverse Event
Injury
·ACCESSCLOSURE, INC.·Product code MGB·April 25, 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
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