11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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WILSON-COOK TRI-TOME SELECT PLUS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257024423·OMOMED SHOULDER SUP SILVER R SIZE III
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033203·Baltic Denture System BDLoad BDLoad ↓ Sw7 PLSEu...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319700235·Comedone extract, 4" D/E FLAT
OSSTAPLE
FDA 510(k)
FDA Class 2
·Orthopedic
BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code PAH·April 3, 2013
LD304 MATERNITY BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code HDD·February 28, 2011
ABS2000
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·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