9 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIGITAL PULSE OXIMETER, MODEL 7500FO
FDA 510(k)
FDA Class 2
·Cardiovascular
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489125556·PowerChem Neoprene Exam Gloves, Extra Large
Epimed
FDA UDI
EPIMED INTERNATIONAL, INC·00818788020345·RX-2™ Coudé® Epidural Needle 15g RW x 3.5"
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 469
FDA 510(k)
FDA Class 1
·Clinical Toxicology
ALPCO MILENIA ANTI-TG EIA
FDA 510(k)
FDA Class 2
·Immunology
ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code KNT·April 22, 2013
POLARIS URETERAL STENT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code FAD·April 15, 2011
ACCU-CHEK ULTRAFLEX INFUSION SET
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS·Product code FPA·July 7, 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