11 results
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19ms
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Sources: EU EUDAMED, US FDA
CORNING 184 BLOOD GAS TONOMETER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Symmetry MICROCARE®
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482031261·Microcare Case Flex, Large, Length 21 Inches
ACUMED
FDA UDI
Acumed LLC·10806378050213·Browne-type Retractor, Carbon Fiber
LONG NAIL KIT R2.0, TI, LEFT GAMMA3 11X400MM X 12
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 1, 2012
ACTI-FLEX IV ADMINISTRATION SET
FDA 510(k)
FDA Class 2
·General Hospital
RVT CTO DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
GORE® EXCLUDER® AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·May 9, 2014
HEARTSTART FRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 18, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 25, 2007
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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