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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EP-WORKMATE SYSTEM, VERSION 4.2
FDA 510(k)
FDA Class 2
·Cardiovascular
OMEGA XP
FDA UDI
SPINAL ELEMENTS·00840916124618·OMEGA XP™ 9MM X 28MM X 10MM 0° LUMBAR EXPANDABL...
COBRASCAN CR-1 FILMLESS
FDA 510(k)
FDA Class 2
·Radiology
ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY
FDA 510(k)
FDA Class 2
·Dental
AVALUS AORTIC TISSUE VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·June 23, 2020
BD¿ ULTRA-FINE INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·January 11, 2019
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 3, 2013
RNGLC+ LTD HOLE FIN SHL SZ50
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·September 16, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 5, 2011
UNKNOWN ELASTOMERIC LFR
FDA Adverse Event
Malfunction
·AVANOS MEDICAL - IRVINE·Product code MEB·March 9, 2020
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