12 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
MARKERS
FDA Adverse Event
Malfunction
·PRAXIM·Product code HAW·January 3, 2007
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0311930·Probe, 1.75 inch, Egg, Steffee, Long, Curved
JEL BIOS 90 (CODE NAME RD-2401)
FDA 510(k)
FDA Class 2
·Dental
IQUANTIFY, VERSION 1.0
FDA 510(k)
FDA Class 2
·Radiology
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·April 2, 2013
CUSTOM VLIFT INSERTER
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code LXH·March 17, 2011
ENTERRA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LNQ·April 18, 2008
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code BWC·September 4, 2019
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
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016