13 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES
FDA 510(k)
FDA Class 2
·Neurology
Deploy™ Expandable Interbody System
FDA UDI
Southern Spine LLC·00815351022522·Lumbar Expandable Cage, 8 Degree, 32mm Length, ...
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526780804·LEVAMED ACTIVE ANKLE SUP SLVR R II
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587T0812320·8mm TLIF Implant 12mm Wide 32mm Length
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587T08123270·8mm TLIF Implant 12mm Wide 32mm Length 7 Degrees
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0112320·Tap, 4.75mm, Fixed Sleeve
CONSTELLATION CATHETERS, MODEL 8031M
FDA 510(k)
FDA Class 2
·Cardiovascular
NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM 50 MICROGRAMS OR LESS
FDA 510(k)
FDA Class 1
·General Hospital
UNKNOWN
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·January 2, 2025
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC·Product code OTP·April 26, 2013
FUSION NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 21, 2011
ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP
FDA Adverse Event
Injury
·NORTH HAVEN - USS·Product code GDO·July 23, 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