10 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INION SPINAL GRAFT CONTAINMENT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Rongeur
FDA UDI
KATENA PRODUCTS, INC.·00841668108529·BEYER RONGEUR SINGLE ACTION
Acapella One
FDA UDI
Choice Spine, LP·00840996151436·ACAPELLA,TRIAL,CX,NS,14X18X10
URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING
FDA 510(k)
FDA Class 2
·Orthopedic
CONCERTO II CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·April 22, 2013
ACCU-CHEK SPIRIT
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·April 21, 2011
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 8, 2008
Philips Zenition 50, Model Number: 718096
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024
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