11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UNNA-SLEEVE(TM)
FDA 510(k)
FDA Class 2
·General Hospital
ReLine
FDA UDI
Nuvasive, Inc.·00195377068620·RELINE C Screw, 3.5x32mm MA
Brigade
FDA UDI
Nuvasive, Inc.·00887517963437·Brigade Lateral Trial, 12x38x28mm 20°
Solstice Occipito-Cervico-Thoracic System
FDA UDI
Life Spine, Inc.·00190837040703·3.5mm x 32mm SOLSTICE® Poly Screw Assm
AUTOREADER 2
FDA 510(k)
FDA Class 2
·Microbiology
HARDY DISK, CEFPODOXINE, 10MCG
FDA 510(k)
FDA Class 2
·Microbiology
530G INSULIN PUMP
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 30, 2014
MAXILL-DISTRACTOR MAIN BODY MONOAX DISTR
FDA Adverse Event
Malfunction
·SYNTHES·Product code JEY·January 9, 2013
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·November 19, 2010
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
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024