11 results · 21ms · Sources: EU EUDAMED, 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