11 results · 40ms · Sources: EU EUDAMED, US FDA

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ALTA(R) PFX IM ROD

FDA 510(k)
FDA Class 2 ·Orthopedic

Brigade

FDA UDI
Nuvasive, Inc.·00887517963376·Brigade Lateral Trial, 6x38x28mm 20°

ReLine

FDA UDI
Nuvasive, Inc.·00195377068590·RELINE C Screw, 3.5x26mm MA

Solstice Occipito-Cervico-Thoracic System

FDA UDI
Life Spine, Inc.·00190837014506·

V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

SPECIALTY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY 55 UV MULTIFOCAL (METHAFILCON)

FDA 510(k)
FDA Class 2 ·Ophthalmic

PULSE GEN MODEL UNK

FDA Adverse Event
Injury ·CYBERONICS·Product code LYJ·January 9, 2013

TRIDENT 10 X 3 INSERT 36MM ID

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS CORK·Product code LPH·November 16, 2010

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·June 30, 2014

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