11 results
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40ms
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Sources: EU EUDAMED, US FDA
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