14 results
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27ms
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Sources: EU EUDAMED, US FDA
ORTHO CHLAMYDIA ANTIGEN ELISA/ELISA CULT EXTRA BUF
FDA 510(k)
FDA Class 1
·Microbiology
VuePoint
FDA UDI
Nuvasive, Inc.·00887517177070·VuePoint Cross Conn, 3.5x32mm Fixed Rod
FRESHKONALLURING EYES, FRESHKON COLORS FUSION, FRESHKONCOLORS FUSION SPARKLERS, FRESHKON MOSAIC, FRESHKON GLITZI
FDA 510(k)
FDA Class 2
·Ophthalmic
DERMAGRIP POWDER FREE BLUE POLYMER COATED LATEX EXAMINATION GLOVE, NON-STERILE CONTAINS 50 MICROGRAM OR LESS OF TOTAL WA
FDA 510(k)
FDA Class 1
·General Hospital
ADULT BREATHING CIRCUIT DUAL HEATED
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·June 15, 2007
AXIOS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 2, 2024
VANGUARD SSK 360 R FEMORAL 70MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·June 30, 2014
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 17, 2010
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·January 2, 2013
AXIOS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 26, 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
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024