25 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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THERMODILUTION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
JOBST Bella Strong
FDA UDI
BSN MEDICAL, INC.·00035664012250·BELLA STRONG 20-30 MM HG GAUNTLET SIZE 1 BLACK ...
Oticon
FDA UDI
Oticon A/S·05707131158352·VGPC, BTE 13 P TC VIGO PRO CONNECT
BD LUER-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·November 14, 2024
BW ACUPUNCTURE NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
HANGER CRANIAL BAND
FDA 510(k)
FDA Class 2
·Neurology
BD ULTRA-FINE¿ NANO¿ PEN NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·April 5, 2019
TAMPAX RADIANT TAMPON UNSCENTED, ABSORBENCY UNKNOWN
FDA Adverse Event
Malfunction
·TAMBRANDS MANUFACTURING, INC·Product code HEB·March 10, 2021
TAMPAX RADIANT TAMPON UNSCENTED, ABSORBENCY UNKNOWN
FDA Adverse Event
Malfunction
·TAMBRANDS MANUFACTURING, INC·Product code HEB·March 3, 2021
BD ULTRA FINE¿ INSULIN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·December 21, 2017
TOTAL CARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·April 30, 2013
PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 56MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·September 19, 2014
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·May 11, 2011
BD ULTRA FINE¿ PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·April 12, 2019
BD ULTRA FINE¿ PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·April 11, 2019
BD ULTRA-FINE¿ MINI PEN NEEDLES 5MM (3/16¿) 31G
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·April 10, 2019
BD ULTRA FINE¿ PEN NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·May 28, 2019
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 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
VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021