10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IDOC UPPER ARM ATTACHED BLOOD PRESSURE AND PULSE RATE MONITOR, MODEL ID-42A/ID-43A
FDA 510(k)
FDA Class 2
·Cardiovascular
RESORBABLE SCREW ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
R&D PROJECT DW271#11A
FDA 510(k)
FDA Class 2
·Dental
CELLEX PHOTOPHERESIS SYSTEM
FDA Adverse Event
Malfunction
·MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED·Product code LNR·May 2, 2024
BRONCHIAL THERMOPLASTY CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code OOY·April 11, 2013
RSVR MMT-326A 10PK PRDGM 1.8ML 13L
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code FMF·May 27, 2008
ARTICUL/EZE BALL 32 +9 BL
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code JDI·April 7, 2011
BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·January 2, 2020
FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/410851; BACT/ALERT FN Plus/410852; BACT/ALERT PF Plus/410853
FDA Enforcement
Class II
·Terminated·BioFire Diagnostics, LLC·April 24, 2019
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