19 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ONTEX AND OTHER PROPRIETARY NAMES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
EMT - Siemens Trauma - Red Bag
FDA UDI
Certified Safety Manufacturing, Inc.·00766588226033·EMT - Siemens Trauma - Red Bag
ELMED
FDA UDI
ELMED INCORPORATED·00842180164178·Lahey Hemostatic Forcep, Curved OL 140mm(5 1/2")
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523166879·Initia Acetabular Standard Liner, E-CIMA 22-60/...
SA FLOWABLE ADHESIVE
FDA 510(k)
FDA Class 2
·Dental
IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD INTIMA IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code FOZ·May 16, 2007
LIFEPAK(R) 1000 DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·July 10, 2015
IMMULITE 2000
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CFP·January 23, 2012
IMMULITE 2000
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CFP·February 2, 2012
LIFEPAK® 1000 DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·April 24, 2019
VECTORVISION FLUORO 3D
FDA Adverse Event
Other
·BRAINLAB AG·Product code HAW·May 15, 2013
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·June 14, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 20, 2008
IMMULITE 2000 INSULIN
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code CFP·January 27, 2012
IMMULITE 2000 INSULIN
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code CFP·February 1, 2012
Model M4735A HeartStart XL Defibrillator//Monitor
FDA Recall
Terminated
·Philips Medical Systems·Product code MKJ·September 2, 2003
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024