22 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Batrik In-Brush Twisted Wire Brushes
FDA UDI
Batrik Medical Manufacturing Inc·00690521005587·Brush\6Fraizier\BD-2.00mm\BL-25.4mm\OL-250mm - ...
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100190·SNII Tap, 7.50mm
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K0100090·Tamp, Oblique Kicker
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100090·Dilator Sleeve, Screwdriver
ADVIA CENTAUR CP TROPONIN ULTRA (TNI ULTRA)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·February 6, 2014
NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO
FDA 510(k)
FDA Class 2
·Physical Medicine
ADVIA CENTAUR XP TROPONIN ULTRA ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·March 14, 2014
ADVIA CENTAUR XP TROPONIN ULTRA ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·February 27, 2014
ADVIA CENTAUR XP TROPONIN ULTRA ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·February 13, 2014
HEARTMATE 3 LVAS IMPLANT KIT
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·January 20, 2023
AXSYM DIGOXIN III
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code KXT·May 11, 2007
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 8, 2011
ADVIA CENTAUR TROPONIN ULTRA ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·January 21, 2014
ADVIA CENTAUR CP TROPONIN ULTRA ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·April 2, 2014
ADVIA CENTAUR CP TROPONIN ULTRA ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·April 15, 2014
ADVIA CENTAUR XP TROPONIN ULTRA ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·May 1, 2014
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012