24 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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OBIX PERINATAL DATA SYSTEM 7.0
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Accufuse Cervical System
FDA UDI
ABSOLUTE ADVANTAGE MEDICAL, LLC·00810016800675·Cervical Cage PEEK 12mmx12mmx8mm 7° lordosis
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756612487·Wrist Splint
DURAVENT
FDA UDI
Andreas Fahl Medizintechnik-Vertrieb GmbH·04051948007183·DURAVENT UNI XL 2 ICU, SIZE 8
IMMULITE 2000 MIXED ALLERGEN PANELS
FDA 510(k)
FDA Class 2
·Immunology
INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VACUTRON
FDA UDI
Allied Medical, LLC·00026072003923·MINI-VAC,SUR, CHEM X BARB
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·March 26, 2022
VACUTRON
FDA UDI
Allied Medical, LLC·00026072003947·MINI-VAC,SUR,CHEM X BARB
VACUTRON
FDA UDI
Allied Medical, LLC·00026072003978·MINI-VAC,SUR,CHEM X BARB
VACUTRON
FDA UDI
Allied Medical, LLC·00026072003961·MINI-VAC,SUR,CHEM X BARB
VACUTRON
FDA UDI
Allied Medical, LLC·00026072003954·MINI-VAC,SUR,CHEM X BARB
VACUTRON
FDA UDI
Allied Medical, LLC·00026072003985·MINI-VAC,SUR,CHEM X BARB
VACUTRON
FDA UDI
Allied Medical, LLC·00026072003930·MINI-VAC,SUR,CHEM X BARB
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 20, 2013
ASR ACETABULAR CUPS 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 1, 2011
2024601-2008-00006
FDA Adverse Event
Malfunction
·Product code LTI·January 3, 2008
VENTED AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·February 18, 2014
VENTED AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·February 18, 2014
ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee includes cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee can also support the acquisition of position triggered imaging for spatial data synthesis.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·November 21, 2018