9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DISPOSABLE ISOLATION GOWN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PAQ.210X140X156.EDAN SE1201
FDA UDI
AB MEDICA GROUP, S.A.·08428763009955·
SYNTEX POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES WITH LOW PROTEIN CLAIM
FDA 510(k)
FDA Class 1
·General Hospital
LungTrainer (MD2 & MD3)
FDA 510(k)
FDA Class 2
·Anesthesiology
14MM/130 DEG TI CANN TFNA 380MM/LEFT-STERILE
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·August 15, 2018
RESTORE SENSOR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 17, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 9, 2010
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2014
RT-5100 Refractor, a component of the Epic-5100 System.
FDA Enforcement
Class III
·Terminated·Nidek Inc.·December 26, 2018