10 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SURGICAL DRAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PAQ.210X300X200/QT-80HS/KENZ 1211
FDA UDI
AB MEDICA GROUP, S.A.·08428763009863·
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123069·K-WIRE - DOUBLE TROCAR 1.0mm DIA x 100mm
OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ISIS SUBGLOTTIC ET TUBE 7.5MM
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTR·November 11, 2010
UNKNOWN DEPUY PINNACLE METAL LINER
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·January 17, 2013
OT VERIO IQ 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
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025