11 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC
FDA 510(k)
FDA Class 2
·Cardiovascular
Oticon
FDA UDI
Oticon A/S·05707131283191·H11V2, MINIBTE 312 WL 85 TC
Elastic Separating Plier
FDA UDI
Ortho Organizers, Inc.·00190707102340·Elastic Separating Plier
Elastic Separating Plier
FDA UDI
Ortho Organizers, Inc.·00190707103217·Elastic Separating Plier
MICROLIFE NON-CONTACT INFRARED FOREHEAD THERMOMETER, MODEL FR1DZ1
FDA 510(k)
FDA Class 2
·General Hospital
AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE
FDA 510(k)
FDA Class 2
·Anesthesiology
CRIT-LINE BLOOD CHAMBER
FDA Adverse Event
Malfunction
·CONCORD MANUFACTURING·Product code KOC·July 21, 2018
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
HL CORP. (SHENZHEN)·Product code ITJ·June 6, 2013
STANDARD INSERT
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 29, 2011
ULTRACISION HARMONIC SCALPEL CURVED SHEARS, SCISSOR-GRIP HANDLE - 14 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GEI·August 28, 2008
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018