43 results
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25ms
·
Sources: EU EUDAMED, US FDA
ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
SleepWeaver Elan - Mask & Headgear - Small - Blue
FDA UDI
CIRCADIANCE, LLC·B036100728·SleepWeaver Elan Cloth Nasal PAP Mask & Headgea...
DEBAKEY TANGENTIAL OCCLUSION CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896003187·DEBAKEY TANGENTIAL OCCLUSION CLAMP DOUBLE ANGLE...
DEBAKEY TANGENTIAL OCCLUSION CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921007280·DEBAKEY TANGENTIAL OCCLUSION CLAMP DOUBLE ANGLE...
Orthoquest
FDA UDI
Young Innovations, Inc.·00843471155950·T Nat D 021X025 Lo
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450188019·
HARMONE-SCHWARZER EEG SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEOPUFF INFANT RESUSCITATOR
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTL·November 4, 2010
OXYGENATOR, CARDIOPULMONARY BYPASS
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTZ·July 15, 2015
ARSTASIS ACCESS SYSTEM
FDA Adverse Event
Other
·ARSTASIS INC.·Product code DYB·November 15, 2010
ARSTASIS ACCESS SYSTEM
FDA Adverse Event
Malfunction
·ARSTASIS, INC.·Product code DYB·November 19, 2010
ARSTASIS ACCESS SYSTEM
FDA Adverse Event
Other
·ARSTASIS, INC.·Product code DYB·November 22, 2010
ARSTASIS ACCESS SYSTEM
FDA Adverse Event
Injury
·ARSTASIS, INC.·Product code DYB·November 1, 2010
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 8, 2013
S4S/SUR-FIT NATURA 2PC - 2PC DURAHESIVE (DH) MOLDABLE WAFER
FDA Adverse Event
Injury
·CONVATEC, INC.·Product code EXE·September 12, 2014
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 12, 2011
MEDTRONIC TRANSCATHETER VALVE
FDA Adverse Event
Injury
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·December 2, 2025
Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac surgery in combination with a heart lung machine to oxygenate blood, remove carbon dioxide and adjust blood temperature.
FDA Enforcement
Class II
·Terminated·Maquet Cardiovascular Us Sales, Llc·December 31, 2014
Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-001U Product Usage: The Navigation System II-Cart is intended to be used as a platform for computer assisted surgery as part of the Stryker Navigation System. The intended use of the complete Stryker Navigation System is defined by the Stryker application modules.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·June 24, 2015