12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Patient Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
CORRIDOR LIGHT,LED,2 GANG,UNIVERSAL
FDA UDI
Crest Healthcare Supply·B48411525520·CORRIDOR LIGHT,LED,2 GANG,UNIVERSAL
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690124443·Modular Offset Stem 15mm x 150mm x 2mm
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106341·STERN-CASTROVIEJO FORCEPS W/ LOCK 0.5MM
HYBRID ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HEMOSIL LA POSITIVE CONTROL
FDA 510(k)
FDA Class 2
·Hematology
PLUM A+3 W/MEDNET NE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·October 6, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 7, 2013
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 27, 2011
TR BAND
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DXC·May 26, 2023
TR BAND
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DXC·May 26, 2023
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023