42 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SYNCHRON SYSTEMS AMPHETAMINE REAGENT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PowerPICC
FDA UDI
Bard Access Systems, Inc.·00801741121203·Catheter Placement Kit
N/A
FDA UDI
Ortho Development Corporation·00822409090372·Alpine Reamer 19-20
PROLITE
FDA UDI
Atrium Medical Corporation·00650862300079·ProLite Mesh, 6" x 6" (15cm x 15cm)
AMSafe® EXTENSION SET
FDA UDI
AMSINO INTERNATIONAL, INC.·10704411002703·AMSafe® EXTENSION SET
10.5" (26.8 cm) Long, Non...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450155646·
4WEB Medical
FDA UDI
4web Medical·00812998043408·
LIFENET Connect
FDA UDI
PHYSIO-CONTROL, INC.·00883873952863·LIFENET Connect RELEASE 5.3.3
FlowLogic Assert
FDA UDI
SONENDO, INC.·00810209420604·FlowLogic Assert Shaping File 20/.04, 21mm
IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·September 2, 2024
Ambu
FDA UDI
SUNMED, LLC·10889483222201·Ambu Disposable Hyperinflation System, Hyperinf...
SOLACE Sacroiliac Fixation System
FDA UDI
XENIX MEDICAL LLC·00818345029316·10.5mm Implant Guide to Pin Guide, 22mm
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 12, 2013
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·February 2, 2011
MILLENNIUM MICROSURGICAL SYSTEM
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HNO·February 15, 2008
BD PLASTIPAK¿ STERILE PLASTIC SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMF·August 15, 2023
MESH PROLITE SHEETS
FDA Adverse Event
Malfunction
·ATRIUM MEDICAL CORPORATION·Product code FTL·September 6, 2022
Nichols Advantage Invasive Trophoblast Antigen (ITA)Assay Cartridges (Catalog #62-7052)
FDA Recall
Terminated
·Nichols Institute Diagnostics·Product code DHA·August 31, 2005