15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12
FDA 510(k)
FDA Class 2
·Clinical Chemistry
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809872682·FOR MEN 15-20 MM HG THIGH MICRO DOT BAND CLOSED...
MODIFICATION TO VASCULAR CLOSURE DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS)
FDA 510(k)
FDA Class 2
·Orthopedic
CD HORIZON LEGACY MINI SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS, INC.·Product code MNI·February 3, 2012
MATRIXNEURO STERILE KIT STD 4
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code JEY·December 19, 2013
TI MATRIXNEURO BURR HOLE COVER24MM
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code JEY·October 28, 2015
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·April 3, 2013
ENDOTAK ENDURANCE RX
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 6, 2011
MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 1U I/C
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·June 23, 2013
MATNEU SCR Ø1.5 SELF-DRILL L4 TAN 4U I/C
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code JEY·August 28, 2015
ETEST DAPTOMYCIN DPC 256 WW S30
FDA Adverse Event
Malfunction
·BIOMÉRIEUX SA·Product code JWY·October 30, 2020
ETEST DAPTOMYCIN DPC 256 WW S30
FDA Adverse Event
Malfunction
·BIOMÉRIEUX SA·Product code JWY·October 30, 2020
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025