15 results · 22ms · Sources: EU EUDAMED, 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