12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
UNKNOWN PATHINDER NXT OR INSTINCT JAVA IMPLANT
FDA Adverse Event
Malfunction
·ZIMMER BIOMET SPINE INC.·Product code NKB·September 24, 2022
ROD, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019
PEDICLE SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019
PEDICLE SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019
STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR
FDA 510(k)
FDA Class 2
·General Hospital
FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH
FDA 510(k)
FDA Class 2
·Cardiovascular
TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC
FDA Adverse Event
Injury
·COOK INC·Product code LJS·December 3, 2015
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·May 29, 2013
RECAP FEM HD COCR CEMENTED DIA48MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·October 1, 2014
KYPHOPLASTY
FDA Adverse Event
Injury
·MEDTRONIC SPINE LLC.·Product code HRX·June 17, 2011
Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is an accessory used with the CUSA Excel+ System ultrasonic surgical instrument. The torque wrench is used to properly secure the CUSA tip to the CUSA handpiece in the sterile field.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·May 7, 2014