709 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CERCLAGE WIRES
FDA Adverse Event
Injury
·UNK·Product code JDQ·March 13, 2002
CABLE CRIMPER
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HXS·April 23, 2010
ADAPT Ø2.8 F/LCP PAED-HIP PL3.5/5.0
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXS·April 25, 2022
WIRE
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HXS·February 24, 2012
ADAPT Ø2.8 F/LCP PAED-HIP PL3.5/5.0
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXS·February 22, 2013
INTEGRA® JARIT®
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES PRODUCTION CORPORATION·Product code HXS·December 8, 2025
*
FDA Adverse Event
Malfunction
·SYNTHES·Product code HXS·July 3, 1997
BAUMGARTEN WIRE TWISTER
FDA Adverse Event
Malfunction
·PILLING SURGICAL·Product code HXS·October 21, 2005
INTEGRA JARIT
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES PRODUCTION CORPORATION·Product code HXS·September 8, 2021
MICROAIRE K-WIRE
FDA Adverse Event
Injury
·MICROAIRE SURGICAL INSTRUMENTS, LLC·Product code HXS·September 24, 2022
WIRE TWSITER
FDA Adverse Event
Malfunction
·ALTO DEVELOPMENT CORP.·Product code HXS·November 15, 2016
COMPR WIRE 1.6 L150/25
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HXS·August 28, 2012
CRIMPER F/TRANSV-ONNECTORS
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HXS·August 15, 2012
BAUMGARTEN WIRE TWISTER
FDA Adverse Event
Malfunction
·PILLING SURGICAL·Product code HXS·September 9, 2005
MICROAIRE K-WIRE
FDA Adverse Event
Injury
·MICROAIRE SURGICAL INSTRUMENTS, LLC·Product code HXS·September 24, 2022
TORQ Sternal Closure Device, SINGLE-USE Intended use: The device is a sterile, single-use only surgical instrument used to tension and twist USP size 5, 6, and 7 (metric size 7.0, 8.0, and 9.0) stainless steel surgical sutures for sternal closure. The device should not be used on patients with poor sternal bone quality.
FDA Recall
Terminated
·KARDIUM INC. 100·Product code HXS·March 31, 2010
TORQ Sternal Closure Device. The common name is TWISTER, WIRE. The model number is TQ01A. The Catalog numbers are: 17-00001: TORQ Sternal Closure Device Shipping Carton (6-10 packs), Sterile and, 15-00001 (or 17-00002): TORQ Sternal Closure Device 10-pack - Sterile. The device is supplied double-pouched, inside a shelf box containing 10 devices each. Shelf boxes are shipped to customers in either a small shipping carton containing one (1) shelf box (for a total of 10 devices), or large shipping carton containing six (6) shelf boxes (for a total of 6 x 10 = 60 devices). This product is used to close the sternal wires during cardiac surgery, and it is not an implantable device. The TORQ Sternal Closure device is used during sternal closure to tension and twist standard stainless steel surgical sutures of USP size 6 or 7 (metric size 8.0 or 9.0). The TORQ device is designed for use as a standard surgical suture wire twister for sternal closure. (Surgical sutures are not provided with the device.) The TORQ device is disposable, single-use, non-implantable and supplied sterile.
FDA Recall
Terminated
·Kardium 12851 Rowan Pl Richmond Canada British Columbia·Product code HXS·August 28, 2012
Twister, Wire
FDA classification
FDA Class 1
·Twister, Wire
MENS-O-MATIC 1XS AND MENS-O-MATIC 2XS
FDA 510(k)
FDA Class 2
·Neurology
HMS-VILGO
FDA registration
HMS-VILGO·3 products·🇫🇷 France