250 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Recall
×
SOZO Bilateral Arm L-Dex Software
FDA Recall
Open, Classified
·Product code OBH·August 17, 2023
KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter.
FDA Recall
Open, Classified
·Pro-Dex Inc·Product code GET·February 14, 2023
DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25
FDA Recall
Open, Classified
·Katalyst Surgical, LLC·Product code HNR·March 25, 2026
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27
FDA Recall
Open, Classified
·Katalyst Surgical, LLC·Product code HNR·March 25, 2026
DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23
FDA Recall
Open, Classified
·Katalyst Surgical, LLC·Product code HNR·March 25, 2026
DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25
FDA Recall
Open, Classified
·Katalyst Surgical, LLC·Product code HNR·March 25, 2026
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S
FDA Recall
Open, Classified
·Katalyst Surgical, LLC·Product code HNR·March 25, 2026
PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2 Product Usage: -The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the PDSD Surgical driver. There is only one PDSD Surgical driver currently being produced (PDSD-5000) and the battery only works to power this driver. -The PDSD Series surgical drivers are Pro-Dex Branded surgical fixation drivers meant to drive surgical screws into bone in the CMF region of the body. They are class I exempt (Product codes GEY/GXL) battery powered hand pieces with a fixed collet. The only accessory is the PDBP-001 battery.
FDA Recall
Terminated
·Pro-Dex Inc·Product code GEY·September 25, 2018
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S
FDA Recall
Open, Classified
·Katalyst Surgical, LLC·Product code HNR·March 25, 2026
DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25
FDA Recall
Open, Classified
·Katalyst Surgical, LLC·Product code HNR·March 25, 2026
DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23
FDA Recall
Open, Classified
·Katalyst Surgical, LLC·Product code HNR·March 25, 2026
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S
FDA Recall
Open, Classified
·Katalyst Surgical, LLC·Product code HNR·March 25, 2026
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S
FDA Recall
Open, Classified
·Katalyst Surgical, LLC·Product code HNR·March 25, 2026
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S
FDA Recall
Open, Classified
·Katalyst Surgical, LLC·Product code HNR·March 25, 2026
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27
FDA Recall
Open, Classified
·Katalyst Surgical, LLC·Product code HNR·March 25, 2026
Zimmer PTW4321 20 Ncm Dental Torque Wrench, QTY 1 Pro-Dex Inc, Irvine, CA 92614 The Dental Torque Wrench is used to fasten dental implant abutments during the placement of dental implants.
FDA Recall
Terminated
·Pro-Dex Inc dba Dyna-Dent·Product code DZE·January 19, 2009
Clinac High Energy Medical Linear Accelerator, Medical Charged-particle radiation therapy system; Model #s: 2100(C,C/D EX) and 2300 C, C/D EX)
FDA Recall
Terminated
·Varian Medical Systems Inc·Product code IYE·August 31, 2006
Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
FDA Recall
Terminated
·Pro-Dex Inc·Product code MOQ·December 23, 2015
Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
FDA Recall
Terminated
·Pro-Dex Inc·Product code MOQ·December 23, 2015
VIDAS DEX@, Dimer Exclusion II, REF 30455-01
FDA Recall
Open, Classified
·bioMerieux, Inc.·Product code DAP·September 22, 2021