24 results
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8ms
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Sources: EU EUDAMED, US FDA
Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek Usa, Inc - Dallas Distribution·December 2, 2015
Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek Usa, Inc - Dallas Distribution·May 11, 2016
- Cannulated Drill Bit for Mini TightRope Ref. AR-8911DC Lot 122511 - Drill Bit, Straight Shank 2.7mm x 12.7cm Ref. 2318-027-00 Lot 122322 - Drill Bit, w/Depth Mark, Quick Coupling (Red) 2.0mm x 140mm Ref. 323.062 Lot 122347 - Fast Cutting Drill Bit 2.0mm Ref. FDB 2.0 Lot 122289, 122322 - Midas Rex Metal Cutting Drill Bit 3.0mm x 18.3mm Ref. MC30 Lot 122347 Orthopedic manual surgical instrument
FDA Enforcement
Class II
·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013
UltraStream Chronic Hemodialysis Catheter Standard Kit; Model Number 32101524 (24 cm), 32101528 (28cm), 32101532 (32 cm), and 32101536 (36 cm) and 32102540 (40 cm). The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressure.
FDA Enforcement
Class II
·Terminated·Argon Medical Devices, Inc·October 1, 2014
UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 32001532 (32 cm), and 32001536 (36 cm) and 32002540 (40 cm). The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressures.
FDA Enforcement
Class II
·Terminated·Argon Medical Devices, Inc·October 1, 2014
UltraStream Peel Away Kit; Model Numbers 32401524 (24 cm), 32401528 (28cm), 32401532 (32 cm), and 32401536 (36 cm) and 32402540 (40 cm) The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressure.
FDA Enforcement
Class II
·Terminated·Argon Medical Devices, Inc·October 1, 2014
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 Enforcement
Class II
·Terminated·Pro-Dex Inc·August 28, 2019
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 Enforcement
Class II
·Terminated·Pro-Dex Inc·March 23, 2016
Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
FDA Enforcement
Class II
·Terminated·Pro-Dex Inc·March 23, 2016
Thio Med w/o Ind, w/Dex (9ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
FDA Enforcement
Class II
·Terminated·Remel Inc·May 29, 2019
Thio Med w/Dex, Hem, Vit K (7ml) 20/PK Product Usage; Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
FDA Enforcement
Class II
·Terminated·Remel Inc·May 29, 2019
Thio Med w/Dex, Hem, Vit K (5ml) 100/PK Product Usage; Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
FDA Enforcement
Class II
·Terminated·Remel Inc·May 29, 2019
Thio Med w/o Ind, w/Dex (18ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
FDA Enforcement
Class II
·Terminated·Remel Inc·May 29, 2019
Thio Med w/Dex, Hem, Vit K (9ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
FDA Enforcement
Class II
·Terminated·Remel Inc·May 29, 2019
Thio Med w/o Ind, w/Dex (18ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
FDA Enforcement
Class II
·Terminated·Remel Inc·May 29, 2019
Thio Med w/Dex, Hemin, Vit K (5ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
FDA Enforcement
Class II
·Terminated·Remel Inc·May 29, 2019
Thio Med w/o Ind, w/Dex (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
FDA Enforcement
Class II
·Terminated·Remel Inc·May 29, 2019
Thio Med w/o Ind, w/Dex (10ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
FDA Enforcement
Class II
·Terminated·Remel Inc·May 29, 2019
Thio Med w/Dex, Hem, Vit K(10ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
FDA Enforcement
Class II
·Terminated·Remel Inc·May 29, 2019
Thio Med w/Dex, Hem, Vit K (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
FDA Enforcement
Class II
·Terminated·Remel Inc·May 29, 2019