108 results
·
22ms
·
Sources: EU EUDAMED, US FDA
LOCK DISTAL FIBULA PLT,SS LFT,4H
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HRS·January 27, 2020
INTERNALBRACE LIGAMENT
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code MAI·January 27, 2020
LO-PRO LOCK SCRW,SS 2.7X 12MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·January 27, 2020
LOCKING LATERAL HOOK PLATE, 5 HOLE, SS
FDA Adverse Event
Injury
·ARTHREX INC.·Product code HWC·February 21, 2018
LOCKING LATERAL HOOK PLATE, 5 HOLE, SS
FDA Adverse Event
Injury
·ARTHREX INC.·Product code HWC·February 21, 2018
KNOTLESS TIGHT-ROPE SYN-DESMOSIS REPR KIT,SS
FDA Adverse Event
Injury
·ARTHREX INC.·Product code HTN·February 21, 2018
LOCKING LATERAL HOOK PLATE, 5 HOLE, SS
FDA Adverse Event
Injury
·ARTHREX INC.·Product code HWC·February 21, 2018
LOCKING LATERAL HOOK PLATE, 5 HOLE, SS
FDA Adverse Event
Injury
·ARTHREX INC.·Product code HWC·February 21, 2018
LOCKING LATERAL HOOK PLATE, 5 HOLE, SS
FDA Adverse Event
Injury
·ARTHREX INC.·Product code HRS·February 21, 2018
LOCKING THIRD TUBULAR PLATE, SS, 8H
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HRS·February 6, 2025
LO-PRO SCRW TM,SS 3.5X 16MMCORT
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·February 6, 2025
LO-PRO SCRW TM,SS 3.5X 14MMCORT
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·February 6, 2025
KREULOCK COMPRESSION SCREW, SS, 3.5X16MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HRS·February 6, 2025
LOW PROF SCRW,SS 4.0X 45MMCANN,SHT THD
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·February 6, 2025
LO-PRO SCRW TM,SS 3.5X 14MMCORT
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·February 6, 2025
LOW PROF SCRW,SS 4.0X 45MMCANN,SHT THD
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·February 6, 2025
KREULOCK COMPRESSION SCREW, SS, 3.5X10MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HRS·February 6, 2025
LO-PRO SCRW TM,SS 3.5X 12MMCORT
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HWC·February 6, 2025
CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code HRS·December 26, 2019
Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following product numbers: (1) REF 1882916, RAD 60 Sinus Blade, 11 cm x 2.9 mm; (2) REF 1883514, RAD 12 Curved Sinus Blade, 11 cm x 3.5 mm; (3) REF 1884013, Powered Tonsillectomy Blade, 11 cm x 4 mm; (4) REF 1884020, Tricut Laryngeal Blade, 22.5 cm x 4 mm; (5) REF 1884032, Tracheal Blade, 37 cm x 4 mm; (6) REF 1884033, Tracheal Blade, Angle Tip; (7) REF 1882902HRE, Serrated Blade, 11 cm X 2.9 mm, Rotatable; (8) REF 1882905HRE, Silver Bullet Blade, 11 cm x 2.9 mm, Rotatable; (9) REF 1882924HRE, Skimmer Blade, 27 cm x 2.9 mm, Rotatable; (10) REF 1882936E, Angle-Tip Serrated Blade, 18 cm x 2.9 mm; (11) REF 1882937E, Angle-Tip Serrated Blade, 22 cm x 2.9 mm; (12) REF 1882979HRE, Skimmer Blade, 13 cm x 2.9 mm, Rotatable; (13) REF 1883080HRE, Quadcut Blade, 3.0 mm, Rotatable; (14) REF 1883480HRE, Quadcut Blade, 3.4 mm, Rotatable; (15) REF 1883502HRE, Serrated Blade, 11 cm x 3.5 mm, Rotatable; (16) REF 1883506HRE, RAD 40 Blades, 11 cm x 3.5 mm, Rotatable; (17) REF 1883512HRE, RAD 12 Blade, 11 cm x 3.5 mm, Rotatable; (18) REF 1883516HRE, RAD 60 Blade, 11 cm x 3.5 mm, Rotatable; (19) REF 1884005HRE, Silver Bullet Blade, 11 cm x 4 mm, Rotatable; (20) REF 1884030HRE, Tricut Airway Blade, Angled Tip, 22 cm x 4 mm, Rotatable; (21) REF 1884031HRE, Tricut Airway Blade, Angled Tip, 27 cm x 4 mm, Rotatable; (22) REF 1884033HRE, Tricut Airway Blade, Angled Tip, 37 cm x 4 mm, Rotatable; (23) REF 1884380HR, Quadcut Blade, 4.3 mm, Rotatable; (24) REF 1884380HRE, Quadcut Blade, 4.3 mm, Rotatable.
FDA Enforcement
Class II
·Ongoing·Medtronic Xomed, Inc.·October 27, 2021