43 results · 15ms · Sources: EU EUDAMED, US FDA

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2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

FDA Enforcement
Class II ·Terminated·Synthes (USA) Products LLC·March 14, 2018

Facial Tray, Kit number PSS1558(A convenience custom kits used for general surgery in hospital operating room

FDA Enforcement
Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous Probe REF 8065750821; Accurus 25+ 2500 CPM Standalone Vitreous Probe REF 8065751122; Anterior Accurus Probe with Infusion Needle REF 8065803650; Single Use Sterile Probes Rx only. Intended to provide the surgeon with a single-use probe for performing vitrectomy surgical procedures while using the Alcon Accurus vitrectomy console.

FDA Enforcement
Class II ·Terminated·Alcon Research, Ltd.·July 8, 2015

Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638, AMS3711, AMS4212, PSS1852(A, convenience custom kits used for general surgery in hospital operating room

FDA Enforcement
Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

Minor Pack AMS1374(A, CMP1560, PSS3517, PSS3517(A, PSS3518, PSS3518(A, PSS3541, and PSS3541(A. convenience custom kits used for general surgery in hospital operating room

FDA Enforcement
Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

FDA Enforcement
Class II ·Terminated·Synthes (USA) Products LLC·March 14, 2018

Lap Pack, part number AMS4801

FDA Enforcement
Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments and accessories intended for use during a surgical procedure.

FDA Enforcement
Class II ·Terminated·Resource Optimization & Innovation Llc·November 11, 2015

Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain

FDA Enforcement
Class II ·Terminated·Ivoclar Vivadent, Inc.·October 12, 2016

Peri GYN, part number PSS2193(A

FDA Enforcement
Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

Breast Augmentation Pack, part number AMS1786(A Breast Augmentation Pack, part number AMS2790(A Breast Augmentation Pack, part number AMS3324(B Breast Augmentation Pack, part number AMS4382 Breast Augmentation Pack, part number AMS4382(A Breast Augmentation Pack, part number AMS4382(B Breast Augmentation Pack, part number AMS4392 Breast Augmentation Pack, part number PSS3430

FDA Enforcement
Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring dental porcelain

FDA Enforcement
Class II ·Terminated·Ivoclar Vivadent, Inc.·October 12, 2016

Abdominoplasty Pack, Part numbers AMS3326(B, AMS4381, and AMS4381(B.

FDA Enforcement
Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For coloring dental porcelain

FDA Enforcement
Class II ·Terminated·Ivoclar Vivadent, Inc.·October 12, 2016

Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain

FDA Enforcement
Class II ·Terminated·Ivoclar Vivadent, Inc.·October 12, 2016

Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain

FDA Enforcement
Class II ·Terminated·Ivoclar Vivadent, Inc.·October 12, 2016

Total Hip Pack, Kit number PSS2956 convenience custom kits used for general surgery in hospital operating room

FDA Enforcement
Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain

FDA Enforcement
Class II ·Terminated·Ivoclar Vivadent, Inc.·October 12, 2016

Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring dental porcelain

FDA Enforcement
Class II ·Terminated·Ivoclar Vivadent, Inc.·October 12, 2016

MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

FDA Enforcement
Class II ·Terminated·Oscor, Inc.·December 28, 2016