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M.K. WITH 03ML FLUSH DEVICE FOR DRISCOLL FOUNDATION CHILDRENS HOSP., Item No. 46068-02 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

FDA Enforcement
Class II ·Terminated·ICU Medical, Inc.·November 23, 2016

Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·November 15, 2017

HipLOC Hip Fracture Fixation System-Hiploc System 140¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-140-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures

FDA Enforcement
Class II ·Terminated·Biomet UK Ltd.·October 3, 2018

HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-135-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures

FDA Enforcement
Class II ·Terminated·Biomet UK Ltd.·October 3, 2018

HipLOC Hip Fracture Fixation System- Hiploc System 130¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-130-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures

FDA Enforcement
Class II ·Terminated·Biomet UK Ltd.·October 3, 2018

HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 3 Hole Plate Item Number: 2110-135-003 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures

FDA Enforcement
Class II ·Terminated·Biomet UK Ltd.·October 3, 2018

Medicina Oral Tip Syringe 2.5ml Code: OT25

FDA Enforcement
Class II ·Ongoing·Medicina Uk Ltd·October 26, 2022

Medicina Oral Tip Syringe 1ml Code: OT01

FDA Enforcement
Class II ·Ongoing·Medicina Uk Ltd·October 26, 2022

Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD

FDA Enforcement
Class II ·Ongoing·Medicina Uk Ltd·October 26, 2022

Medicina Oral Tip Syringe 0.5ml Code: OT005

FDA Enforcement
Class II ·Ongoing·Medicina Uk Ltd·October 26, 2022

Medicina Reusable Oral syringe 5ml Code: OTH05

FDA Enforcement
Class II ·Ongoing·Medicina Uk Ltd·October 26, 2022

Medicina Reusable Oral syringe 2.5ml Code: OTH25

FDA Enforcement
Class II ·Ongoing·Medicina Uk Ltd·October 26, 2022

Medicina Reusable Oral syringe 1ml Code: OTH01

FDA Enforcement
Class II ·Ongoing·Medicina Uk Ltd·October 26, 2022

Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05

FDA Enforcement
Class II ·Ongoing·Medicina Uk Ltd·October 26, 2022