14 results
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15ms
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Sources: EU EUDAMED, US FDA
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