259 results · 16ms · Sources: EU EUDAMED, US FDA

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InterV, 10G Kyphoplasty Kits, REF numbers: a) INTVM-10-DSK b) INTVM-10-SBK c) INTVM-15-DSK d) INTVM-15-DSKC e) INTVM-15-SBK f) INTVM-15-SIKBC g) INTVM-20-DSK h) INTVM-20-SBK. For use in Orthopedic / spinal procedures.

FDA Recall
Terminated ·Zavation·Product code NDN·March 25, 2021

ZVplasty 10G, 15mm Single Balloon Kit, REF VCF-SBK. For use in Orthopedic / spinal procedures.

FDA Recall
Terminated ·Zavation·Product code NDN·March 25, 2021

VERTEBREX SINGLE BALLOON KIT, REF VBRX-20-SBK-10. For use in Orthopedic / spinal procedures.

FDA Recall
Terminated ·Zavation·Product code NDN·March 25, 2021

VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10. For use in Orthopedic / spinal procedures.

FDA Recall
Terminated ·Zavation·Product code NDN·March 25, 2021

Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws and can be used with any the Flower Small and Medium Implant Set Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set or Flower Upper Extremity Plating Set and uses the medium locking mechanism. Catalog Number: DBK 027

FDA Recall
Terminated ·Flower Orthopedics Corporation·Product code HTW·September 1, 2021

Flower Drill Bit Kit 2.4 mm-intended to be used with solid 2.4mm screws and can be used with any plate as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. Catalog Number: DBK 024

FDA Recall
Terminated ·Flower Orthopedics Corporation·Product code HTW·September 1, 2021

Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. mechanism. Catalog Number: DBK 020 2013002721

FDA Recall
Terminated ·Flower Orthopedics Corporation·Product code HTW·September 1, 2021

Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate that as part of the Flower Small and Medium Implant Set, Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set , or Flower Upper Extremity Plating Set and uses the medium locking mechanism. Catalog Number: LSK 027

FDA Recall
Terminated ·Flower Orthopedics Corporation·Product code HTW·September 1, 2021

ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic / spinal procedures.

FDA Recall
Terminated ·Zavation·Product code NDN·March 25, 2021

Syneture Sofsilk 3/0 BK 12X18" PRE-CUT WAX-RACE non-absorbable braided nylon sutures S194 Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery

FDA Recall
Terminated ·Product code GAP·June 3, 2011

Single-use sterile puncture attachment UA1256-U used with the BK Medical Ultrasounds: Diagnostic Ultrasound scanner Pro Focus 2202 and Diagnostic Ultrasound Transducer 8667 Diagnostic Ultrasound scanner 2102 and Diagnostic Ultrasound Transducer 8667 Diagnostic Ultrasound scanner 2101 and Diagnostic Ultrasound Transducer 8667 Performing ultrasound guided biopsies of the prostate.

FDA Recall
Terminated ·Bk Medical Mileparken 34 Iierlev Denmark·September 8, 2008

BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN

FDA Recall
Terminated ·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·June 28, 2016

VIASYS VELA Ventilator, Catalog Number-16186; Viasys Respiratory Care, Inc.

FDA Recall
Terminated ·Viasys Respiratory Care, Inc.dba Bird Products·Product code CBK·January 31, 2007

Maquet Servo Ventilator SV900C/D/E (SV900) Siemens-Elema AB, Solna, Sweden

FDA Recall
Terminated ·MAQUET Inc.·Product code CBK·November 17, 2009

Ventilator System SERVO-i V3.1 PC1777 Maquet Critical Care

FDA Recall
Terminated ·MAQUET Inc.·Product code CBK·May 23, 2006

Ventilator System Servo-i V3.1 Maquet Critical Care PC1771

FDA Recall
Terminated ·MAQUET Inc.·Product code CBK·May 23, 2006

RP Diaphragm Exhalation model number FC06372. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

FDA Recall
Terminated ·Respironics, Inc.·Product code CBK·October 15, 2007

Rotating Connector Packaged model number 302209. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

FDA Recall
Terminated ·Respironics, Inc.·Product code CBK·October 15, 2007

Newport e360 Ventilator, Rx only. The e360 Ventilator System is intended to provide continuous (endotracheal or tracheostomy [ET] tube) or non-continuous (mask) ventilatory support and monitoring for infant, pediatric, and adult patients requiring tidal volumes equal to or greater than 20 milliliters (mL).

FDA Recall
Terminated ·Newport Medical Instruments Inc·Product code CBK·December 15, 2008

Hamilton brand RAPHAEL Silver Ventilator (Software Version 2.2xS) Product is distributed by Hamilton Medical, Inc., 4990 Energy Way, Reno, NV 89502

FDA Recall
Terminated ·Hamilton Medical Inc·Product code CBK·May 24, 2006