7 results
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14ms
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Sources: EU EUDAMED, US FDA
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 Enforcement
Class II
·Terminated·Flower Orthopedics Corporation·October 20, 2021
ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic / spinal procedures.
FDA Enforcement
Class II
·Terminated·Zavation·June 9, 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 Enforcement
Class II
·Terminated·Flower Orthopedics Corporation·October 20, 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 Enforcement
Class II
·Terminated·Flower Orthopedics Corporation·October 20, 2021
NOMAD Pro2 Packaged X-Ray System, Part Number 08500021; NOMAD Pro2 Packaged X-Ray System Black, Part Number 08500022; NOMAD Pro2 Vet Packaged X-Ray System, Part Number 08500023; NOMAD Pro2 Vet Packaged X-Ray System Black, Part Number 08500024; NOMAD Pro2 Packaged X-Ray System, GBL, Part Number 08500025 and Part Number 08500026; NOMAD Pro2 Packaged X-Ray System, GLB, Vet, Part Number 08500027 and Part Number 08500028; NOMAD Pro2 Package X-Ray System, GLB, Black, Part Number 08500029
FDA Enforcement
Class II
·Terminated·Aribex Inc·September 14, 2016
Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including the current version, 2.1.4.
FDA Enforcement
Class II
·Terminated·Phadia Ab·April 11, 2018
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 Enforcement
Class II
·Terminated·B-K Medical A/S·August 10, 2016