36 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GLASIONOMER FX-II
FDA 510(k)
FDA Class 2
·Dental
Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·October 22, 2014
Generic Buccal Tubes
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746153600·WELD TUBE INCONEL LR MOL SGL 018 T-25 R6D 2MM N...
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·October 25, 2017
ROSS EMBRACE PUMP SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DA VINCHI EMG/EP ISA1004EP
FDA 510(k)
FDA Class 2
·Neurology
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·August 3, 2020
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·May 11, 2020
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code NKB·February 3, 2010
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code NKB·February 3, 2010
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NKB·December 22, 2017
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·February 26, 2019
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·September 26, 2018
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·August 2, 2019
ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·April 2, 2013
POSEY SITTER SELECT
FDA Adverse Event
Malfunction
·J. T. POSEY COMPANY·Product code KMI·March 18, 2011
IAB: 7.5 FR - 40 CC
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·April 18, 2008
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·May 12, 2017
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·May 12, 2017
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 2, 2018