36 results · 23ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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