16 results
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17ms
·
Sources: EU EUDAMED, US FDA
INTEC FULL FACE SHIELD
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GALAXY FIXATION GEMINI
FDA UDI
ORTHOFIX SRL·18053340348898·GALAXY FIXATION GEMINI STERILIZATION TRAY LAYER
The Orthodontic Store
FDA UDI
Young Innovations, Inc.·00840326406694·Pf Tray Md Upr #3
RADspeed Pro
FDA UDI
SHIMADZU CORPORATION·04540217052370·
NA
FDA UDI
Zimmer, Inc.·00889024104792·
NA
FDA UDI
Zimmer, Inc.·00889024079939·
NA
FDA UDI
Zimmer, Inc.·00889024104808·
AFFINITY CVR
FDA 510(k)
FDA Class 2
·Cardiovascular
SCHNEIDER SOFTIP SST ANGIOGRAPHIC (DIAG) CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
CONSERVE(R) TOTAL HEAD W/BFH
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KWA·February 6, 2013
UNO
FDA Adverse Event
Malfunction
·LIKO AB·Product code FSA·December 17, 2010
QUICKSET 1PC FLEX DRILL BIT 45
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC.·Product code LXH·July 21, 2014
D7120, BG-OX Cartridge, D7120 REF 946-003, and 946-001, cuvettes for the NPT7 series of blood gas analyzers.
FDA Recall
Terminated
·Radiometer America Inc·Product code CHL·January 12, 2005
Dri-Tek BG-OX Cartridge, Model #D7120, Cat. #946-003 Cartridges used in the NPT7 Analyzer, an in vitro diagnostic device.
FDA Recall
Terminated
·Radiometer America Inc·Product code CHL·May 1, 2006
PKG, 3MM PEEK MULTI-FUNCTION HANDLE, P/N 0250282046 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370
FDA Enforcement
Class II
·Ongoing·Osteomed, LLC·December 15, 2021