16 results · 17ms · Sources: EU EUDAMED, US FDA

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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