23 results · 30ms · Sources: EU EUDAMED, US FDA

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CYNOSURE APOGEE-TKS II DERMATOLOGICAL LASER

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Generic Buccal Tubes

FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746153822·DB TUBE INCONEL UR 2ND MOL 022 T-10 R6D 4.5MM

NARKOMED MRI , NM-MRI

FDA 510(k)
FDA Class 2 ·Anesthesiology

SPIRABRUSH CX BIOPSY INSTRUMENT

FDA 510(k)
FDA Class 1 ·Obstetrics/Gynecology

ACTIVA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·August 26, 2013

SOLETRA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·April 19, 2012

CD HORIZON® SPINAL SYSTEM

FDA Adverse Event
Malfunction ·Product code KWP·November 2, 2021

CD HORIZON® SPINAL SYSTEM

FDA Adverse Event
Malfunction ·Product code KWP·November 2, 2021

CD HORIZON® SPINAL SYSTEM

FDA Adverse Event
Malfunction ·Product code KWP·November 2, 2021

ACTIVA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·March 1, 2013

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 2, 2013

SYNCHROMED II

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·March 25, 2011

"REDY"

FDA Adverse Event
Death ·Product code FKT·April 17, 2008

LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

SOLETRA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·November 13, 2013

ACTIVA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·November 13, 2013

LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL

FDA Adverse Event
Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·February 13, 2018

LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

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

The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016