2,237 results · 15ms · Sources: EU EUDAMED, US FDA

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Wright EVOLVE TRIAD Plate Cutter, REF 49510120

FDA Recall
Open, Classified ·Wright Medical Technology, Inc.·Product code QLR·June 14, 2022

Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices

FDA classification
FDA Class 2 ·Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices

QUR Medical

Manufacturer
🇩🇰 Denmark·2 Basic UDI-DIs·2 Devices

DLR Medikal

Manufacturer
🇹🇷 Türkiye

QFR Solutions bv

Manufacturer
🇳🇱 Netherlands

GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

TS Crown Component 4UR (5/pk), TS Crown Component 5UR (5/pk), TS Crown Component 6UR (5/pk), TS Crown Component 4LR (5/pk), TS Crown Component 5LR (5/pk), TS Crown Component 6LR (5/pk), TS Crown Component 4UL (5/pk), TS Crown Component 5UL (5/pk), TS Crown Component 4LL (5/pk), TS Crown Component 5LL (5/pk), and TS Crown Component 6LL (5/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance

FDA Enforcement
Class II ·Terminated·Specialty Appliance Works, Inc.·April 29, 2015

TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC Crown Component 6UR (5/pk), TS ROC Crown Component 7UR (5/pk), TS ROC Crown Component 8UR (5/pk), TS ROC Crown Component 4LR (5/pk), TS ROC Crown Component 5LR (5/pk), TS ROC Crown Component 6LR (5/pk), TS ROC Crown Component 7LR (5/pk), TS ROC Crown Component 8LR (5/pk), TS ROC Crown Component 4UL (5/pk), TS ROC Crown Component 5UL (5/pk), TS ROC Crown Component 6UL (5/pk), TS ROC Crown Component 7UL (5/pk), TS ROC Crown Component 8UL (5/pk), TS ROC Crown Component 4LL (5/pk), TS ROC Crown Component 5LL (5/pk), TS ROC Crown Component 6LL (5/pk), TS ROC Crown Component 7LL (5/pk), TS ROC Crown Component 8LL (5/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.

FDA Enforcement
Class II ·Terminated·Specialty Appliance Works, Inc.·April 29, 2015

QFR SOLUTIONS BV

FDA registration
QFR SOLUTIONS BV·2 products·🇳🇱 Netherlands

CLR MEDICAL, INC.

FDA registration
CLR MEDICAL, INC.·2 products·🇺🇸 United States

SENSATION CATHETER

FDA Adverse Event
Injury ·GETINGE·Product code DSP·May 7, 2024

QUR sugetabletter

Device
EU MDR · Eu Md Class 1 ·QUR Medical·On the market·1 country

QUR Herpes Gel

Device
EU MDR · Eu Md Class 1 ·QUR Medical·On the market·1 country

TS Crown Component 4UR (5/pk), TS Crown Component 5UR (5/pk), TS Crown Component 6UR (5/pk), TS Crown Component 4LR (5/pk), TS Crown Component 5LR (5/pk), TS Crown Component 6LR (5/pk), TS Crown Component 4UL (5/pk), TS Crown Component 5UL (5/pk), TS Crown Component 4LL (5/pk), TS Crown Component 5LL (5/pk), and TS Crown Component 6LL (5/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance

FDA Recall
Terminated ·Specialty Appliance Works, Inc.·Product code ECN·March 9, 2015

TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC Crown Component 6UR (5/pk), TS ROC Crown Component 7UR (5/pk), TS ROC Crown Component 8UR (5/pk), TS ROC Crown Component 4LR (5/pk), TS ROC Crown Component 5LR (5/pk), TS ROC Crown Component 6LR (5/pk), TS ROC Crown Component 7LR (5/pk), TS ROC Crown Component 8LR (5/pk), TS ROC Crown Component 4UL (5/pk), TS ROC Crown Component 5UL (5/pk), TS ROC Crown Component 6UL (5/pk), TS ROC Crown Component 7UL (5/pk), TS ROC Crown Component 8UL (5/pk), TS ROC Crown Component 4LL (5/pk), TS ROC Crown Component 5LL (5/pk), TS ROC Crown Component 6LL (5/pk), TS ROC Crown Component 7LL (5/pk), TS ROC Crown Component 8LL (5/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.

FDA Recall
Terminated ·Specialty Appliance Works, Inc.·Product code ECN·March 9, 2015

POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

I-Series Washers

FDA UDI
SKYTRON LLC·10841736100360·I5 Universal two level processing rack, with 1 ...

I-Series Washers

FDA UDI
SKYTRON LLC·10841736100377·I5 Three level processing rack, with 2 rotating...

ROC Crown 3LR

FDA UDI
SPECIALTY APPLIANCES, LLC·D8199001470·

SS Crown 2LR

FDA UDI
SPECIALTY APPLIANCES, LLC·D8199001070·