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

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BRACHYTHERAPY STRAND DEVICE

FDA 510(k)
FDA Class 2 ·Radiology

Leksell Stereotactic System

FDA UDI
Elekta Solutions AB·07340201502679·FIXATION SCREW 35 MM, TITANIUM

Myo/Wire II

FDA UDI
A & E MEDICAL CORPORATION·10841291101475·SS Suture, 6 per sleeve

ENDOCARE PERCUTANEOUS ACCESS SET

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

DORNIER DIODE LASER FAMILY MEDILAS D, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEM

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

81 CM (32") APPX 5.1 ML, 20 DROP BLOOD SET W/200 MICRON FILTER, ROTATING LUER, B

FDA Adverse Event
Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FJK·September 23, 2019

COMPLETE

FDA Adverse Event
Injury ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code LPN·April 17, 2020

GRANUFLO

FDA Adverse Event
Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 15, 2014

STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·February 15, 2011

PELVICOL ACELLULAR COLLAGEN MATRIX

FDA Adverse Event
Injury ·TISSUE SCIENCE LABORATORIES·Product code FTL·September 6, 2012

6.5MM TI RECON SCREW WITH T25 STARDRIVE 95MM

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 23, 2018

6.5MM TI RECON SCREW WITH T25 STARDRIVE 105MM

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 23, 2018

The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018