13 results · 19ms · Sources: EU EUDAMED, US FDA

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3MP Color LCD Monitor (CL-S301)

FDA 510(k)
FDA Class 2 ·Radiology

SpheRx

FDA UDI
Nuvasive, Inc.·00887517442789·SpheRx® II Hook, 8mm Lamina Narrow

PULSE OXIMETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

MACROPORE HYDROSORB SPINE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

STAXX XD

FDA Adverse Event
Injury ·SPINE WAVE, INC.·Product code MQP·November 21, 2008

ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC IRELAND·Product code NIQ·August 16, 2011

AIR DERMATOME HANDPIECE

FDA Adverse Event
Malfunction ·ZIMMER SURGICAL·Product code GFD·July 18, 2013

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020