14 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PreXion3D Explorer
FDA 510(k)
FDA Class 2
·Radiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517578112·CoRoent Ant TLIF PEEK, 9x10x32mm 0°
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306822445·Hartman Ear Forceps, Alligator-style, 14cm
SILVERGLIDE
FDA UDI
STRYKER CORPORATION·04546540696182·ProSeries Non-Stick Bipolar Electrosurgical For...
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·October 4, 2021
CONQUEST SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SLENDERTONE SYSTEM ULTRA MODEL E70/X70
FDA 510(k)
FDA Class 2
·Physical Medicine
ARCOS CON SZ B STD 60MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·February 16, 2018
ACT ARTIC E1 HIP BRG 28X38MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·February 16, 2018
INTERSTIM
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·October 6, 2008
GYNECARE PROLIFT +M ANTERIOR PELVIC FLOOR REPAIR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·June 26, 2013
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·July 21, 2011
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EGS·April 10, 2019
BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020