16 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CUFFINK
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526799417·MANUMED ACTIVE WRIST LEFT SAND L
28mm x 11mm x 14mm Oblique with Inserter
FDA UDI
XENCO MEDICAL LLC·B064XM01128141·28mm x 11mm x 14mm Oblique TLIF with Inserter
InFill Lordotic TLIF
FDA UDI
PINNACLE SPINE GROUP, LLC·00814729025189·
InFill Convex TLIF
FDA UDI
PINNACLE SPINE GROUP, LLC·00814729024915·
COLLAGEN NERVE CUFF
FDA 510(k)
FDA Class 2
·Neurology
ELECYSYS SHBG
FDA 510(k)
FDA Class 1
·Clinical Chemistry
POUNCE VENOUS THROMBECTOMY SYSTEM
FDA Adverse Event
Injury
·SURMODICS INC·Product code QEW·May 16, 2024
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 14, 2013
PINN CAN BONE SCREW 6.5MMX15MM
FDA Adverse Event
Injury
·JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043·Product code NDJ·September 24, 2014
ASR UNI FEMORAL IMPL SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 18, 2011
ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020
ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020
AMISTEM H HA COATED STD STEM SIZE 5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 8, 2021
Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;
FDA Enforcement
Class II
·Ongoing·Ventec Life Systems, Inc.·June 30, 2021
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021