891 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EPICARE YAG
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SORBAFIX
FDA UDI
Davol Inc.·00801741016691·SorbaFix Absorbable Fixation System, 36 cm leng...
JOBST forMen Casual
FDA UDI
BSN MEDICAL, INC.·00035664131159·FOR MEN CASUAL 15-20 MM HG KNEE HIGH CLOSED TOE...
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0131150·Rocker, Hinged Locking
SIros-X
FDA UDI
Genesys Orthopedics Systems LLC·M719GSIX1131150·SIros-X Awl Tipped Taps, 11.5mm
PRODIGY DIABETES MANAGEMENT SOFTWARE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
2027971-2025-113115
FDA Adverse Event
Injury
·NOBEL BIOCARE USA, LLC·Product code DZE·August 9, 2025
PLUMSET CLAVE PORT CLAVE SITE 103IN NDHP
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 9, 2013
VICRYL POLYGLACTIN 910 SUTURE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·September 24, 2014
TOTAL HIP BALL 28MM +3
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·May 20, 2011
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·January 29, 2021
QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·August 9, 2023
PARIETEX
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION SAS·Product code FTL·January 6, 2021
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·August 21, 2023
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·April 27, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 23, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·January 17, 2023
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·November 10, 2023
T:SLIM G5 SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OYC·August 24, 2021