40 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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JO H2O Flavored Personal Lubricants
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BALANCE MICROPLASTY HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304455429·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694053259·Profile Zero, 25mm Gap Plate, Preformed
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197080330·CASTROVIEJO Micro Needle Holder
180mm,...
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
MODIFICATION TO:NESS L300
FDA 510(k)
FDA Class 2
·Neurology
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·December 4, 2019
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 30, 2022
PHILIPS SONICARE
FDA Adverse Event
Injury
·PHILIPS ORAL HEALTHCARE·Product code EFS·October 25, 2018
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2019
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·May 30, 2023
S-ICD SYSTEM
FDA Adverse Event
Injury
·CAMERON HEALTH INC.·Product code NVY·October 15, 2014
INSTINCT JAVA BLOCKER
FDA Adverse Event
Malfunction
·ZIMMER SPINE·Product code NKB·June 13, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 27, 2011
TRUEMETRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·October 20, 2017
COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LKF·April 20, 2021
COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LKF·April 30, 2021
COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LKF·April 20, 2021
COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LKF·April 20, 2021
COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LKF·April 22, 2021