20 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Cardiovascular
VERTE-STACK ANATOMIC PEEK STRUT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MQP·May 5, 2020
OCULAR SCIENCES, INC. BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS
FDA 510(k)
FDA Class 2
·Hematology
INTERLAKE CONTINENTAL WATER SYSTEMS
FDA Adverse Event
Death
·INTERLAKE CONTINENTAL WATER SYSTEMS·Product code FIP·December 14, 1993
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 23, 2026
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·September 12, 2019
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 22, 2013
ARTICUL/EZE BALL 28 +8.5 BL
FDA Adverse Event
Injury
·JOHNSON AND JOHNSON MEDICAL (DEPUY - SUZHOU) LTD.·Product code JDI·April 25, 2011
KINETRA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·July 3, 2008
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·January 2, 2019
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·February 12, 2019
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·March 8, 2019
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·February 18, 2019
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·January 3, 2020
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·January 2, 2020
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·July 26, 2019
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·November 20, 2019
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·November 8, 2019
ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LIT·July 12, 2024