15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems
FDA 510(k)
FDA Class 2
·General Hospital
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756003735·Knee Immobilizer
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756962636·KNEE IMMOBILIZER
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756735216·KNEE IMMOBILIZER
FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 21, 2025
ACTIVE CRANIAL REFERENCE FRAME
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·October 23, 2024
1190917 19" CANVAS TRI-PANEL KNEE UNIV
FDA Adverse Event
Other
·DEROYAL INDUSTRIES, INC.·Product code ITQ·March 30, 2000
1190917 19" CANVAS TRI-PANEL KNEE UNIV
FDA Adverse Event
Other
·DEROYAL INDUSTRIES, INC.·Product code ITQ·February 25, 2000
1190917 19" CANVAS TRI-PANEL KNEE UNIV
FDA Adverse Event
Injury
·DEROYAL INDUSTRIES, INC.·Product code ITQ·February 25, 2000
6000CMS
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·June 14, 2013
EON MINI 16-CHANNEL RECHARGEABLE IPG
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 19, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 21, 2014
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 46, REF 106-22-46; d. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 48, REF 106-22-48; e. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 50, REF 106-22-50; f. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 52, REF 106-22-52; g. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 54, REF 106-22-54; h. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 48, REF 106-28-48; i. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 50, REF 106-28-50; j. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 52, REF 106-28-52; k. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 54, REF 106-28-54; l. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 56, REF 106-28-56; m. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 58, REF 106-28-58; n. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 60, REF 106-28-60; o. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 52, REF 106-32-52; p. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 54, REF 106-32-54; q. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 56, REF 106-32-56; r. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 58, REF 106-32-58; s. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 60, REF 106-32-60
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022