19 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Implantcast ic-Bipolar Head System
FDA 510(k)
FDA Class 2
·Orthopedic
V-TRUST MODEL TD-2202 PORTABLE ECG RECORDER
FDA 510(k)
FDA Class 2
·Cardiovascular
PLATEAU SPACER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BD MGIT 960 PZA
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code MJA·February 2, 2024
BD MGIT 960 PZA
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO.·Product code MJA·January 30, 2024
BD MGIT 960 PZA
FDA Adverse Event
Malfunction
·BECTON DICKINSO & CO.·Product code MJA·January 30, 2024
BD MGIT 960 PZA
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code MJA·February 2, 2024
BD MGIT 960 PZA
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code MJA·February 2, 2024
BD MGIT 960 PZA
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO.·Product code MJA·January 30, 2024
BD MGIT 960 PZA
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code MJA·February 2, 2024
BD MGIT 960 PZA
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code MJA·February 2, 2024
BD MGIT 960 PZA
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code MJA·February 2, 2024
BD MGIT 960 PZA
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO.·Product code MJA·January 30, 2024
BD MGIT 960 PZA
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO.·Product code MJA·February 2, 2024
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
MEDEL S.P.A.·Product code BTI·June 26, 2013
3002 SECURE II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·July 1, 2011
BLADE EXTENDER FOR ADULT LARYNGOSCOPE, 6/PKG
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC. - NORWALK·Product code CCW·July 23, 2008
BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA) Catalog Number: 245128
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·August 28, 2024
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 1 CUPS, REF 130-28-51 b. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 2 CUPS, REF 130-32-52 c. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 3 CUPS, REF 130-36-53 d. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 4 CUPS, REF 130-36-54 e. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 5 CUPS, REF 130-36-55 f. NOVATION GXL LINER, +5 LAT 32MM ID, GROUP 3 CUPS, REF 136-32-53 g. NOVATION GXL LINER, +5 LAT 32MM ID, GROUP 4 CUPS, REF 136-32-54 h. NOVATION GXL LINER, +5 LAT 32MM ID, GROUP 5 CUPS, REF 136-32-55 i. NOVATION GXL LINER, +5LAT, 28MM G1-48/50MM CUPS, REF 136-28-51 j. NOVATION GXL LINER, +5LAT, 32MM G1-48/50MM CUPS, REF 136-32-51 k. NOVATION GXL LINER, +5LAT, 32MM G2-52/54MM CUPS, REF 136-32-52 l. NOVATION GXL LINER, +5LAT, 36MM G2-52/54MM CUPS, REF 136-36-52 m. NOVATION GXL LINER, +5LAT, 36MM G3-56/58MM CUPS, REF 136-36-53 n. NOVATION GXL LINER, +5LAT, 36MM G4-60/62MM CUPS, REF 136-36-54 o. NOVATION GXL LINER, +5LAT, 36MM G5-64/66/68MM CUPS, REF 136-36-55 p. NOVATION GXL LINER, 10 DEG FACE, 32MM ID, GRP 1 CUP, REF 138-32-51 q. NOVATION GXL LINER, 10 DEG FACE, 32MM ID, GRP 3 CUP, REF 138-32-53 r. NOVATION GXL LINER, 10 DEG FACE, 36MM ID, GRP 2 CUP, REF 138-36-52 s. NOVATION GXL LINER, 10 DEG FACE, 36MM ID, GRP 3 CUP, REF 138-36-53 t. NOVATION GXL LINER, 10 DEG FACE, 36MM ID, GRP 4 CUP, REF 138-36-54 u. NOVATION GXL LINER, 10 DEG FACE, 36MM ID, GRP 5 CUP, REF 138-36-55 v. NOVATION GXL LINER, 10 DEG FACE, REPLACED BY 138-36-52, REF 138-32-52 w. NOVATION GXL LINER, LIPPED 32MM ID GROUP 2 CUPS, REF 132-32-52 x. NOVATION GXL LINER, LIPPED ANT, 32MM ID, GROUP 1 CUPS, REF 132-32-61 y. NOVATION GXL LINER, LIPPED ANT, 36MM ID, GROUP 2 CUPS, REF 132-36-62 z. NOVATION GXL LINER, LIPPED ANT, 36MM ID, GROUP 3 CUPS, REF 132-36-63 aa. NOVATION GXL LINER, LIPPED ANT, 36MM ID, GROUP 4 CUPS, REF 132-36-64 bb. NOVATION GXL LINER, LIPPED, 36MM ID, GROUP 3 CUPS, REF 132-36-53 cc. NOVATION GXL LINER, LIPPED, 28MM ID, GROUP 1 CUPS, REF 132-28-51 dd. NOVATION GXL LINER, LIPPED, 28MM ID, GROUP 2 CUPS, REF 132-28-52 ee. NOVATION GXL LINER, LIPPED, 32MM ID GROUP 4 CUPS, REF 132-32-54 ff. NOVATION GXL LINER, LIPPED, 32MM ID, GROUP 3 CUPS, REF 132-32-53 gg. NOVATION GXL LINER, LIPPED, 32MM ID, GROUP 5 CUPS, REF 132-32-55 hh. NOVATION GXL LINER, LIPPED, 36MM ID GROUP 4 CUPS, REF 132-36-54 ii. NOVATION GXL LINER, LIPPED, 36MM ID, GROUP 5 CUPS, REF 132-36-55 jj. NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 2 CUPS, REF 130-28-52 kk. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 3 CUPS, REF 130-32-53 ll. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 4 CUPS, REF 130-32-54 mm. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 5 CUPS, REF 130-32-55
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022