17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Delta Multihole TT Pro Acetabular System
FDA 510(k)
FDA Class 2
·Orthopedic
ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAILS
FDA 510(k)
FDA Class 2
·Orthopedic
UNIMAX ANTI-FOG SOLUTION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FEMORAL POSTERIOR AUGMENT CEMENTED
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·June 2, 2022
STEM EXTENSION STRAIGHT SPLINED UNCEMENTED
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·June 2, 2022
FEMORAL DISTAL AUGMENT CEMENTED
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·June 2, 2022
TIBIAL AUGMENT CEMENTED HALF BLOCK
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·June 2, 2022
FEMORAL DISTAL AUGMENT CEMENTED
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·August 17, 2022
TIBIAL AUGMENT CEMENTED HALF BLOCK
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·August 17, 2022
SEE H10 NARRATIVE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·May 16, 2023
SEE H10 NARRATIVE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·May 16, 2023
TIBIA FIXED CEMENTED LEFT SIZE D STEM EXTENSION
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·May 16, 2023
TIBIAL AUGMENT CEMENTED HALF BLOCK
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBH·August 17, 2022
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 22, 2014
FREESTYLE PRECISION H
FDA Adverse Event
Injury
·Product code NBW·June 26, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 20, 2011
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