14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FORTIFY Corpectomy Spacers
FDA 510(k)
FDA Class 2
·Orthopedic
Sonic
FDA UDI
Sonic Innovations, Inc.·05711583027128·CL100 P, VC PS TP CELEBRATE 100
STAXX XDL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SUPERDIMENSION/BRONCHUS PREMIUM 2
FDA 510(k)
FDA Class 2
·Radiology
TITAN RES ECLD 125CC
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code FHW·December 21, 2018
M2A-T M/H RAD 2HL SHL 41/58MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·October 12, 2017
32MM M2A MOD HEAD +3MM NK
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWY·October 12, 2017
M2A-TAPER LINER SZ 41/32
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·October 12, 2017
INTERCHANGEABLE ULNAR ASSEMBLY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDC·October 22, 2019
STANDARD STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM DE MEXICO S DE RL DE CV·Product code FPO·May 23, 2013
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 14, 2011
LIGACLIP ENDSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CLI
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·September 8, 2008
INTERCHANGEABLE HUMERAL ASSEMBLY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDC·October 22, 2019
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