11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model
FDA 510(k)
FDA Class 2
·Cardiovascular
CoRoent
FDA UDI
Nuvasive, Inc.·00887517638489·CoRoent Ant TLIF PEEK, 16x12x32mm 12°
Sonic
FDA UDI
Sonic Innovations, Inc.·05711583027173·CL80 P, VC PS GR CELEBRATE 80
HARTMANN-HALLE NASAL SPECULUM
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896018358·HARTMANN-HALLE NASAL SPECULUM MEDIUM BLADES
Endoscopic injection needle
FDA UDI
ENDO-THERAPEUTICS, INC.·00816207020945·Endoscopic injection needle
STINGRAY CERVICAL CAGE; SHARK IMPLANT (PLIF); BULL SHARK IMPLANT(PLIF); TIGER IMPLANT (TLIF); GREAT WHITE IMPLANTS(ALIF)
FDA 510(k)
FDA Class 2
·Orthopedic
RESTORELLE POLYPROPYLENE Y MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DUR MAR +4 NEUT LNR 36X54
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·July 7, 2011
CAREASSIST BED
FDA Adverse Event
Malfunction
·HILLROM DE MEXICO S DE RL DE CV·Product code FNL·May 31, 2013
MTOME ST HOLSTER/CABLES
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code KNW·September 8, 2008
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