12 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MULTIPLE PRIVATE LABELS, NITRILE EXAM GLOVES, POWDER-FREE (WHITE)
FDA 510(k)
FDA Class 1
·General Hospital
OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
SAGITTAL SAW ATTACHMENT
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·November 20, 2013
DURATA STS OPTIM PASSIVE FIXATION LEAD, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CRMD·Product code NVY·January 13, 2014
PASSPORT 2 MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code DSI·April 30, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·May 17, 2011
BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·November 6, 2022
3.5MM TI CANCELLOUS POLYAXIAL SCREW 22MM
FDA Adverse Event
Injury
·SYNTHES PRODUKTIONS GMBH·Product code NKG·February 8, 2018
LOCKSCR SYNAPSE TAN
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKG·February 15, 2018
LOCKSCR SYNAPSE TAN
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKG·February 15, 2018
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