10,000 results
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71ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BISQUE ZIRCONIA BLANKS, TYPE BYZ
FDA 510(k)
FDA Class 2
·Dental
WAVELIGHT FS200 FEMTOSECOND LASER
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code GEX·May 25, 2017
WAVELIGHT FS200 FEMTOSECOND LASER
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code GEX·May 1, 2017
HEARTSTART FR2+
FDA Adverse Event
Other
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 8, 2010
GORE® CARDIOFORM SEPTAL OCCLUDER
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MLV·December 12, 2019
R SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·December 6, 2024
GORE® CARDIOFORM SEPTAL OCCLUDER
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MLV·December 12, 2019
TRULIGN TORIC POSTERIOR CHAMBER IOL
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code MJP·March 23, 2023
UNKNOWN PYRAMESH
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code EZX·December 5, 2014
QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA For use as a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries
FDA Enforcement
Class II
·Terminated·Z-Medica, LLC·June 28, 2017
INTRALASE FS2
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HNO·January 25, 2016
QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA For use as a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries
FDA Recall
Terminated
·Z-Medica, LLC·Product code FRO·May 17, 2017
UNKNOWN KYPHOPLASTY
FDA Adverse Event
Injury
·MDT KYPHON SUNNYVALE MFG·Product code HRX·April 23, 2012
UNKNOWN KYPHOPLASTY
FDA Adverse Event
Injury
·MDT KYPHON SUNNYVALE MFG·Product code HRX·April 23, 2012
UNKNOWN KYPHOPLASTY
FDA Adverse Event
Injury
·MDT KYPHON SUNNYVALE MFG·Product code HRX·April 23, 2012
UNKNOWN KYPHOPLASTY
FDA Adverse Event
Injury
·MDT KYPHON SUNNYVALE MFG·Product code HRX·April 23, 2012
UNKNOWN KYPHOPLASTY
FDA Adverse Event
Injury
·MDT KYPHON SUNNYVALE MFG·Product code HRX·April 23, 2012
UNKNOWN KYPHOPLASTY
FDA Adverse Event
Injury
·MDT KYPHON SUNNYVALE MFG·Product code HRX·April 23, 2012
UNKNOWN KYPHOPLASTY
FDA Adverse Event
Injury
·MDT KYPHON SUNNYVALE MFG·Product code HRX·April 23, 2012
UNKNOWN KYPHOPLASTY
FDA Adverse Event
Injury
·MDT KYPHON SUNNYVALE MFG·Product code HRX·April 23, 2012