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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