113 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·EXCIMED(TM) UV200LA LASER SYSTEM
Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·SVS APEX PLUS EXCIMER LASER WORKSTATION
Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·SVS APEX PLUS EXCIMER LASER WORKSTATION
Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·SVS APEX PLUS EXCIMER LASER WORKSTATION
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756994897·VASCULAR PACK
Equator Attachment Cap Strong Violet
FDA UDI
NOGA MEDICAL PRODUCTS LTD·07290118143499·Equator Attachment Cap Strong Violet
25° Angulated Abutment H2mm Ti Wide
FDA UDI
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION·10810190011284·
25° Angulated Abutment H2mm Ti Wide
FDA UDI
NOGA MEDICAL PRODUCTS LTD·07290118141761·25° Angulated Abutment H2mm Ti Wide
PTI STERNAL CLOSURE WIRE SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·AXSYM TOTAL PSA & ARCHITECT TOTAL PSA
Gases Used Within Eye To Place Pressure On Detached Retina
FDA Pre-Market Approval
FDA Class 3
·SULFUR HEXAFLUORIDE
ALINITY I TOTAL PSA REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MTF·November 17, 2025
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES·Product code LZG·February 25, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 10, 2010
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·December 19, 2012
ARCHITECT TOTAL PSA
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MTF·February 25, 2026
ALINITY I TOTAL PSA REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MTF·May 20, 2025
ALINITY I TOTAL PSA REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MTF·April 21, 2025
Gases Used Within Eye To Place Pressure On Detached Retina
FDA Pre-Market Approval
FDA Class 3
·SULFUR HEXAFLUORIDE FOR PNEUMATIC RETINOPEXY
FDA Pre-Market Approval
ARCHITECT Total PSA / Alinity i Total PSA