113 results · 27ms · Sources: EU EUDAMED, US FDA

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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