36 results · 22ms · Sources: EU EUDAMED, US FDA

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ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

MAYO SCISSORS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896099586·MAYO SCISSORS CURVED BEVELED BLADES POWER CUT GOLD

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112496·BARRON VACUUM TREPHINE 7.5MM

OsteoMed

FDA UDI
OSTEOMED LLC·00845694016971·MFx™ 2.0mm Rainbow Pilot Drill, Blunt Cannula, ...

TISSUE FORCEPS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896060678·TISSUE FORCEPS MICROSCOPIC CURVED TUNGSTEN CARB...

UNICEM

FDA 510(k)
FDA Class 2 ·Dental

CAP PORP, CAP TORP

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

EDWARDS ESHEATH+ INTRODUCER SET

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code DYB·April 28, 2022

UNKNOWN EDWARDS TRANSFEMORAL SHEATH

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code DYB·March 12, 2026

TF SHEATH UNKNOWN

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code DYB·July 18, 2023

UNKNOWN EDWARDS LIFESCIENCES SHEATH

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code DYB·May 12, 2025

EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES LLC·Product code NPT·December 5, 2024

OPHTHALMIC FEMTOSECOND LASER

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·February 9, 2021

TANDEM T:SLIM DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·October 22, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

ASR ACETABULAR CUPS 60

FDA Adverse Event
Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·July 1, 2013

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·January 11, 2021

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·January 11, 2021

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·March 5, 2021

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·AMO MANUFACTURING USA, LLC·Product code OOE·March 5, 2021