58 results · 53ms · Sources: EU EUDAMED, US FDA

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WELLS BIO, INC.

Manufacturer
🇰🇷 South Korea

careGENE™ Viral/Pathogen HiFi Nucleic Acid Isolation kit

FDA UDI
WELLS BIO, INC.·08809446080841·

caerGENE™ Viral/Pathogen HiFi Nucleic Acid Isolation kit-N

FDA UDI
WELLS BIO, INC.·08809446082029·

UNICEL® DXC 800 SYNCHRON ® CHEMISTRY ANALYZER

FDA Adverse Event
BECKMAN COULTER INC.·Product code JJE·October 29, 2010

UNICEL® DXC 600I SYNCHRON ® CHEMISTRY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·December 23, 2010

DURA-GUARD

FDA Adverse Event
Injury ·BIO-VASCULAR, INC.·Product code GXQ·September 22, 1997

DURA-GUARD

FDA Adverse Event
Injury ·BIO-VASCULAR, INC.·Product code GXQ·September 22, 1997

ORTHO SAMPLE PROCESSOR

FDA Adverse Event
Malfunction ·HAMILTON BONADUZ AG·Product code JTC·March 11, 2010

DURA-GUARD

FDA Adverse Event
Injury ·BIO-VASCULAR, INC.·Product code GXQ·December 19, 1997

SKYTRON

FDA Adverse Event
MIZUHO·Product code GDC·March 14, 2012

UNK

FDA Adverse Event
Malfunction ·ARTHREX, INC.·Product code HWC·May 29, 2024

ENDOWRIST

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·September 20, 2023

O-ARM 1000 IMAGING SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·November 11, 2016

RHEUMATOID FACTOR REAGENT

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code DHR·November 4, 2011

ENDOWRIST

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·May 22, 2023

ENDOWRIST

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·May 26, 2026

Variant II Turbo Hemoglobin A1c Program, model number 270 2417, manufactured by Bio-Rad Laboratories, Inc, Hercules, CA. Intended Use: For the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC).

FDA Recall
Terminated ·Bio-Rad Laboratories Inc·Product code LCP·October 12, 2009

VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAM·May 26, 2022

ENDOWRIST;DAVINCI SI

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·May 31, 2018

BIOGRAFT

FDA Adverse Event
Injury ·BIO-VASCULAR, INC.·Product code LXA·March 11, 1998