26 results · 24ms · Sources: EU EUDAMED, US FDA

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EARPROBE

FDA 510(k)
FDA Class 2 ·Neurology

SEILER COLPOSCOPE, MODELS 935, 955 AND 985

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·August 19, 2022

SURESTEP

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CGA·January 29, 1999

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 14, 2023

ONE TOUCH ULTRA

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·May 17, 2004

COBAS INTEGRA 400+

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JGS·August 15, 2007

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 28, 2025

ALINITY C PROCESSING MODULE

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code JJE·February 16, 2024

RSP SHOULDER

FDA Adverse Event
Other ·ENCORE MEDICAL, L.P.·Product code KWS·May 23, 2013

ATTAIN STARFIX

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

OT PING ENHANCED METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 1, 2014

COBAS 6000 C501MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·November 6, 2008

TRUE METRIX

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·May 9, 2022

MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAN·March 7, 2024

PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAW·March 7, 2024

COBAS 6000 C501 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JGS·February 18, 2014

ARCHITECT C8000

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code JJE·September 20, 2021

COBAS 6000 C501 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JGS·October 5, 2012