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

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Tandem Mobi Insulin Pump with Interoperable Technology

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114179·KRATZ POLISHER 23GA SIDE (PK/10)

BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE

FDA 510(k)
FDA Class 2 ·General Hospital

RDH-2000

FDA 510(k)
FDA Class 1 ·Dental

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 23, 2023

BD PHASEAL¿ INJECTOR LUER LOCK N35C

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code ONG·December 1, 2017

CONTOUR® NEXT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 5, 2025

CONTOUR® NEXT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·February 6, 2026

DA VINCI SI SURGICAL SYSTEM

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·November 4, 2014

ADJ PIN COLLET 2.0-3.2MM

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·August 16, 2011

EON MINI

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 10, 2013

CONTOUR® NEXT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 21, 2025

CONTOUR® NEXT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·January 7, 2025

CONTOUR® PLUS ELITE

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 3, 2025

CONTOUR® PLUS ELITE

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 15, 2025

CONTOUR® NEXT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·February 20, 2025

BD PHASEAL¿ CONNECTOR LUER LOCK (C35)

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·November 13, 2019

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 23, 2023

MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

FDA Enforcement
Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014