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

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CENTERVUE DIGITAL RETINOGRAPHY SYSTEM

FDA 510(k)
FDA Class 2 ·Ophthalmic

Endo Carry-On Procedure Kit

FDA UDI
MEDIVATORS INC.·00677964071720·The ENDO CARRY-ON Procedure Kit contains all of...

ACCU-CHEK ® GUIDE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIABETES CARE, INC.·Product code NBW·December 21, 2021

ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

REJUVENIQUE MODEL #RJV10

FDA 510(k)
FDA Class 2 ·Neurology

SEALING UNIT FROM 5MM TROCARS

FDA Adverse Event
Malfunction ·AESCULAP AG & CO KG·Product code GCJ·June 17, 2015

REDUCING CONVERTER 10/12MM TO 5MM

FDA Adverse Event
Malfunction ·AESCULAP AG & CO KG·Product code GCJ·June 17, 2015

AED PLUS

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 19, 2013

INFUSOR

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·September 19, 2014

SELOX ST 53

FDA Adverse Event
Malfunction ·BIOTRONIK SE & CO. KG·Product code NVZ·May 17, 2011

VASOPRESS DIGITAL MINI PUMP

FDA Adverse Event
Malfunction ·ZIMMER SURGICAL, INC.·Product code JOW·January 6, 2020

ETHIBOND EXTRA & EXCEL POLYESTER SUTURE

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAT·March 25, 2026

VASOPRESS DIGITAL MINI PUMP

FDA Adverse Event
Malfunction ·COMPRESSION THERAPY CONCEPTS, INC.·Product code JOW·February 18, 2020

VASOPRESS DIGITAL MINI PUMP

FDA Adverse Event
Malfunction ·COMPRESSION THERAPY CONCEPTS, INC.·Product code JOW·September 17, 2019

VASOPRESS DIGITAL MINI PUMP

FDA Adverse Event
Malfunction ·ZIMMER SURGICAL, INC.·Product code JOW·November 19, 2019

VASOPRESS DIGITAL MINI PUMP

FDA Adverse Event
Malfunction ·ZIMMER SURGICAL, INC.·Product code JOW·November 19, 2019

VASOPRESS DIGITAL MINI PUMP

FDA Adverse Event
Malfunction ·ZIMMER SURGICAL, INC.·Product code JOW·December 10, 2019

COBAS INTEGRA 400 PLUS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JGS·May 7, 2010

Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025

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