27 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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