10 results
·
21ms
·
Sources: EU EUDAMED, US FDA
MICROMEDIC AUTOMATIC DILUTER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACUMED
FDA UDI
Acumed LLC·10806378043376·4.0mm Hex Impact Screw Extractor
iNSitu™ Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127026706·Shortened Dual Taper Broach, Size 6
SYNCHRON SYSTEMS AMPHETAMINE REAGENT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ALATECH POWDERED LATEX PATIENT EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
CONSERVE(R) FEMORAL RESURFACING HEAD
FDA Adverse Event
Injury
·MICROPORT ORTHOPEDICS INC.·Product code KXA·May 8, 2014
ASR ACETABULAR CUPS 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·October 22, 2012
RESTORE ADVANCED RECHARGEABLE
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·August 12, 2010
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022