9 results
·
33ms
·
Sources: EU EUDAMED, US FDA
OBJECTIVE REFRACTOR
FDA 510(k)
FDA Class 1
·Ophthalmic
Synergy
FDA UDI
Rmo, Inc.·00885797375872·COLUMBIA SYN ROTH 022 HK2345
ACUMED
FDA UDI
Acumed LLC·10806378091087·4.5mm Cannulated Countersink
ZOLL M SERIES NIBP OPTION, MODEL MSERIES NIBP OPTION
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNTHETIC POWDER FREE (PINK) VINYL PATIENT EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CALI·Product code KDI·May 9, 2014
M2A-MAGNUM MODULAR HEAD 50MM HEAD DIAMETER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·October 23, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·August 16, 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