13 results
·
21ms
·
Sources: EU EUDAMED, US FDA
BAKER DIAG. ULTRARATE CO2 REAGENT KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Bardia® Universal Catheter Insertion Tray
FDA UDI
C. R. Bard, Inc.·00801741051166·Bardia Universal Catheter Insertion Tray, 30 cc
Elite Orthopaedics
FDA UDI
Elite Orthopaedics, Inc.·00816591013998·OA Knee Brace, Single Upright, Right
ACUMED
FDA UDI
Acumed LLC·10806378091124·4.5mm Cannulated Tap
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776123888·Bayonet Bipolar Forceps, irrigating
Elite Orthopaedics
FDA UDI
Elite Orthopaedics, Inc.·00816591014001·OA Knee Brace, Single Upright, Left
MAICO MB 11 WITH BERAPHONE PROBE
FDA 510(k)
FDA Class 2
·Neurology
SLEEK OTW PTA CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
PLUM A+ DRIVER NEW 8
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 4, 2014
M2A-MAGNUM MODULAR HEAD SZ 50MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·October 23, 2012
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 16, 2010
SLEEK OTW PTA CATHETER
FDA Adverse Event
Injury
·CLEARSTREAM TECHNOLOGIES LTD.·Product code DQY·December 13, 2023
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022