17 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MCKESSON ANESTHESIA CARE
FDA 510(k)
FDA Class 2
·Anesthesiology
COMPREHENSIVE SHOULDER SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304462632·
Comprehensive® Shoulder System
FDA UDI
Biomet Orthopedics, LLC·00887868267802·
ACHILLES
FDA 510(k)
FDA Class 2
·Radiology
SSA-770A, APLIO ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
EXTENSION SET WITH T-CONN. SL
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code FPA·October 3, 2013
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN·Product code BTS·May 9, 2013
SHUNT SENSOR SYS500
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·September 17, 2014
SELOX JT 53
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVZ·May 24, 2011
COMPREHENSIVE REVERSE HUMERAL TRAY 44MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWS·March 17, 2017
Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long Item Number: 113633
FDA Recall
Terminated
·Biomet, Inc.·Product code MBF·January 7, 2022
Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long Item Number: 113633
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·March 2, 2022
Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 21, 2018
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021