15 results
·
36ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software
FDA 510(k)
FDA Class 2
·Cardiovascular
OsteoMed
FDA UDI
OSTEOMED LLC·00845694027458·3.0mm X 28mm Cannulated Headless Screw
OsteoMed
FDA UDI
OSTEOMED LLC·00845694069427·Cannulated 3.0 x 28mm Headless Screw Sterile Qty 5
133 INCH X 17.2, 60 DROP PRIMARY, 2 BRAVO24, 2 102, 24 HR USE ONLY
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code LHI·June 8, 2016
VENOWAVE MODELS VW5-6, VW5-10, VW5-20 AND VW5-30
FDA 510(k)
FDA Class 2
·Cardiovascular
EEVATM PETRI DISH
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
FDA Adverse Event
Malfunction
·HAMILTON BONADUZ AG·Product code MMH·July 23, 2011
11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSB·June 17, 2013
STERRAD 100S STERILIZER
FDA Adverse Event
Malfunction
·ADVANCED STERILIZATION PRODUCTS·Product code MLR·September 19, 2008
PROTECT SLEEVE 11.5/9 L178 F/AFN
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code FZX·December 1, 2014
PROTECT SLEEVE 11.5/9 L178 F/AFN
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code FZX·December 1, 2014
PROTECT SLEEVE 11.5/9 L178 F/AFN
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code FZX·December 1, 2014
PROTECT SLEEVE 11.5/9 L178 F/AFN
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code FZX·December 1, 2014
BD ULTRA FINE¿ PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·January 31, 2022
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022