22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HS Diam. Burr, Ø2.0x70, 80k
FDA UDI
Bien-Air Surgery SA·17630055507003·
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100552821·IN-OVATION® C EURO 022 U 5-5/L 3-3 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100552811·IN-OVATION® C EURO 022 U5-5/L3-3 CS HK
N/A
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100551921·In-Ovation C/R RNC/BASE/EURO 018 UL5-5 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100551821·IN-OVATION® C EURO 018 U5-5/L3-3 CS-BC HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100551811·IN-OVATION® C EURO 018 U5-5/L3-3 CS HK
QUANTA SYSTEM S.P.A.
FDA Adverse Event
Malfunction
·QUANTA SYSTEM, S.P.A.·Product code GEX·December 21, 2012
SAUFLON MULTI LENS CARE SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE)
FDA 510(k)
FDA Class 1
·General Hospital
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970072·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970102·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970089·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970119·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970096·
CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·October 19, 2022
COULTER® AC *T DIFF 2 ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·May 8, 2013
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Death
·BAXTER HEALTHCARE CORPORATION·Product code FKX·September 19, 2014
UNIVERSAL FEM SLV FUL POR 46MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·May 17, 2011
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012