22 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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REMSTAR SE
FDA 510(k)
FDA Class 2
·Anesthesiology
DORMA 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 16, 2022
TISSUE FORCEPS RUSSIAN - 10"
FDA UDI
W.H. Holden, Inc.·D9281300770·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197024990·Scalpel Handle No.7
165mm,...
GISH TUBING AND CONNECTORS WITH GBS COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-FINGER SENSOR, MODEL T100A-090103
FDA 510(k)
FDA Class 2
·Cardiovascular
Widex
FDA UDI
Widex A/S·05706069671643·Widex EVOKE E-FA (Shocking pink ) 330, Telecoil...
Widex
FDA UDI
Widex A/S·05706069923315·WIDEX MOMENT MBB3D 330 (Shocking pink)
Widex
FDA UDI
Widex A/S·05706069553727·Widex UNIQUE U-FA (Shocking pink ) 330, Telecoi...
Widex
FDA UDI
Widex A/S·05706069972115·WIDEX MOMENT MBB2 330 (Shocking pink)
Widex
FDA UDI
Widex A/S·05706069556414·Widex D-FA P (Shocking pink ) Dream 330, Teleco...
Widex
FDA UDI
Widex A/S·05706069884401·WIDEX MOMENT MRR2D (Shocking pink ) 330, RC coi...
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·May 24, 2013
ADVIA 1800
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·September 30, 2014
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·June 16, 2011
UNK - MONO/POLYAXIAL SCREWS: USS
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKB·July 29, 2020
Single Shot Epidural Tray Catalog Number: 8417
FDA Enforcement
Class II
·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022
syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Model Number 11061670. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·May 4, 2022
syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM go.All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro and SOMATOM X.cite Material Numbers: 11061620 11061628 11061630 11061640 11061660 11061670
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·September 22, 2021
Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017