19 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VE
FDA 510(k)
FDA Class 2
·Cardiovascular
Gyrus ACMI
FDA UDI
Gyrus ACMI, LLC·00821925016064·MCGEE PISTON SLIM .6 MM DIAMETER 4.25MM LENGTH ...
Suprasorb
FDA UDI
Huizhou Foryou Medical Devices Co., Ltd.·06940610115647·
Reef TH
FDA UDI
Seaspine Orthopedics Corporation·10889981201814·Interbody, 11mm x 40mm x 16mm, 15 deg
Reef TA
FDA UDI
Seaspine Orthopedics Corporation·10889981193829·Interbody, 11mm x 40mm x 16mm, 15 deg
Non-Shouldered Temporization Sleeve
FDA UDI
BICON, LLC·00813110024923·4.0mm Non-Shouldered Temporization Sleeve
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197540292·Caspar Rongeur upwards angled 5x14mm 160
mm
REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805
FDA 510(k)
FDA Class 2
·Cardiovascular
FREERIDER MODEL LUGGIE MODEL 168-4IT
FDA 510(k)
FDA Class 2
·Physical Medicine
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·November 11, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 14, 2023
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 22, 2023
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 6, 2020
ZIMMER SKIN GRAFT MESHER
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code FZW·May 29, 2013
SYNCHRON® SYSTEMS RHEUMATOID FACTOR (RF) REAGENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code DHR·June 25, 2011
VIBRANT SOUNDBRIDGE
FDA Adverse Event
Injury
·VIBRANT MED-EL HEARING TECHNOLOGY GMBH·Product code MPV·September 2, 2008
TRUE METRIX AIR
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·November 7, 2023
TRUE METRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·July 16, 2024
Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Number 58403-000). Intended for patients for whom the monitoring of continuous cardiac output is indicated for diagnostic and prognostic evaluation by a clinician in the hospital.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·May 16, 2018