18 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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APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH
FDA 510(k)
FDA Class 2
·Cardiovascular
CHS
FDA UDI
Smith & Nephew, Inc.·03596010062413·AMBI COMPRESSION HIP SCREW SHT PLATE 5SL 120MM ...
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00812564031914·Basic Pack, UMMS
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·August 10, 2023
LEGEND POWER ADAPTER MODEL: 6475000
FDA 510(k)
FDA Class 2
·Neurology
JUMP START, MODEL 970300
FDA 510(k)
FDA Class 3
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 21, 2024
ZEPHYR XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·January 13, 2014
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 20, 2013
ALARIS PCA MODULE IV ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FPA·May 4, 2011
Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Number: 10848282
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019
Allura Xper FD20/20; Catalog numbers: 722038
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator. Used in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·March 20, 2013
Artis Q biplane, Model Number 10848282
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·February 26, 2014
Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 26, 2018
Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022
Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 22, 2018