24 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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HomeSleepTest (HST, HST REM+)
FDA 510(k)
FDA Class 2
·Neurology
Genus Evo Universal Handle Assembly
FDA UDI
ADLER ORTHO SPA·08050507136919·Genus Evo Universal Handle Assembly
ORTHOFIX
FDA UDI
ORTHOFIX SRL·18059015375503·REVISION LOCKING SCREW L70.0MM D4.0MM
WIN System
FDA UDI
Biomet Orthopedics, LLC·00880304285712·
TALOS®-C HA
FDA UDI
MEDITECH SPINE, LLC·B167522407000·
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702818925·ELVAREX 3/KNEE HIGH/SLANT-OPEN TOE-ELEPHANTIASI...
ORTHOFIX
FDA UDI
ORTHOFIX SRL·18059015375008·REVISION LOCKING SCREW L70.0MM D4.0MM STERILE
SONTEC CAST SPREADER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896026933·SONTEC CAST SPREADER
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319722558·Deep Deaver Retractor, 1" wide, 7" working leng...
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code QFG·April 7, 2023
CONCENTRIC RETRIEVER X5, MODEL 90035; CONCENTRIC RETRIEVER X6, MODEL 90037
FDA 510(k)
FDA Class 2
·Cardiovascular
Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code QFG·April 7, 2023
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code QFG·April 7, 2023
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING·Product code LXH·September 9, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 10, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·July 22, 2013
OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic Xray images and volumetric reconstructions during diagnostic, interventional, and surgical procedures.
FDA Enforcement
Class II
·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024
OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
FDA Enforcement
Class II
·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024
GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·March 19, 2025