19 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Tyece OTC TENS Device
FDA 510(k)
FDA Class 2
·Neurology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699588·GENUMEDI PSS BLUE, SIZE VI
OSS™ Orthopedic Salvage System
FDA UDI
Biomet Orthopedics, LLC·00880304239142·
AGXO
FDA UDI
Oticon A/S·05707131287106·H110V2, RITE 312 WL SIL AGXO
REZUM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·April 23, 2024
Patella Inlay Reamer Size 4
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215074258·
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962104460·NEATCUT BLADE, 5.5MM, COMPATIBLE W/SN
DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM
FDA 510(k)
FDA Class 2
·Dental
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962102473·DISPOSABLE ARTHROSCOPIC 5.5mm NEATCUT SHAVER BL...
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 31, 2013
CONQUEST PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·June 8, 2011
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
FDA Adverse Event
Injury
·BIOENTERICS CORP.·Product code LTI·September 4, 2008
SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·May 25, 2021
RELION PEN NEEDLES 4MM X 32 GAUGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022
RELION PEN NEEDLES 4MM X 32 GAUGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022
RELION PEN NEEDLES 4MM X 32 GAUGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FMI·December 12, 2022
C-QUR MOSAIC
FDA Adverse Event
Injury
·ATRIUM MEDICAL CORPORATION·Product code FTL·October 9, 2015
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012