17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VISIOFOCUS
FDA 510(k)
FDA Class 2
·General Hospital
Medline Industries, Inc.
FDA UDI
MEDLINE INDUSTRIES, INC.·10889942135257·NS 1019 DRAPE KIT
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113652·PS-C Insert, Size 4 x 12mm
Vu cPOD™
FDA UDI
Seaspine Orthopedics Corporation·10889981039356·Implant Non-Tapered 12x14x12mm (Non-Strut)
K2M General Instruments
FDA UDI
VB Spine LLC·10888857553934·Parallel Trial Size 11x30x6 mm
BD LUER-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·July 29, 2024
BD LUER-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 30, 2024
VISTA DIGITAL OPTHALMOSCOPE
FDA 510(k)
FDA Class 2
·Ophthalmic
FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
IOLMASTER 500
FDA Adverse Event
Malfunction
·CARL ZEISS MEDITEC AG (JENA)·Product code HJO·October 14, 2015
BD Q-SYTE CLOSED LUER ACCESS DEVICE
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FPA·September 16, 2024
COULTER® AC *T DIFF 2 ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·May 21, 2013
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·September 18, 2014
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 13, 2011
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult ClearSeal King LAD¿ Patient Size: 50-70kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012
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
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015