16 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DISPOSABLE SKIN RETRACTOR
FDA 510(k)
FDA Class 2
·Neurology
ACUMED
FDA UDI
Acumed LLC·10806378047060·Large Pointed Malleable Retractor
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209119080·KIT, HEADREST w' COMBAT GAUZE LE - BLK
Life Instruments
FDA UDI
Life Instrument Corporation·M9307801151310·Bayonet BiPolar Forceps 1.5mm Non-Stick ANG
COMPUMEDICS NEUVO
FDA 510(k)
FDA Class 2
·Neurology
ELECTROSURGICAL ELECTRODE FAMILY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PROFILE 8 FR. 40 CC. IAB WITH ACCESSORIES-DOMESTIC
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·September 23, 1998
CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code DYE·May 8, 2014
OTW, XK, 23CM, ST, SPLIT TIP, STANDARD KIT
FDA Adverse Event
Malfunction
·C. R. BARD, INC. (BASD)·Product code MSD·October 17, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·July 27, 2007
MITEK 4.5MM HEALIX ADVANCE BR ANCHOR WITH ORTHOCORD
FDA Adverse Event
Injury
·DEPUY MITEK·Product code MAI·July 9, 2015
Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument family and are intended for use in endoscopic manipulation and suturing.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·December 25, 2013
Philips Zenition 50, Model Number: 718096
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024