20 results
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25ms
·
Sources: EU EUDAMED, US FDA
MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES, SURGICAL INSTRUMENTS USED DURING ENDOSCOPIC PROCEDURES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Barco
FDA UDI
Barco NV·05415334029415·MDFC-8232 3HB
AQUASOFT ALL-DAY & ALL-DAY T (HIOXIFILCON A) DAILY WEAR CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
PRIVATAN HOME TANNING CENTER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HEARTSTART MRX-EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 13, 2014
SUREFIX
FDA Adverse Event
Injury
·MPRI·Product code DTB·February 9, 2013
EASYTRAK 3
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·January 7, 2011
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DXC·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DXC·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
SELDRILL-SCHANZSCR Ø5 L200/80 SST
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
SELDRILL-SCHANZSCR Ø5 L200/80 SST
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS ULNA POR; DISC SEG ULNA POR; and Custom devices Item Nos. 114754 114755 114744 114745 114704 114705 114756 114757 114714 114715 114746 114747 114706 114707 114758 114759 114716 114717 114748 114749 114708 114709 114718 114719 CP561429 CP561430 CP561431 CP561432 CP561442 CP561449 CP561488 CP561489 CP561709 CP561710 CP561714 CP561715 PM555203 Product Usage: Total Elbow Replacement
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019
Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013