11 results
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18ms
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Sources: EU EUDAMED, US FDA
KTP/532 SURGICAL LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011884029220·dentaform® Band, Tooth 46, Size 29/Roth 22
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011884029000·dentaform® Band, Tooth 46, Size 29
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011884029180·dentaform® Band, Tooth 46, Size 29/Roth 18
RESPIRATORY RESUSCITATION DEVICE
FDA 510(k)
FDA Class 1
·Anesthesiology
BIO-UREA
FDA 510(k)
FDA Class 1
·Microbiology
FEMTO LDV Z4
FDA Adverse Event
Other
·SURGICAL INSTRUMENT ENGINEERING AG·Product code OOE·June 13, 2014
TALENT THORACIC STENT GRAFT (CT)
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·October 14, 2010
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·December 21, 2012
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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