9 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AMIZYME-HSV TYPES 1 & 2 TEST KITS
FDA 510(k)
FDA Class 2
·Microbiology
Endodontic Hand Instruments
FDA UDI
TULSA DENTAL PRODUCTS LLC·D71668425311·Ready•Steel K-FILE 025 31MM
EasyTouch
FDA UDI
MHC MEDICAL PRODUCTS, LLC·MHC18425311·
UPDATED SLIP UROLOGY INTRODUCER SHEATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
F1-Modular Pedicle Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·February 21, 2014
ASR UNI FEMORAL IMPL SIZE 51
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 21, 2012
ASR ACETABULAR CUPS 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·September 17, 2010
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