11 results
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26ms
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Sources: EU EUDAMED, US FDA
J2 MICROSCOPE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112618·BARRON CORNEAL PUNCH 7.5MM
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122826·K-WIRE - DOUBLE TROCAR 0.7mm DIA x 150mm
LIQUIBAND DUAL, MODEL LBD 001
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AEGIS & AEGIS II SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SYMBIQ 3.13 SINGLE C
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 2, 2014
LIGASURE V SEALER/DIVIDER
FDA Adverse Event
Malfunction
·COVIDIEN LLC (SHANGHAI)·Product code GEI·November 28, 2012
ASR ACETABULAR IMPLANT 62
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·November 10, 2010
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 10, 2025
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
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