11 results
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34ms
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Sources: EU EUDAMED, US FDA
INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
ERA 2.2mm IMP 0' Micro Head 13X3 MM Acid Etch, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549115462·Designed for both transitional and long-term de...
BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·TRI-TECH FORENSICS, INC.·Product code JKA·July 29, 2025
BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·TRI-TECH FORENSICS, INC.·Product code JKA·July 29, 2025
BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·TRI-TECH FORENSICS, INC.·Product code JKA·July 29, 2025
DYNASTY BIOFOAM SHELL
FDA 510(k)
FDA Class 2
·Orthopedic
RHS ACETABULAR COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010
GEL FACE MASK
FDA Adverse Event
Malfunction
·SMITH & NEPHEW OKLAHOMA CITY MANUFACTURING SITE·Product code BZD·January 18, 2013
COBAS 6000 E601 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·July 9, 2014
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