15 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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V SET
FDA 510(k)
FDA Class 2
·General Hospital
INTELLIJET
FDA UDI
Smith & Nephew, Inc.·00885554007060·SOD INTLJT CANN RTBL WITH VLV FOR
...
3M™ Unitek™
FDA UDI
3M COMPANY·30605861028456·3M™ Unitek™ Stainless Steel First Permanent Mol...
MAXBRAID PE
FDA UDI
TELEFLEX INCORPORATED·04026704601684·Blue Co-braid Polyethylene Size 2-0 24" AT-2 Ne...
MAXBRAID PE
FDA UDI
TELEFLEX INCORPORATED·14026704601681·Blue Co-braid Polyethylene Size 2-0 24" AT-2 Ne...
TELEFLEX
FDA UDI
TELEFLEX INCORPORATED·54026704601689·Blue Co-braid Polyethylene Size 2-0 24" AT-2 Ne...
RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E
FDA 510(k)
FDA Class 2
·Immunology
SUNMAX ENTERPRISE SHANGHAI CO. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS
FDA 510(k)
FDA Class 1
·General Hospital
SPOTSKAN
FDA UDI
SKANRAY TECHNOLOGIES LIMITED·18904269450318·Multi-Parameter Spot Check Device
PHILIPS INFORMATION CENTER
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code MHX·June 19, 2014
DIALYSIS IMPLANTED CATHETER
FDA Adverse Event
Malfunction
·C. R. BARD INC. (BASD)·Product code MSD·October 26, 2010
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·January 7, 2013
ADVIA Centaur CP System, Catalog/Part Number 086-A001. Automated Immunoassay Analyzer. --- Classification of the Device: Under 21 CFR, Part 862.2160, the ADVIA Centaur CP is a discrete photometric chemistry analyzer for clinical use and is classified as a Class I (general control) device. --- The ADVIA Centaur CP is part of Bayer's Immunochemistry analyzer family, which also includes the ADVIA Centaur and the ACS:180. Based on FDA guidance for deciding when regulatory filings are warranted for device modifications, as well as, the FDA Instrument Family and Replacement Reagent Policy Guidance, Bayer determined that the changes associated with the ADVIA Centaur CP did not affect the safety and effectiveness of the predicate device (ACS:180) and therefore no device modification 510(k) was warranted. The ADVIA Centaur CP instrument uses the same reagents as the ADVIA Centaur. The ACS:180 was cleared by FDA under 510(k) # K902336, and the ADVIA Centaur was cleared by FDA under 510(k) # K971418. The ADVIA Centaur CP system was released for sale in November 2005 and distribution of these systems began at that time. All ADVIA Centaur CP Systems are impacted. There is no expiration date for these systems.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics·Product code JJE·November 9, 2006
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
ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: 11653093, running software version VA10x with DICOM SR Cardiac option, from VB10A to VB10G, VB11A, VB11B, VB30B and VB30C
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·May 1, 2024