15 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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STAXX(R) SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Oticon
FDA UDI
Oticon A/S·05707131260529·RIA PRO, RITE 312 WL TC
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613025014·Metzenbaum Nelson Scissors, Super Cut, Curved, ...
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1671332070·
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code OVD·December 18, 2019
CLYDESDALE PTC SPINAL SYSTEM
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code MAX·October 17, 2019
SONO TAP, TUOHY SONO
FDA 510(k)
FDA Class 2
·Anesthesiology
JBAIDS Q FEVER DETECTION KIT
FDA 510(k)
FDA Class 1
·Microbiology
PROLITE MESH
FDA Adverse Event
Injury
·ATRIUM MEDICAL CORP.·Product code FTL·May 24, 2013
L9000 LIGHTSOURCE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code GCT·May 9, 2011
PATIENT RETURN GROUNDING PAD
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code ODR·August 22, 2008
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019
BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions.
FDA Enforcement
Class III
·Terminated·Becton Dickinson & Co.·October 17, 2018
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015