13 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UCP MULTIPLE DRUG SCREEN TEST CUPS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108692495·Conical 2mm Straight Anatomic Abutment Ti Conca...
Genius Total Knee System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215023270·
Crescendo Meniscal Insert PS 13mm Size 2
FDA UDI
AMPLITUDE SAS·03701089525237·
PF2
FDA 510(k)
FDA Class 2
·Orthopedic
SAMSUNG 10DR IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 5, 2014
QUATTRODE LEAD WIDE SPACED, 30 CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 8, 2015
UNKNOWN
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·April 22, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008
4 MOTOR ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·April 21, 2011
Mammotome MammoStar Biopsy Site Identified, REF STAR1401
FDA Recall
Terminated
·Carbon Medical Technologies, Inc.·Product code NEU·December 16, 2022
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024