7 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PULPDENT 2.5% NITRIC ACID ETCHANT
FDA 510(k)
FDA Class 2
·Dental
Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets
FDA 510(k)
FDA Class 2
·General Hospital
US-100 PORTABLE ULTRASOUND THERAPY UNIT
FDA 510(k)
FDA Class 2
·Physical Medicine
ALTRX +4 NEUT 36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·July 22, 2015
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·January 23, 2013
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV·Product code FNL·November 30, 2010
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024