8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42
FDA 510(k)
FDA Class 1
·Microbiology
HEATER, OXIMETER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SPSMEDICAL SPORVIEW PA CULTURE SET
FDA 510(k)
FDA Class 2
·General Hospital
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 18, 2014
SMITH'S CADD CASSETTE
FDA Adverse Event
Injury
·SMITH'S MEDICAL·Product code FPA·October 18, 2010
6.0MM TI CANN MATRIX POLYAXIALSCREW 30MM THREAD LENGTH
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code NKB·December 20, 2012
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025