19 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Multi-Link X2 ECG and SpO2 Adapter
FDA 510(k)
FDA Class 2
·Cardiovascular
Hysteroscopy obturator
FDA UDI
SOPRO-COMEG GmbH·04059082006420·
Hysteroscopy sheath
FDA UDI
SOPRO-COMEG GmbH·04059082032597·
Hysteroscopy sheath
FDA UDI
SOPRO-COMEG GmbH·04059082032573·
Hysteroscopy sheath
FDA UDI
SOPRO-COMEG GmbH·04059082006505·
Hysteroscopy sheath
FDA UDI
SOPRO-COMEG GmbH·04059082006451·
Hysteroscopy sheath
FDA UDI
SOPRO-COMEG GmbH·04059082006444·
Hysteroscopy sheath
FDA UDI
SOPRO-COMEG GmbH·04059082032559·
Hysteroscopy sheath
FDA UDI
SOPRO-COMEG GmbH·04059082032566·
Hysteroscopy sheath
FDA UDI
SOPRO-COMEG GmbH·04059082006475·
Hysteroscopy sheath
FDA UDI
SOPRO-COMEG GmbH·04059082006437·
Hysteroscopy obturator
FDA UDI
SOPRO-COMEG GmbH·04059082032542·
Hysteroscopy sheath
FDA UDI
SOPRO-COMEG GmbH·04059082032580·
FIR HEAT THERAPHY SYSYEMS
FDA 510(k)
FDA Class 2
·Physical Medicine
DYNAMIC ECG SYSTEM MODEL TLC5000
FDA 510(k)
FDA Class 2
·Cardiovascular
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 21, 2014
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·July 27, 2011
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·June 26, 2013
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 15 DEGREE LINER 22MM SZ C, REF 132-22-03 b. ACUMATCH 15 DEGREE LINER 28MM SZ D, REF 13-28-04
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022