16 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Amplatz Support Wire Guide with Apex Curve
FDA 510(k)
FDA Class 2
·Cardiovascular
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741714450·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674171445060·
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000878337·TRIAL 2171445 O25 IB 20MM 6 DEG 14X45
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169595361·TRIAL 2171445 O25 IB 20MM 6 DEG 14X45
ATRAMAT
FDA UDI
Internacional Farmacéutica, S.A. de C.V.·07500142068775·ATRAMAT SILK SURGICAL SUTURE BLACK USP 4-0 EP 1...
TERRAQUANT MQ2000 V.5 WITH THE TQ-1TENS
FDA 510(k)
FDA Class 2
·Physical Medicine
VITAL SIGNS MONITOR-VSM 6000 SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
TRULIANT PS CEM FEM PS CEM RIGHT SZ 4.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 15, 2024
VC10 PUMP, 115V
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC.·Product code HHK·January 2, 2025
INTERJECT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FCG·May 27, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 15, 2013
HEARTMATE II LVAD
FDA Adverse Event
Malfunction
·THORATEC CORP.·Product code DSQ·June 30, 2011
PK DISSECTING FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·October 14, 2014
TRU CC FEMORAL SIZE 1 LEFT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 15, 2025
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·October 27, 2021