572 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OC-Auto
FDA UDI
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC·00816917023151·Personal Use Kit OC-Auto, Custom Kit for Hancoc...
ACUMED
FDA UDI
Acumed LLC·10806378070150·8mm X 280mm Special Polarus® Plus Rod
ACUMED
FDA UDI
Acumed LLC·10806378070136·8mm X 240mm Special Polarus® Plus Rod
ACUMED
FDA UDI
Acumed LLC·10806378070129·8mm X 220mm Special Polarus® Plus Rod
ACUMED
FDA UDI
Acumed LLC·10806378070143·8mm X 260mm Special Polarus® Plus Rod
ACUMED
FDA UDI
Acumed LLC·10806378070112·8mm X 200mm Special Polarus® Plus Rod
HRH-127 HEAD ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
HRH-63 HEAD ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
HRH-127-ALLEGRA HEAD ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
HRH-127-8 HEAD ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
HRH-63-8 HEAD ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
UNSPECIFIED BD INFUSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS S.A. DE C.V.·Product code FPA·August 26, 2025
VACUETTE® TUBE 5 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 13X100 GOLD CAP-GOLD RING
FDA Adverse Event
Malfunction
·GREINER BIO-ONE NA INC.·Product code JKA·March 2, 2026
BD ALARIS SMARTSITE PUMP INFUSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS S.A. DE C.V.·Product code FPA·October 15, 2025
HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
UNSPECIFIED BD INFUSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS S.A. DE C.V.·Product code FPA·July 23, 2024
CADD 50ML/100ML MEDICATION CASSETTE RESERVOIRS WIT
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·January 18, 2022
AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation, Rx only. Used as a nasal packing following intranasal surgery to absorb blood and other fluids in the nasal cavity.
FDA Enforcement
Class II
·Terminated·Summit Medical, Inc.·December 23, 2015
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·February 26, 2024
UNSPECIFIED BD¿ INFUSION SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·January 10, 2022