27 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Unimicro Veress Needle
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NA
FDA UDI
MAKO SURGICAL CORP.·00848486018221·PIN MAT 8.9 cm x 19.1 cm
Oticon
FDA UDI
Oticon A/S·05707131285751·NERA2, RITE 312 WL TC
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100028·BLUMENTHAL SPECULUM X-HEAVY
Trial Cage 20deg 18M
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215066710·
T-Handle
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215041199·
LNOPV AD-L AND PD-L OXIMETRY SENSORS
FDA 510(k)
FDA Class 2
·Cardiovascular
MODEL PM3030
FDA 510(k)
FDA Class 2
·Neurology
Ontrak
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522129230·CUFF,ABP,ADULT M,24-32CM/9-13IN,NO LTX
OnTrak
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522102240·CUFF,ABP,ADLT,24-32CM/9-13IN,NO LTX,QK DISC/LUER
Spacelabs
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522129599·CUFF,ABP,ADULT M,24-32CM/9-13IN,NO LTX
Bone marrow aspiration biopsy
FDA UDI
Möller Medical GmbH·04260277173210·
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 12, 2025
LNOP MP12 PATIENT CABLE
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·May 15, 2015
Widex
FDA UDI
Widex A/S·05706069787078·WIDEX EVOKE E-FM (Pearl white ) 100, RC coil
Widex
FDA UDI
Widex A/S·05706069901351·WIDEX EVOKE E-FP (Pearl white ) 100, Telecoil, ...
Widex
FDA UDI
Widex A/S·05706069901092·WIDEX EVOKE E-FA (Pearl white ) 100, Telecoil, ...
Widex
FDA UDI
Widex A/S·05706069923568·WIDEX MOMENT MBB3D 100 (Pearl white)
SPACELABS ADULT AMBULATORY BLOOD PRESSURE CUFF
FDA Adverse Event
Injury
·SPACELABS HEALTHCARE INC.·Product code DSI·February 26, 2015
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 7, 2014