13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z))
FDA 510(k)
FDA Class 2
·Cardiovascular
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668113868·ROBINS ANTERIOR CHAMBER CANNULA, 30GA
devemed
FDA UDI
devemed GmbH·04061644038602·Suction cannula Ø 1.5mm | 20.0cm
110° | with sl...
Reicodent
FDA UDI
devemed GmbH·04061644061587·Suction cannula Ø 1.5mm | 20.0cm
110° | with sl...
The VersaJet II Hydrosurgery System
FDA 510(k)
FDA Class 2
·General Hospital
LAPAROSCOPIC COMPRESSION ANASTOMOSIS CLIP (LAPCAC)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CLINITEK STATUS+
FDA Adverse Event
SIEMENS HEALTHCARE DIAGNOSTICS·Product code JIL·May 16, 2016
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE INC.·Product code CHL·March 4, 2025
STYLE 120 SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·July 2, 2025
U0707 TINA SINGLE PUMP NIBPLCD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKP·November 21, 2008
EPIC DR
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 11, 2011
BIPOLAR LEAD ADAPTOR - 3.2MM CONNECTOR
FDA Adverse Event
Malfunction
·GREATBATCH MEDICAL·Product code DTD·July 18, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025