14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AN85/AN86 EO Indicators
FDA 510(k)
FDA Class 2
·General Hospital
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100127·KRATZ-BARRAQUER SPECULUM RIGHT EYE
HNM Women Care
FDA UDI
HNM STAINLESS, LLC.·00812171027911·PESSARY, CUP #5, W/O SUPPORT, 75/43mm
VANCOUVER BIOTECH HUMAN CARDIAC TROPONIN I IMMUNOASSAY TEST KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OPTOS LIMITED PANORAMIC 200CAF
FDA 510(k)
FDA Class 2
·Ophthalmic
SEDLINE KIT
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code MWI·December 7, 2017
SEDLINE KIT
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code MWI·January 8, 2017
BD ULTRASAFE PLUS¿ 2.25 ML PASSIVE NEEDLE GUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON HUNGARY KFT (BD)·Product code FMF·January 14, 2025
SEDLINE KIT
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code GWQ·July 21, 2017
PENUMBRA COIL 400
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code KRD·June 6, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008
10 ML BD¿ SLIP TIP SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 5, 2017
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024