14 results · 23ms · Sources: EU EUDAMED, 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