16 results · 24ms · Sources: EU EUDAMED, US FDA

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MFI-Cardiac

FDA 510(k)
FDA Class 2 ·Radiology

Ophthalmic Ring

FDA UDI
KATENA PRODUCTS, INC.·00841668100851·MCNEILL GLOBAL FIXATION RING MEDIUM

Ø3.5mm x 12mm Lateral Mass Screw with Set Screw

FDA UDI
XENCO MEDICAL LLC·B064XM21735121·Ø3.5mm x 12mm Lateral Mass Screw with Set Screw...

AFFIRM BREAST BIOPSY GUIDANCE SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

START JUNIOR

FDA 510(k)
FDA Class 1 ·Physical Medicine

PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAW·September 7, 2018

PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTP·September 7, 2018

TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code JEY·May 31, 2019

PLUM XLM W/DATAPORT

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·October 10, 2014

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 23, 2011

COBAS 311

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·June 17, 2013

WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code LZD·August 29, 2017

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HWC·June 3, 2016

EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoor Rx, Cx.PC.IN.SUM.BK.Rx; Martinez Black Cx Rx, Cx-3.PC.PT.MTZ.BK.Rx

FDA Enforcement
Class II ·Ongoing·Enchroma Inc·November 27, 2024

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025