16 results · 22ms · Sources: EU EUDAMED, US FDA

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STARBAND AND STARLIGHT

FDA 510(k)
FDA Class 2 ·Neurology

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613017743·K-Wire, Double Ended, Trocar Point, Diameter Si...

Fuji Cervical Plate System

FDA UDI
Altus Spine, LLC·B41711403531·53mm Level 3 Cervical Plate System - Fuji

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197382786·No-Scalpel Vasectomy Mini Fixator Ring- forcep...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197382779·No-Scalpel Vasectomy forceps 5", 12.5cm cvd. ,...

FLIGHT SOCK

FDA 510(k)
FDA Class 2 ·General Hospital

SPINEWAND SURGICAL DEVICE

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·October 3, 2014

ULTRACISION HARMONIC ACE

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 31, 2013

ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

FDA Adverse Event
Injury ·COOK, INC.·Product code MIH·June 16, 2011

HISTOACRYL FLEXIBLE PACK 5

FDA Adverse Event
Malfunction ·B. BRAUN SURGICAL SA·Product code MPN·February 11, 2020

GALAFLEX

FDA Adverse Event
Injury ·TEPHA, INC·Product code OOD·February 28, 2020

HISTOACRYL TRANSLUCENT 10 AMP OF 0.5 ML

FDA Adverse Event
Injury ·B. BRAUN SURGICAL SA·Product code MPN·February 26, 2020

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

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

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022