16 results · 36ms · Sources: EU EUDAMED, US FDA

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CUI ARTICULATED SILICONE CHIN

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

Brigade

FDA UDI
Nuvasive, Inc.·00887517961402·Brigade Lateral Trial, 14x34x24mm 12°

BOSS Instruments

FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515228900·Strut Pick, .50mm point ang 90deg, med, 6 1/2"

ALBUMIN

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

INTCO TAB ELECTRODE

FDA 510(k)
FDA Class 2 ·Cardiovascular

HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·August 11, 2021

V60 VENTILATOR

FDA Adverse Event
Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code MNT·June 30, 2014

UNKNOWN DEPUY FEMORAL

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·November 16, 2010

9600

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 14, 2012

HF-RESECTION ELECTRODE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023

HF-RESECTION ELECTRODE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023

STEALTHSTATION¿ S8 SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·August 29, 2024

HF-RESECTION ELECTRODE, LOOP, 22.5 FR., 0.35 WIRE, 12°

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code KNS·August 11, 2016

UNKNOWN

FDA Adverse Event
Injury ·OLYMPUS WINTER & IBE GMBH·Product code KNS·October 21, 2022

Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012