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

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HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR

FDA 510(k)
FDA Class 2 ·Physical Medicine

LEONE SPA

FDA UDI
LEONE SPA·08033707065630·INTRAORAL ELASTICS 2,5 oz 1/8" brown

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690189626·6+ FEMUR / 7 TIBIA TRIALS INSTRUMENT PAN

N/A

FDA UDI
BIOMET MICROFIXATION, INC·00841036027025·

InTess Lumbar Cage

FDA UDI
Kalitec Direct LLC·B07312K0101080·Distractor, Smooth Paddle, 8mm

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690189619·AK3 6+ Femur/7 Tibia Instrument pan insert

TiWAVE L Lumbar Cage System

FDA UDI
Kalitec Direct LLC·B07323K0101080·Distractor, Smooth Paddle, Lordotic, 8mm

USS-LINE EXTENSION

FDA 510(k)
FDA Class 2 ·Orthopedic

RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100

FDA 510(k)
FDA Class 1 ·Ear, Nose, Throat

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·February 12, 2026

THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

FDA Adverse Event
Malfunction ·THORATEC CORPORATION·Product code DSQ·October 10, 2024

UNKNOWN LINER

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JDI·February 10, 2015

CURRENT PLUS VR, DF4 CONNECTOR

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 2, 2013

PANORAMA CENTRAL STATION WITH TELEMETRY

FDA Adverse Event
Malfunction ·MINDRAY DS USA, INC.·Product code MHX·August 18, 2014

HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 16, 2011

BD ALARIS¿ EXTENSION SET

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·November 24, 2021

UNSPECIFIED BD INFUSION SET

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·December 22, 2022

Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

FDA Enforcement
Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024