14 results · 20ms · Sources: EU EUDAMED, US FDA

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Gemini Bonded Sterilization Wrap

FDA 510(k)
FDA Class 2 ·General Hospital

K152468

FDA UDI
Shenzhen Vistar Medical Supplies Co.,Ltd.·96973521874184·Reusable NIBP cuff,Thigh,single tube, HP connector

KMEDIC

FDA UDI
TELEFLEX INCORPORATED·24026704284287·

Low Profile Acetabular Reamer 58

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215057619·

4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

LIV MEDICA CPR FACE MASK

FDA 510(k)
FDA Class 2 ·Anesthesiology

TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 19, 2018

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 27, 2024

PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code NRY·February 4, 2016

PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code NRY·December 1, 2015

CONSULTA CRT-D

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 7, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

S-ICD SYSTEM

FDA Adverse Event
Injury ·CAMERON HEALTH·Product code NVY·July 29, 2014

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023