24 results · 31ms · Sources: EU EUDAMED, US FDA

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Kolplast Cervical Sample Collection Kit

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE

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

CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE,

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

STEM: AMISTEM H HA COATED STD STEM SIZE 5

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 5, 2020

AMISTEM H CEMENTLESS FEMORAL STEM SIZE 5 STD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 11, 2015

CLEARLINK PACLITAXEL SETS

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·February 2, 2024

ASKU

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 6, 2026

SEE H10

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 17, 2020

ASKU

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 3, 2026

ASKU

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 3, 2026

DUO-VENT CLEARLINK LUER ACTIVATED VALVE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·July 12, 2023

NI

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 23, 2017

COBAS E411 RACK SYSTEM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·June 8, 2013

TERUMO CDI 100 MONITOR

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTY·June 17, 2011

POLYFLUX LR CAPILIARY DIALYZER

FDA Adverse Event
Malfunction ·GAMBRO DIALYSATOREN GMBH·Product code MSF·September 4, 2008

NI

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 23, 2017

SPECIFIC DEVICE NOT REPORTED

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·August 21, 2024

Artis zee biplane, Model Number 10094141

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

Artis zee biplane, Model Number 10094141

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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