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

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Epix Electrosurgical Probe with Smoke Evacuation

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

CARDINAL HEALTH

FDA UDI
Cardinal Health 200, LLC·10885425920242·STERILE ULTRASOUND PREP TRAY

NOVATION LPI PRIME FEMORAL STEM

FDA 510(k)
FDA Class 2 ·Orthopedic

PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD

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

TRUWAVE, VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·April 21, 2026

TRUWAVE VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code DXO·April 23, 2025

TRUWAVE VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code DXO·April 23, 2025

FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·April 2, 2020

TRUWAVE, VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·May 2, 2025

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·June 15, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 22, 2011

TOTAL ASR ACET IMP SIZE 54

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·October 15, 2014

TRUWAVE, VAMP PLUS

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES DR·Product code DXO·March 27, 2025

TRUWAVE, VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code KRA·November 11, 2025

TRUWAVE, VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·July 23, 2025

TRUWAVE, VAMP PLUS

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·November 26, 2025

CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L

FDA Enforcement
Class I ·Terminated·Smiths Medical ASD Inc.·October 27, 2021

Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377

FDA Enforcement
Class II ·Completed·Philips North America Llc·September 15, 2021