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