13 results · 29ms · Sources: EU EUDAMED, US FDA

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CORIN THOMPSON PROSTHESIS, MODIFICATION

FDA 510(k)
FDA Class 2 ·Orthopedic

KARATS MULTIPURPOSE SOLUTION

FDA 510(k)
FDA Class 2 ·Ophthalmic

MERIDIAN

FDA 510(k)
FDA Class 2 ·Dental

ATTUNE FEM NAR POR PS LT SZ 6

FDA Adverse Event
Injury ·DEPUY IRELAND - 9616671·Product code MBH·March 26, 2024

HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE

FDA Adverse Event
Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·August 11, 2021

ADVANCE BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·April 15, 2014

INRATIO2

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·December 7, 2010

ASR UNI FEMORAL IMPL SIZE 43

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·January 28, 2013

PLEURX DRAINAGE KIT 500ML 10/CS

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code DWM·July 25, 2025

PLEURX DRAINAGE KIT 500ML 10/CS

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code DWM·December 24, 2024

PLEURX DRAINAGE KIT 500ML 10/CS

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code DWM·December 24, 2024

Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

FDA Enforcement
Class II ·Ongoing·GE Medical Systems, LLC·December 28, 2022

TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

FDA Enforcement
Class II ·Terminated·Synthes, Inc.·May 20, 2015