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

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ValvuloPro Valvuloplasty Balloon Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

PROXIMATE ILS CIRCULAR STAPLERS

FDA Adverse Event
Malfunction ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KOG·June 13, 2006

FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK

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

DISPOSABLE POWDER FREE VINYL EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 29, 2025

ANIMAS VIBE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·November 10, 2014

FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 25, 2008

VERSACARE BED

FDA Adverse Event
Malfunction ·HILL-ROM INC.·Product code FNL·July 17, 2013

PKG, 5MM MULTI-FUNCTION PEEK HANDLE, P/N 0250181106 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

FDA Enforcement
Class II ·Terminated·Stryker Endoscopy·December 24, 2014

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018