9 results · 25ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Nunchaku

FDA 510(k)
FDA Unclassified ·Unknown

EMBRACE

FDA 510(k)
FDA Class 2 ·Radiology

VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100

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

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 8, 2024

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 24, 2025

S-ROM M HEAD 36MM +9

FDA Adverse Event
Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JDI·June 11, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 13, 2011

PROLIEVE THERMODILITATION KIT

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·September 12, 2008

Jackson-Pratt Silicone Round Drain, 15FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

FDA Enforcement
Class II ·Terminated·Cardinal Health 200, LLC·May 31, 2017