13 results · 31ms · Sources: EU EUDAMED, US FDA

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ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

VR LUNG ELECTROSONOGRAPH

FDA 510(k)
FDA Class 2 ·Cardiovascular

COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET

FDA Adverse Event
Malfunction ·COOK INC·Product code LJS·December 19, 2017

CHARGING SYSTEM

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 5, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011

HYDRATOME RX SPHINCTEROTOME

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·September 15, 2008

TURBO-FLO SINGLE LUMEN CENTRAL VENOUS CATHETER SET

FDA Adverse Event
Injury ·COOK INC·Product code LJS·October 1, 2018

TURBO-FLO SINGLE LUMEN CENTRAL VENOUS CATHETER SET

FDA Adverse Event
Injury ·COOK INC·Product code LJS·October 1, 2018

ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020

ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020

5.0MM FLEXIBLE SHAFT

FDA Adverse Event
Malfunction ·SYNTHES BETTLACH·Product code HTO·May 8, 2015

Jackson-Pratt Silicone Flat Drain, 7mm, Full Ducts. 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