20 results · 23ms · 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.

VESOFLOW PLUS DVT COMPRESSION DEVICE

FDA 510(k)
FDA Class 2 ·Cardiovascular

KMEDIC

FDA UDI
TELEFLEX INCORPORATED·24026704265231·

UniTip Catheter

FDA UDI
Unisensor AG·07640172971406·

BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P

FDA 510(k)
FDA Class 2 ·Dental

BIOKNOTLESS RC ANCHOR

FDA 510(k)
FDA Class 2 ·Orthopedic

Kyocera Medical Technologies, Inc.

FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523106455·Porous Acetabular Cup System - Hemispherical Sh...

Trilogy®

FDA UDI
Zimmer, Inc.·00889024569836·

Trilogy®

FDA UDI
Zimmer, Inc.·00889024569812·

Trilogy®

FDA UDI
Zimmer, Inc.·00889024638402·

Trilogy®

FDA UDI
Zimmer, Inc.·00889024638396·

Trilogy®

FDA UDI
Zimmer, Inc.·00889024638389·

Trilogy®

FDA UDI
Zimmer, Inc.·00889024569829·

Trilogy®

FDA UDI
Zimmer, Inc.·00889024638419·

Trilogy®

FDA UDI
Zimmer, Inc.·00889024569843·

MEDICAL CHAIR & TABLE

FDA Adverse Event
Injury ·CHAMPION MANUFACTURING·Product code INO·March 28, 2012

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FKX·June 3, 2013

DEXTRUS 4135

FDA Adverse Event
Other ·BIOTRONIK SE & CO. KG·Product code NVZ·June 15, 2011

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 3, 2008

PKG, BLUNT FORCEPS, BLUNT, SERRATED, SPOON, P/N 0250080313. 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. 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

OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021