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

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InterForm Cervical Interbody Cage System

FDA 510(k)
FDA Class 2 ·Orthopedic

OsteoMed

FDA UDI
OSTEOMED LLC·00842528102121·4.2 mm Cannulated Proximal Cortex Drill, Standa...

OsteoMed

FDA UDI
OSTEOMED LLC·00845694043007·1.6mm x 8mm Screw

Orthocryl®

FDA UDI
DENTAURUM GmbH & Co.KG·J011161608000·Orthocryl® Disco glitter, silver

OsteoMed

FDA UDI
OSTEOMED LLC·00842528108260·4.2 mm Cannulated Proximal Cortex Drill, Standa...

VACUTRON

FDA UDI
Allied Medical, LLC·00026072009376·INTERMITTENT SUCTION REGULATORS

MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER

FDA 510(k)
FDA Class 2 ·Radiology

BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS

FDA 510(k)
FDA Class 2 ·Dental

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

I-STAT TROPONIN (CTNI) CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code MMI·August 5, 2017

ASKU

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 3, 2026

ASKU

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 3, 2026

CLEARLINK CONTINU-FLO SOLUTION SET

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·December 6, 2021

CARELINK

FDA Adverse Event
Malfunction ·MEDTRONIC, INC.·Product code KRG·October 10, 2014

POWERPORT ISP M.R.I. IMPLANTABLE PORT

FDA Adverse Event
BARD ACCESS SYSTEMS·Product code LJT·June 5, 2013

EASYTRAK 2

FDA Adverse Event
Malfunction ·CPI - DEL CARIBE·Product code OJX·July 14, 2011

Jackson-Pratt Silicone Round Drain, 10FR. 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

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