569 results · 23ms · Sources: EU EUDAMED, US FDA

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Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5

FDA 510(k)
FDA Class 2 ·Radiology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04047872673198·LEVAMED STABILI-TRI ANK SUP BLU R III

VARIAX

FDA UDI
Stryker GmbH·04546540540874·Screwdriver Blade, 1.2,Cross-Pin,Dental

Distal Ulna Plate

FDA UDI
I.T.S. GmbH·09120047296516·Distal Ulna Plate, 3-Hole, Right

FLEXI-SITE SP02 EAR SENSOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

LRT ATTACHMENT

FDA 510(k)
FDA Class 2 ·Dental

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 30, 2014

IVT DISPOSABLE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MALTA·Product code KPE·August 15, 2011

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 9, 2013

ONE TOUCH ULTRA

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·August 6, 2002

I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers. 1. I.T.S. DUL (Distal Ulna Locking) System, Distal Ulna Plate; Article Numbers: 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21234-4, 21235-4. 2. I.T.S. UOL (Ulna Osteotomy Locking) System, Ulna Osteotomy Plate; Article Numbers: 21231-6. 3. UOL (Ulna Osteotomy Locking) System, Cancellous Screw, Locking; Article Numbers: 37302-18, 37302-20.

FDA Enforcement
Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

CustMbite, Model Number CBT-SRS-UL

FDA Enforcement
Class II ·Ongoing·Dental Choice Holding Llc·August 10, 2022

INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code PKL·December 19, 2022

INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code PKL·June 9, 2022

INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code PKL·January 2, 2025

INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code PKL·June 30, 2022

INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code PKL·July 17, 2024

INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code PKL·September 12, 2024

INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC·Product code PKL·May 26, 2022

INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

FDA Adverse Event
Injury ·WILSON-COOK MEDICAL INC·Product code PKL·June 9, 2022