21 results · 21ms · Sources: EU EUDAMED, US FDA

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JACKSON LACRIMAL INTUBATION SET

FDA 510(k)
FDA Class 1 ·Ophthalmic

NUPRO® Prophylaxis Paste with Fluoride

FDA UDI
DENTSPLY INTERNATIONAL INC.·D0038012321·NUPRO® Prophy Paste, Mint, Fine, Single Box (20...

CODMAN®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780514916·CODMAN® Bipolar Irrigating Loop Cutting Forceps...

CODMAN MALIS

FDA UDI
Cerenovus, Inc.·10886704036098·CODMAN MALIS Bipolar Irrigating Loop Cutting Fo...

CODMAN

FDA UDI
Cerenovus, Inc.·10886704080565·CODMAN Bipolar Irrigating Loop Cutting Forceps ...

NAR Kit

FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209121892·KIT, MINI MEDIC - MTC - w' COMBAT GAUZE

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776139612·Malis Bipolar Irri., Fcp, Bayo, Ins, 8 3/4" tit...

PROBE LASER STD HANDLE CYCLOPHOT

FDA Adverse Event
Malfunction ·IRIDEX CORPORATION·Product code GEX·January 2, 2025

TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES

FDA 510(k)
FDA Class 2 ·Neurology

NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM 50 MICROGRAMS OR LESS

FDA 510(k)
FDA Class 1 ·General Hospital

BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·August 9, 2018

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 8, 2014

TECNIS 1-PIECE

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code HQL·October 23, 2012

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·May 28, 2015

Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·May 20, 2015

Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143. Used to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·May 7, 2014

Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma cameras intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·May 20, 2015

ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026