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