41 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M
FDA 510(k)
FDA Class 2
·Cardiovascular
SampLok® Adapter Cap Insert
FDA UDI
ITL ASIA PACIFIC SDN. BHD.·19555240400014·SampLok® Adaptor Cap Insert (an optional access...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450177792·
Biliary Drainage Tube
FDA UDI
OLYMPUS MEDICAL SYSTEMS CORP.·04953170046308·
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869687607·MOSS Pedicle Screw Inserter Star 20 cannulated,...
DIGITAL ULTRASOUND SCANNER
FDA 510(k)
FDA Class 2
·Radiology
MENTOR STERILE SALINE MAMMARY VOLUME SIZERS
FDA 510(k)
FDA Unclassified
·Unknown
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DRE·April 6, 2023
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 28, 2025
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 8, 2013
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 19, 2014
LEAD GENERAL
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code EZW·May 12, 2011
VERSACROSS ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 19, 2023
INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·November 22, 2010
Tracheostomy Tubes, Jackson Improved Short Stainless Steel with Adapter, item number 8100402 size 3,item number 8100040 size 4, item number 8100041 size 5, item number 8100229 size 6, item number 8100322 size 7, item number 8100374 size 8, item number 8100282 size 9, and item number 8100709 size10.
FDA Recall
Terminated
·Premier Dental Products Co·Product code JOH·August 5, 2004
VERSACROSS ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DYB·April 20, 2023
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 25, 2023
FORTRESS INTRODUCER SHEATH SYSTEM - 6FR, 45CM
FDA Adverse Event
Malfunction
·CONTRACT MEDICAL INTERNATIONAL GMBH·Product code DYB·November 30, 2015
Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7) Oxygen Tubing, Product Code 108MM
FDA Enforcement
Class II
·Terminated·ConvaTec, Inc·June 14, 2017
Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018