12 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems
FDA 510(k)
FDA Class 2
·Microbiology
RIGIDFIX
FDA UDI
DEPUY MITEK, LLC·10886705003174·RIGIDFIX TIBIAL BTB STEP TROCAR, SHORT
INSTAFLO BOWEL CATHETER SYSTEM KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SOCRATES ROBOTIC TELEMONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 23, 2024
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·October 22, 2008
INFINITY DENTAL IMPLANT SYSTEM
FDA Adverse Event
Injury
·ACE SURGICAL SUPPLY CO.·Product code DZE·July 3, 2013
GORE
FDA Adverse Event
Injury
·W L GORE & ASSOCIATES·Product code NIP·March 28, 2008
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right, Sterile, Catalog # 504-02-64E-R, UDI (01)07613327012460(17)
FDA Enforcement
Class II
·Terminated·Howmedica Osteonics Corp.·May 27, 2020
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019