25 results
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21ms
·
Sources: EU EUDAMED, US FDA
MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780432692·Integra® Jarit® Universal Bandage Scissors, Wit...
O-ARM IMAGING SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC (LITTLETON)·Product code OXO·November 19, 2024
HS Stand. Burr, Ø2.3x70, 50k
FDA UDI
Bien-Air Surgery SA·07630055506849·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450456767·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450292495·
House Brand Dentistry
FDA UDI
Frontier Dental Supply Inc·00810132809699·HSB - 6" x 11" - NYLON Self-Sealing Sterilizati...
Cordella Data Analysis Platform
FDA UDI
Endotronix, Inc.·00850008997051·The Cordella Pulmonary Artery Sensor System is ...
Integra
FDA UDI
Provision·B504GS1005430·
Chromatography Bfr B, 01-00543, 200L bag
FDA UDI
Lonza Walkersville, Inc.·00840075402701·
CONTEMPRO-MIST
FDA 510(k)
FDA Class 2
·Anesthesiology
KM-30 TENS ELECTRODE
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 30, 2024
Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
FDA Enforcement
Class II
·Ongoing·Merit Medical Systems, Inc.·August 20, 2025
SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER WITH AMC THROMBOSHIELD
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DQE·May 8, 2013
TERUMO PERFUSION SYSTEM 8000
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code JOR·May 13, 2011
R. WOLFE - CORD
FDA Adverse Event
Malfunction
·R. WOLFE·Product code JOS·August 5, 2008
Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code PPD·June 5, 2025
TEMA ELBOW
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A·Product code JDC·January 2, 2026
BLUE LINE ULTRA PERCUTANEOUS TRACHEOSTOMY KIT WITHOUT FORCEPS, 8.0MM - 100/543/0
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JOH·November 9, 2018