11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EMPHASYS Dual Mobility System
FDA 510(k)
FDA Class 2
·Orthopedic
OsteoMed
FDA UDI
OSTEOMED LLC·00845694021982·FPS 22mm Cannulated Phalanx Reamer
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573021925·OPTYC MBT CUS HK 0T +8A 022 UL
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code QFG·January 23, 2023
CORE PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SOLO-CARE PLUS MULTIPURPOSE SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE 0.5 ML
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code MEG·February 18, 2020
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 18, 2008
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·July 22, 2011
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·July 17, 2013
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239
FDA Enforcement
Class I
·Ongoing·Bard Peripheral Vascular Inc·March 12, 2025