33 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS
FDA 510(k)
FDA Class 2
·Cardiovascular
PowerGlide Midline Catheter
FDA UDI
Bard Access Systems, Inc.·00801741038068·DOT PGlide 20G 8cm Full
Peripheral Catheter Insertion Kit
FDA UDI
Bard Access Systems, Inc.·00801741110573·DOT PFlex, 20G 8cm Full
EVO 2 ST
FDA UDI
DENTAL MANUFACTURING SPA·08056865012810·
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK1200110·Rod Gripper, 5.50mm Angled
ENDOSCOPIC CLIP SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENTEROSCOPY OVERTUBE, MODEL 00712140
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POWERGLIDE MIDLINE CATHETER
FDA Adverse Event
Malfunction
·BARD ACCESS SYSTEMS, INC.·Product code FOZ·September 8, 2014
Widex
FDA UDI
Widex A/S·05706069794427·Widex EVOKE E-FP (Tan silk ) 220, Telecoil, Vol...
Widex
FDA UDI
Widex A/S·05706069817799·Widex UNIQUE U-FM (Tan silk ) 220, RC coil
Widex
FDA UDI
Widex A/S·05706069806298·Widex EVOKE E-FA (Tan silk ) 220, Telecoil, Vol...
Widex
FDA UDI
Widex A/S·05706069807332·Widex EVOKE E-FM (Tan silk ) 220, RC coil
Widex
FDA UDI
Widex A/S·05706069817249·Widex UNIQUE U-FA (Tan silk ) 220, Telecoil, Vo...
Widex
FDA UDI
Widex A/S·05706069818147·Widex UNIQUE U-FP (Tan silk ) 220, Telecoil, Vo...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 16, 2025
VANG SSK INTLK FEM 65 RT
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·May 20, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 25, 2014
CAPTURE-R READY SREEN I AND II
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·June 10, 2011
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerGlide Midline Catheter Full Kit (20G) (8cm), PowerGlide Midline Catheter Maximal Barrier Tray (20G) (8cm), PowerGlide Midline Catheter Full Kit (20G) (10cm), The syringe is used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.
FDA Enforcement
Class II
·Terminated·Bard Access Systems·March 25, 2015
MONOSYN UNDYED 5/0 OR 6/0
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·June 23, 2021