15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ORTHOMEND SOFT TISSUE MATRIX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Sklar®
FDA UDI
SKLAR CORPORATION·10649111180743·YANKAUER SUCTION TUBE 15"
Acapella One
FDA UDI
Choice Spine, LP·00840996151405·ACAPELLA,TRIAL,CX,NS,14X18X7
TISSUE MARKER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SCS CLARIS SPINAL SCREWS, TYPES V,G,E
FDA 510(k)
FDA Class 2
·Orthopedic
BD SYRINGE S2 NS 20ML
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·February 4, 2020
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 26, 2025
ATTAIN ABILITY
FDA Adverse Event
Injury
·MPRI·Product code OJX·April 22, 2013
ACCU-CHEK FLEXLINK PLUS
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code FPA·April 21, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 8, 2008
BD SYRINGE S2 NS 20ML
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·September 26, 2019
BD SYRINGE S2 NS 20ML
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code NGT·February 25, 2020
SYRINGE S2 NS 20ML
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·October 28, 2019
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023