17 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Lumbar Spine Truss System Plating Solution (LSTS-PS)
FDA 510(k)
FDA Class 2
·Orthopedic
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·04049958003141·1000 micron Holmium Laser Fiber Cable, Single U...
Oph. Cystotomes
FDA UDI
KATENA PRODUCTS, INC.·00841668113684·CYSTOTOME FORMED 27GA
Oph. Cystotomes
FDA UDI
KATENA PRODUCTS, INC.·00841668113691·CYSTOTOME FORMED 25GA
Oph. Cystotomes
FDA UDI
KATENA PRODUCTS, INC.·00841668113660·CYSTOTOME STRAIGHT 25GA
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code QJR·September 18, 2020
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code QJR·September 11, 2020
CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SEEDNET, MODEL EP6T5, EP5E5
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 2, 2007
BD MAX SYSTEM, BD MAX INSTRUMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code OOI·September 3, 2020
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·October 23, 2014
DIAMOND 3
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DXY·August 11, 2011
ENDOPATH** XCEL* BLADELESS TROCAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·July 2, 2013
TRIDENT 10° X3 INSERT 36MM ID
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·June 6, 2016
MAZOR X SYSTEM
FDA Adverse Event
Malfunction
·MAZOR ROBOTICS LTD·Product code OLO·January 1, 2026
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