13 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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VIZILITE-BLUE ORAL EXAM KIT
FDA 510(k)
FDA Class 1
·Dental
Intraoral Yellow Tips 100-Pack
FDA UDI
DEN-MAT HOLDINGS, LLC·00359883002558·Dental restorative material canula, single-use
Intraoral Yellow Tips (100PK)
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172019156·Dental restorative material canula, single-use
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091033033·Baltic Denture System BDLoad ↓ Lw6 PLSEum4DFl C...
INSTANT-VIEW Methamphetamine (500) Urine Cassette Test
FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·10796918000344·INSTANT-VIEW Methamphetamine (500) Urine Casset...
HORICO
FDA UDI
Hopf, Ringleb & Co. GmbH & Cie.·EHORFG0330332·Rotary diamond instrument
SCAPHIX, STAPLE, FIXATION, BONE
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO: HL168W TOUCH SCREEN
FDA 510(k)
FDA Class 2
·Cardiovascular
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 3, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·March 29, 2011
FORCE FX-C GENERATOR
FDA Adverse Event
Malfunction
·COVIDIEN LP (VALLEYLAB)·Product code GEI·April 22, 2008
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024