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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VISION-TECH YZ SLIT LAMP, MODEL 66
FDA 510(k)
FDA Class 2
·Ophthalmic
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033190·Baltic Denture System BDLoad BDLoad Sm6 PLSEbm...
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120331901·Diamond, round, Micro Prep, fine grit, red ring
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197393072·Jansen-Middleton Nasal Punch
3x13mm...
ALPHATEC
FDA Adverse Event
ALPHATEC MFG INC. AKA NEXMED INC·Product code HWC·February 26, 2004
E.CAM COMPUTER / E.SOFT WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
EN BLOC BIOPSY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 7, 2025
TOTAL CARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 1, 2013
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·February 28, 2011
MERCI RETRIEVER L6
FDA Adverse Event
Malfunction
·CONCENTRIC MEDICAL, INC.·Product code NRY·April 23, 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