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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Disposable Surgical Face Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113561·IMPLANT BLADE 6.2MM (BX/5)
RR - UP - Commuter Passenger - zlb
FDA UDI
Certified Safety Manufacturing, Inc.·00766588024110·RR - UP - Commuter Passenger - zlb
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383513180·"An absorbent paper points is an endodontic pap...
COMBISON 301 PW ULTRASOUND SYSTEM AND TRANSDUCERS
FDA 510(k)
FDA Class 2
·Radiology
LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·October 8, 2008
UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·August 5, 2011
ARTICULEZE M HEAD 36MM -2
FDA Adverse Event
Injury
·8010379 DEPUY INTL., LTD.·Product code JDI·July 2, 2013
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·February 7, 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
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025