11 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950029846·BANDAGE ACE ELASTIC 4" N-STER L/F L/F 10RL/BOX
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033172·Baltic Denture System BDLoad BDLoad Mw6 PLSEbi...
INSTANT-VIEW Methadone Urine Cassette Test
FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·10796918000641·INSTANT-VIEW Methadone Urine Cassette Test
SMALL HIGH SPEED MOTOR DRILL SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 1, 2013
DEXTRUS 4135
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVZ·February 28, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·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