15 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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SAFYRE VS AND SAFYRE T
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496033691·PERSONALITY 140 SHEER, SIZE 2XXL, VISONE, GRADU...
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033691·Baltic Denture System BDLoad BDLoad ↓ Mm6 PLSEu...
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP300, BUP, BZD, MET300, MOR300, T
FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·10796918001228·INSTANT-VIEW Multi-Drugs of Abuse Urine Test
AM...
ADVIA® 120/2120/2120i TESTpoint Retic High Control
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414224442·ADVIA®120/2120/2120i TESTpoint™ Retic High Control
CERALAS D DIODE LASER SYSTEM, MODEL # D50
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC
FDA 510(k)
FDA Class 2
·Cardiovascular
LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·April 3, 2013
FIBERED IDC OCCLUSION SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KRD·March 30, 2011
ONE TOUCH ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·April 25, 2008
GLIDESHEATH
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DYB·November 1, 2022
GLIDESHEATH
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DYB·December 16, 2022
GLIDESHEATH
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DYB·July 30, 2021
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