15 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXX
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033177·Baltic Denture System BDLoad BDLoad ↓ Sw7 PLSEu...
INSTANT-VIEW Methadone Urine Dip-Strip Test
FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·10796918000665·INSTANT-VIEW Methadone Urine Dip-Strip Test
BD CD15 FITC
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code MVU·November 8, 2022
BD CD15 FITC
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code MVU·November 8, 2022
MULTITAK SUTURE SNAP SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ORLON NONABSORABLE SURGICAL SUTURE USP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD CD15 FITC
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code MVU·September 9, 2022
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 1, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·February 28, 2011
ACCU-CHEK ACTIVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·April 23, 2008
BD CD15 FITC
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code MVU·November 4, 2022
BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140 Temse-Belgium The Epilor syringe is used in conjunction with an epidural needle with the purpose of finding the epidural space.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·October 2, 2013
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