13 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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SYNTHES ANTERIOR CERVICAL COMPRESSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033844·Baltic Denture System BDLoad BDLoad Mn6 PLSEbi...
DRYVIEW 5950 Laser Imaging System
FDA UDI
CARESTREAM HEALTH, INC.·60889971033840·DRYVIEW 5950 LASER IMAGER, 110V
FINAL VARNISH LC
FDA 510(k)
FDA Class 2
·Dental
VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238
FDA 510(k)
FDA Class 2
·General Hospital
BD SYRINGE 20ML LL TIP CONV PAK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·August 13, 2024
RENU WITH MOISTURELOC MULTIPURPOSE SOLUTION
FDA Adverse Event
Injury
·BAUSCH & LOMB INCORPORATED·Product code LPN·February 18, 2020
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 3, 2013
AFFINITY 3
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code HDD·March 23, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORP.·Product code LZG·April 24, 2008
Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infusion of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions, and other therapeutic fluids.
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·November 30, 2022
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