13 results
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21ms
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Sources: EU EUDAMED, US FDA
SOHNIKS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033191·Baltic Denture System BDLoad BDLoad ↓ Sm6 PLSEu...
PALATAL BAR
FDA UDI
Ortho Organizers, Inc.·00190707055790·Beta Titanium Reverse Loop Palatal Bar 34mm
MIS IMPLANT SYSTEM DECIVE
FDA 510(k)
FDA Class 2
·Dental
PASS SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HEARTMATE 3 LVAS IMPLANT KIT
FDA Adverse Event
Malfunction
·THORATEC CORPORATION·Product code DSQ·July 27, 2022
UNKNOWN STEM
FDA Adverse Event
Death
·ZIMMER BIOMET, INC.·Product code JDI·December 9, 2021
BD 50ML SYRINGE LUER-LOK¿ TIP
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·June 3, 2022
ADMIRAL XTREME
FDA Adverse Event
Injury
·INVATEC SPA·Product code LIT·April 3, 2013
SECURE 2 MED/SURGBED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·February 28, 2011
ONYX, AVM
FDA Adverse Event
Malfunction
·EV3 NEUROVASCULAR·Product code MFE·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