12 results
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22ms
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Sources: EU EUDAMED, US FDA
ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80
FDA 510(k)
FDA Class 2
·Physical Medicine
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950026579·LATEX TUBING 3/16"X1/8" AMBER 50' RL NS W/L
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032954·Baltic Denture System BDLoad Lw6 PLSEbil2DFl C1...
Lingual Sheaths
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746156939·WELD LINGUAL SHEATH UNIV 036 W/M-D OCCL BAR
NGB-006 Needle-guided Bracket/STEEL
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904018553·
AMEDICA DRUG SCREEN COCAINE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
NOVAMAX LINK GLUCOSE MONITOR
FDA Adverse Event
Malfunction
·NOVA BIOMEDICAL CORPORATION·Product code NBW·April 1, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 29, 2011
ECLIPE
FDA Adverse Event
Other
·I-FLOW CORP.·Product code MEB·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