12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INION CPS BABY 1.5 BIOABSORBABLE SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033194·Baltic Denture System BDLoad BDLoad Mn6 PLSEbi...
BENCO
FDA UDI
BENCO DENTAL SUPPLY CO.·00366975015419·Titanium #5.5, Endodontic, Parallel Posts, Pkg ...
PALATAL BAR
FDA UDI
Ortho Organizers, Inc.·00190707055820·Beta Titanium Reverse Loop Palatal Bar 45mm
STACKHOUSE LENS HOOD, MODEL SA-700/FS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UNIMARK HCG COMBO PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ABRAMS MULTIDENSITY POLYURETHAN FOAM WOUND DRESSING SYSTEM
FDA Adverse Event
Other
·DR LEN'S MEDICAL PRODUCTS·Product code FRO·October 11, 2005
DEPUY ASR XL FEM IMP SIZE 51
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 3, 2013
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·February 28, 2011
UNK
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code HSH·April 21, 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