14 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Plum
FDA UDI
ICU Medical, Inc.·10887787007708·ColorGard LATEX-FREE MIDLENGTH SECONDARY I.V. S...
OneBite™ Facial Axis Recorder
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172012768·Dental facebow measuring device
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809849776·FOR MEN 15-20 MM HG KNEE HIGH CLOSED TOE LARGE-...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450139721·
INJEX 30 NEEDLE FREE INJECTION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
ELECSYS HCG TEST SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INFUSE BONE GRAFT/LT-CAGE
FDA Adverse Event
Injury
·MEDTRONIC·Product code NEK·November 12, 2013
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·April 11, 2013
DON'T KNOW
FDA Adverse Event
Other
·DON'T KNOW·Product code LZS·May 24, 2008
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 12, 2011
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NPT·August 7, 2025
ColorGard, latex-free, Midlength Secondary I.V. Set, convertible pin, 40 inch with Orange striped tubing for use with OMNI-FLOW and PLUM series infusions systems, 15 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made in Costa Rica, list 40521-48.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·November 24, 2009
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