11 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PREMIER IMPLANT CEMENT, MODEL 3001450
FDA 510(k)
FDA Class 2
·Dental
Young
FDA UDI
YOUNG DENTAL MANUFACTURING I, LLC·00302730333091·Pink Coral Prophy Paste, with Fluoride, Fine Gr...
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033309·Baltic Denture System BDLoad BDLoad ↓ Mn7 PLSEu...
GLUCOPRO EVO INFUSION PUMP
FDA 510(k)
FDA Class 2
·General Hospital
DERMAGRIP POWDER FREE GREEN POLYMER COATED EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE
FDA 510(k)
FDA Class 1
·General Hospital
SECURE 3 MED/SURG BEDOBS 01/13
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 3, 2013
VICKS
FDA Adverse Event
Other
·KAZ INC·Product code KFZ·March 17, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·March 3, 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
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021