19 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MAC-LINE CO2 NASAL CANNULA SAMPLE LINE
FDA 510(k)
FDA Class 2
·Anesthesiology
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890123910·Zirlux Shading Liquid - Dentin, C3, 100ml
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04047872673136·LEVAMED STABILI-TRI ANK SUP BLU L I
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033392935·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033392928·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033392904·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033392881·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033392911·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033392898·
NITRILE PATIENT EXAMINATION GLOVE, POWDERED, NON-STERILE, (MULTIPLE COLORS)
FDA 510(k)
FDA Class 1
·General Hospital
ATLAS MULTI-PURPOSE DSA SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DESARA
FDA Adverse Event
Injury
·CALDERA MEDICAL, INC.·Product code PAH·March 7, 2013
75MM SELECTABLE NEW TLC
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·March 9, 2011
LEGEND XT 4 CH COMBO
FDA Adverse Event
Other
·CHATTANOOGA GROUP·Product code IPF·March 7, 2008
INSET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·December 22, 2025
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
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022
Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·October 2, 2019
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018