19 results · 27ms · Sources: EU EUDAMED, 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