20 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND METRICIDE PLUS 30 SOLUTIONS
FDA 510(k)
FDA Class 2
·General Hospital
Zirlux
FDA UDI
HENRY SCHEIN, INC.·00304040056332·Zirlux Multi Anterior A3.5,98.5X12
Silverbolt/Mainframe
FDA UDI
Choice Spine, LP·10885862163608·
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033420874·
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033420881·
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033420911·
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033420898·
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033420867·
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361011569·PedFuse Respond, CNL, 7.0mm x 35mm
JOE FRESH
FDA UDI
FGX INTERNATIONAL INC.·00193033420904·
SLENDERTONE FLEX, MODEL, 512
FDA 510(k)
FDA Class 2
·Physical Medicine
NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA
FDA 510(k)
FDA Class 2
·Orthopedic
TAXUS® LIBERTÉ®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·September 20, 2012
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·February 19, 2013
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·February 1, 2011
ULTRAFLEX COVERED NG ESOPHAGEAL STENT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC IRELAND, LTD.·Product code ESW·February 12, 2008
Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013
Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013
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¿ 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