19 results
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24ms
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Sources: EU EUDAMED, US FDA
MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION
FDA 510(k)
FDA Class 1
·Clinical Chemistry
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304102785·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304102877·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304102792·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304102853·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304102839·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304102815·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304102891·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304102808·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304102860·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304102822·
POWDER-FREE NITRILE EXAM GLOVE, BLUE
FDA 510(k)
FDA Class 1
·General Hospital
LDOB OCCLUSION BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
LAMITRODE TRIPOLE 16
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 12, 2013
NK II CONSTRAINED FEMORAL COMPONENT
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code JDI·February 1, 2011
INTERA ACHIEVA 1.5T NOVA DUAL
FDA Adverse Event
Other
·PHILIPS MEDICAL SYSTEMS·Product code LNH·March 6, 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
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
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012