18 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MODIFICATION TO ELECSYS FSH II CALSET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CERASMART®
FDA UDI
Gc America Inc.·D0470123991·CERASMART 270 12 A3.5 HT CEREC 5p
CERASMART®
FDA UDI
Gc America Inc.·14548161320061·CERASMART™ 270 12 Cerec A3.5 HT 5p Block
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033397930·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033397879·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033397923·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033397947·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033397893·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033397916·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033397886·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033397909·
MODIFICATION TO CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PELORIS RAPID TISSUE PROCESSOR
FDA Adverse Event
Injury
·LEICA BIOSYSTEMS MELBOURNE·Product code IEO·March 14, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·March 9, 2011
BIODESIGN 4-LAYER TISSUE GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH, INC.·Product code FTM·July 31, 2014
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