17 results
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21ms
·
Sources: EU EUDAMED, US FDA
ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN
FDA 510(k)
FDA Class 2
·Hematology
Endo Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964150418·Endo Carry-on Procedure Kit Includes Intercept ...
Aligned Medical Solutions
FDA UDI
Aligned Medical Solutions·B09800104550·Shoulder Arthroscopy Pack
DAISY FUENTES
FDA UDI
FGX INTERNATIONAL INC.·00193033151020·
DAISY FUENTES
FDA UDI
FGX INTERNATIONAL INC.·00193033151037·
DAISY FUENTES
FDA UDI
FGX INTERNATIONAL INC.·00193033151006·
BRONCHO CATH ENDOBRONCHIAL TUBE, 37FR
FDA Adverse Event
Malfunction
·MALLINCKRODT MEDICAL·Product code CBI·June 15, 2001
ACCUWELL TSH, MODEL KAW-TSH-960
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GETTIG GUARD
FDA 510(k)
FDA Class 2
·General Hospital
CELSITE ACCESS PORT
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL SAS·Product code LJT·October 23, 2014
PRECISION QID
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·May 11, 2007
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LKK·March 19, 2013
75MM SELECTABLE NEW TLC
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·March 8, 2011
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024
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
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018