17 results · 21ms · Sources: EU EUDAMED, US FDA

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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