492 results · 48ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc. Used to administer fluid and drugs intravenously.

FDA Enforcement
Class II ·Terminated·Smiths Medical Asd Inc·June 17, 2015

Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4037, Smiths Medical ASD, Inc, Dublin, Ohio 43016

FDA Recall
Terminated ·Smiths Medical Asd Inc·Product code CBT·November 21, 2007

Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4033, Smiths Medical ASD, Inc, Dublin, Ohio 43016

FDA Recall
Terminated ·Smiths Medical Asd Inc·Product code CBT·November 21, 2007

Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.

FDA Enforcement
Class III ·Terminated·Smiths Medical ASD Inc.·September 26, 2018

CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvented stopper included., 100 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).REF 21-7002-24, STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD Inc.·November 8, 2017

CADD(TM) Yellow Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., REF 21-7100-24, 100mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD Inc.·November 8, 2017

CADD(TM) Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., 50 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps)., REF 21-7001-24, STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD Inc.·November 8, 2017

CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only, STERILE EO, Manufacturer Smiths Medical ASD, Inc.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD Inc.·September 6, 2017

Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD Inc.·January 10, 2018

Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD Inc.·January 10, 2018

Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparin, models 4037NP-1, 4039-1, 4039EG-1, 4044EG-1, 4044P-1, 4057NP-1, 4067NP-1, 4077EG-1, 4077NP-1, 4084P-1, G1193, G1374, G1585, G1589, G1598, G1621, and G1806. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD Inc.·February 27, 2019

CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY

FDA Recall
Terminated ·Smiths Medical ASD Inc.·Product code FRN·November 22, 2017

CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD Inc.·January 10, 2018

Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, models 4589P-1, 4591EG-1, 4591P-1, 4599P-1, 4611LH, 4611P-1, 4620EG-1, 4620P-1, 4640LH, 4640P-1, 4649P-1, 4660EG-1, 4660P-1, 4699LH, 4699P-1, G1325, G1412, G1481, G1509, G1548, G1581, G1586, G1602, G1627, G1632, G1634, G1671, G1675, G1716, G1724, G1773, and G1807. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD Inc.·February 27, 2019

CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only, STERILE EO, Manufacturer Smiths Medical ASD, Inc.

FDA Recall
Terminated ·Smiths Medical ASD Inc.·Product code FRN·June 5, 2017

Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.

FDA Recall
Terminated ·Smiths Medical ASD Inc.·Product code JKA·July 13, 2018

Blue Line Ultra Tracheostomy Tube 8.00mm Inner Cannula REF 100/858/080

FDA Recall
Terminated ·Smiths Medical ASD, Inc.·Product code BTO·March 7, 2006

Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc. Used to administer fluid and drugs intravenously.

FDA Recall
Terminated ·Smiths Medical Asd Inc·Product code FPA·May 4, 2015

CADD(TM) Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., 50 mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps)., REF 21-7001-24, STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).

FDA Recall
Terminated ·Smiths Medical ASD Inc.·Product code FRN·September 25, 2017

CADD(TM) Yellow Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included., REF 21-7100-24, 100mL, For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).STERILE EO, Smiths Medical ASD, Inc. For use with CADD(R) pumps (except CADD-Micro(TM), CADD-MS(R) 3 and CADD-TPN(R) pumps).

FDA Recall
Terminated ·Smiths Medical ASD Inc.·Product code FRN·September 25, 2017