107 results
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27ms
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Sources: EU EUDAMED, US FDA
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EPIX Therapeutics DiamondTemp Bidrectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB400L, SterileEO, UDI: 00812499030303
FDA Recall
Open, Classified
·EPIX THERAPEUTICS, INC·Product code OAE·February 22, 2021
EPIX Therapeutics DiamondTemp Bidrectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:CEDTB300S, SterileEO, UDI: 00812499030358
FDA Recall
Open, Classified
·EPIX THERAPEUTICS, INC·Product code OAE·February 22, 2021
EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF CEDT100S, SterileEO, UDI 00812499030198
FDA Recall
Open, Classified
·EPIX THERAPEUTICS, INC·Product code OAE·February 22, 2021
EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Large Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT200L, SterileEO, Rx Only, UDI: 00812499030013
FDA Recall
Open, Classified
·EPIX THERAPEUTICS, INC·Product code OAE·February 22, 2021
EPIX Therapeutics DiamondTemp Unidirectional Ablation Catheter, Small Curve, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF:DT100S,SterileEO, Rx Only, UDI: 00812499030006
FDA Recall
Open, Classified
·EPIX THERAPEUTICS, INC·Product code OAE·February 22, 2021
EPIX Therapeutics DiamondTemp Unidirectional Large Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF: CEDT200L, Sterile EO, UDI: 00812499030259
FDA Recall
Open, Classified
·EPIX THERAPEUTICS, INC·Product code OAE·February 22, 2021
3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-222A. The NeoCoil 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation. To be used in conjunction with Toshiba 3T Magnetic Resonance Scanners with ODU connectors to produce diagnostic images of the upper and lower extremities, chest, abdomen, pelvis, head, neck and spine that can be interpreted by a trained physician.
FDA Recall
Terminated
·NeoCoil, LLC·Product code MOS·June 17, 2016
Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code KFM·December 3, 2019
Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370 Cardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 5. 8888571299 Cardinal Health Aqua-Seal CDU, Wet Suction 6. 8888571406 Cardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 7. 8888571315 Cardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector 8. 8884713100 Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL 9. 1814713105 OUSOnly - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) 10. 1180571570 OUSOnly - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL 11. 8884713308 Cardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL 12. 8884713900 Cardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL
FDA Recall
Open, Classified
·Cardinal Health 200, LLC·Product code GCX·December 26, 2025
Datex-Ohmeda S/5 Anesthesia Delivery Unit (ADU)
FDA Recall
Terminated
·GE Healthcare·Product code BSZ·November 16, 2005
GE Datex-Ohmeda ADU Carestation Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients.
FDA Recall
Terminated
·GE Healthcare·Product code BSZ·October 30, 2008
Microstream SCP H PLUS O2 ADU/INT 100UN Part Number: 010625
FDA Recall
Terminated
·Oridion Medical·Product code cck·May 26, 2010
Microstream SMART CAPNOLINE PLUS O2 LONG ADU/INT 25UN Part Number: 009826
FDA Recall
Terminated
·Oridion Medical·Product code cck·May 26, 2010
Microstream SMART CAPNOLINE H PLUS O2 ADU/INT 25UN Part Number: 010433
FDA Recall
Terminated
·Oridion Medical·Product code cck·May 26, 2010
Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
FDA Recall
Open, Classified
·Abbott Molecular, Inc.·Product code OOI·November 11, 2022
Microstream FILTERLINE SET ADU/PED 25UN Part Number: XS04620-01 Oridion XS04661 Physio Control
FDA Recall
Terminated
·Oridion Medical·Product code cck·May 26, 2010
Microstream SMART CAPNOLINE PLUS ADU/INT 25UN Part Number: 009818 Oridion 3012176-011 Physio Control
FDA Recall
Terminated
·Oridion Medical·Product code cck·May 26, 2010
Microstream SMART CAPNOLINE PLUS O2 ADU/INT 25UN Part Number: 009822 Oridion 3012176-012 Physio Control
FDA Recall
Terminated
·Oridion Medical·Product code cck·May 26, 2010
Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage. Product Usage: The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implanatations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.
FDA Recall
Terminated
·Philips Electronics North America Corporation·Product code OWB·January 4, 2018
Datex-Ohmeda AS/3 Anesthesia Delivery Unit An Anesthesia Gas Machine for composition of anesthetic breathing gas and manual or mechanical ventilation for patients undergoing anesthesia. Indicated for all persons that require inhalation anesthesia.
FDA Recall
Terminated
·GE Healthcare·Product code BSZ·October 30, 2008