125 results
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17ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020;
FDA Recall
Open, Classified
·Abbott Molecular, Inc.·Product code OYU·February 1, 2024
FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code NYU-05500-1
FDA Recall
Terminated
·Arrow International Inc·Product code BSO·January 15, 2020
VNUS Medical U-CLIP Removal Tool, UREM1860, is intended for the removal of U-Clip anastomotic devices.
FDA Recall
Terminated
·Medtronic Cardiac Surgery Technologies·Product code FZP·February 25, 2008
Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215. A blood component separator used for therapeutic plasma exchanges.
FDA Recall
Terminated
·Caridian BCT, Incorporated·Product code LKN·September 21, 2011
McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only.
FDA Recall
Terminated
·Cypress Medical Products LLC·Product code FMF·September 4, 2018
Monoject Insulin Safety Syringe 3/l0mL 29 X 1/2" Product ID: 8881511144 Indications for Use: Injection of U-1 00 insulin
FDA Recall
Terminated
·Covidien LLC·Product code FMF·May 21, 2012
Monoject Insulin Safety Syringe 1/2mL 29 X 1/2" Product ID: 8881511136 Indications for Use: Injection of U-1 00 insulin
FDA Recall
Terminated
·Covidien LLC·Product code FMF·May 21, 2012
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
Monoject Insulin Safety Syringe 1/2mL 30 X 5/16" Product ID: 8881511336 Indications for Use: Injection of U-1 00 insulin
FDA Recall
Terminated
·Covidien LLC·Product code FMF·May 21, 2012
Monoject Insulin Safety Syringe 3/10mL 30 X 5/16" Product ID: 8881511344 Indications for Use: Injection of U-1 00 insulin
FDA Recall
Terminated
·Covidien LLC·Product code FMF·May 21, 2012
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
MONITORING KIT WITH 03ML FLUSH DEVICE FOR NYU MED CTR, Item No. 46094-37 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code DRS·September 27, 2016
Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Reference: 4429-1 Hypodermic Needle-Pro Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code MEG·July 10, 2013
Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in Reference: 4429-5 Hypodermic Needle-Pro Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code MEG·July 10, 2013
Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 0.3ml 29g x 1/2 in Reference: 4429-3 Hypodermic Needle-Pro Fixed Needle Insulin Syringes are sterile, latex free, non-pyrogenic, single use devices intended for injection of U-100 insulin only. The syringe has an integral rotational needle protection sheath.
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code MEG·July 10, 2013