149 results
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17ms
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Sources: EU EUDAMED, US FDA
X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541
FDA Enforcement
Class II
·Terminated·Gambro Renal Products, Incorporated·August 20, 2014
MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·January 31, 2018
PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch
FDA Enforcement
Class II
·Terminated·Gambro Renal Products, Incorporated·August 20, 2014
Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
FDA Enforcement
Class II
·Terminated·AURIS HEALTH INC·November 27, 2019
Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.
FDA Enforcement
Class II
·Terminated·Mar Cor Purification·March 19, 2014
LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, product# 101445 model: MA-03, and disposables (product#, model) [#101447, KP-05 Sulflux Plasma Separator], [#101473, HDE KP-05 Sulflux Plasma Separator], [#101785, LA-15 (AU) LDL Adsorption Column (Luer Lock Type)], [#101786, NK-M3R(UL) Tubing (Luer Lock Type)], [#101788, HDE LA-15(AU) LDL Adsorption Column (Luer Lock Type)], [#101789, HDE NK-M3R(UL) Tubing (Luer Lock Type)]. Associated labeling: 1) Instructions for Use (6): IFU LIPOSORBER LA-15 LDL Adsorption Columns FH, IFU SULFLUX KP-05 PLASMA SE-PARATOR FH, IFU TUBING SYSTEM FOR PLASMAPHERESIS NK-M3R(UL) FH, IFU LIPOSORBER LA-15 LDL Adsorption Columns FSGS, IFU SULFLUX KP-05 PLASMA SE-PARATOR FSGS, IFU TUBING SYSTEM FOR PLASMAPHERESIS NK-M3R(UL) FSGS, 2) Operators Manuals for the following (2): LIPOSORBER LA-15 SYSTEM OPERATOR's MANUAL FH, LIPOSORBER LA-15 SYSTEM OPERATOR's MANUAL FSGS 3) Patients Guide (1): A PATIENT GUIDE TO THE LIPOSORBER LA-15 SYSTEM FSGS
FDA Enforcement
Class II
·Terminated·Kaneka America Corp·April 20, 2022
REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE
FDA Enforcement
Class II
·Terminated·Enztec Limited·February 3, 2021
Target Detachable Coils: TARGET 360 NANO 1.5 MM X 2 CM MODEL Number: M0035421520 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
FDA Enforcement
Class II
·Terminated·Stryker Neurovascular·July 20, 2016
Target Detachable Coils: TARGET 360 NANO 1.5 MM X 4 CM MODEL Number:M0035421540 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
FDA Enforcement
Class II
·Terminated·Stryker Neurovascular·July 20, 2016
Target Detachable Coils: TARGET 360 NANO 1 MM X 2 CM MODEL Number: M0035421020 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
FDA Enforcement
Class II
·Terminated·Stryker Neurovascular·July 20, 2016
Target Detachable Coils: TARGET HELICAL NANO 1 MM X 2 CM MODEL Number:M0035431020 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
FDA Enforcement
Class II
·Terminated·Stryker Neurovascular·July 20, 2016
Target Detachable Coils: TARGET 360 NANO 1.5 MM X 3 CM MODEL Number: M0035421530 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
FDA Enforcement
Class II
·Terminated·Stryker Neurovascular·July 20, 2016
Target Detachable Coils: TARGET 360 NANO 3MM X 6CM MODEL Number:M0035443060 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
FDA Enforcement
Class II
·Terminated·Stryker Neurovascular·July 20, 2016
Target Detachable Coils: TARGET 360 NANO 2MM X 3CM MODEL Number:M0035442030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
FDA Enforcement
Class II
·Terminated·Stryker Neurovascular·July 20, 2016
LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip
FDA Enforcement
Class II
·Terminated·LumiraDx·July 27, 2022
Target Detachable Coils: TARGET 360 NANO 2.5 MM X 4CM MODEL Number:M0035442540 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
FDA Enforcement
Class II
·Terminated·Stryker Neurovascular·July 20, 2016
Target Detachable Coils: TARGET HELICAL NANO 1 MM X 3 CM MODEL Number:M0035431030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
FDA Enforcement
Class II
·Terminated·Stryker Neurovascular·July 20, 2016
Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 3 CM MODEL Number:M0035431530 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
FDA Enforcement
Class II
·Terminated·Stryker Neurovascular·July 20, 2016
Target Detachable Coils: TARGET HELICAL NANO 1 MM X 1 CM MODEL Number:M0035431010 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
FDA Enforcement
Class II
·Terminated·Stryker Neurovascular·July 20, 2016
VITEK¿ 2 Gram-Negative identification card (GN), IVD, REF 21341, 20 cards per carton.
FDA Enforcement
Class II
·Terminated·Biomerieux Inc·June 21, 2017