November

DatumŠtevilka zadeveProizvajalecMedicinski pripomoček
02.11.2023P301-109/2023Medtronic Inc..ZDACobalt XT, Cobalt, Crome Implantable Cardioverter/Defibrillator Systems
– Viva™ and Brava™ Cardiac Resynchronization Therapy-Defibrillation (CRTD) Devices
– Evera™ Implantable Cardioverter-Defibrillator (ICD) Devices
– Evera MRI SureScan Implantable Cardioverter Defibrillator (ICD) Devices
– Visia AF™ and Visia AF MRI™ SureScan™ Single Chamber (VR) Implantable Cardioverter-Defibrillator (ICD) Devices
– Primo MRI™ and Mirro MRI™ SureScan™ Implantable Cardioverter-Defibrillator (ICD) Devices
– Claria MRI™, Amplia MRI™, Compia MRI™ CRT-D implantable cardioverter defibrillator with cardiac resynchronization therapy and SureScan Technology
Posodobljeno varnostno obvestilo
02.11.2023P301-233/2023BioFire Diagnostics, LLC, ZDABCID2 Panel
06.11.2023P301-234/2023Ambu A/S, DKAmbu® aView 2 Advance
07.11.2023P301-197/2023Olympus Medical Systems
Corporation, JP		High Flow Insufflation Unit
Posodobljeno obvestilo, Priloga
07.11.2023P301-235/2023Drägerwerk AG & Co. KGaA, DEOxylog 3000 plus
07.11.2023P301-236/2023Drägerwerk AG & Co. KGaA, DEBabyroo TN300 Radiant Warmer
08.11.2023P301-237/2023Olympus Medical Systems
Corporation, JP
EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500 ; CV-1500 / N6011250
08.11.2023P301-238/2023EPOCAL Inc., CAEpoc NXS Host
08.11.2023P301-239/2023EPOCAL Inc., CAEpoc NXS Host
10.11.2023P301-240/2023SCHILLER MEDICAL, FRDEFIGARD Touch-7
10.11.2023P301-241/2023GE Hualun Medical Systems Co. Ltd, CNDefinium Tempo – Definium Tempo Pro
10.11.2023P301-242/2023Medtronic MiniMed, ZDAGuardian™ 4 Sensor
Obvestilo 1, Obvestilo 2, Obvestilo 3
13.11.2023P301-243/2023Siemens Healthcare
Diagnostics Inc., ZDA		RAPIDPoint 500 Systems Measurement Cartridge
13.11.2023P301-244/2023Maquet Cardiopulmonary
GmbH, DE		Cardiohelp-i
14.11.2023P301-245/2023Actim Oy, FIActim Partus
14.11.2023P301-246/2023Actim Oy, FIActim PROM
14.11.2023P301-247/2023nal von minden GmbH, DENADAL® Strep A Test
15.11.2023P301-248/2023BioFire Diagnosticss, LLC, ZDABIOFIRE FILMARRAY TORCH
15.11.2023P301-249/2023ResMed Pty Ltd, AUAirFit N10/N20/F20/F20NV/F30/F30i-AirTouch N20/F20
Obvestilo 1, Obvestilo 2, Obvestilo 3
15.11.2023P301-250/2023Covidien llc, ZDAKangaroo Enteral Feeding Pump Sets
Obvestilo 1, Obvestilo 2
15.11.2023P301-251/2023Becton, Dickinson and
Company, ZDA		BD BACTEC™ MicroMGIT Calibration Vial
15.11.2023P301-253/2023Olympus Winter & Ibe GmbH, DEVideo telescope “ENDOEYE HD II”, 10 mm, 0° and 30°
16.11.2023P301-252/2023QuidelOrtho (Ortho Clinical
Diagnostics Inc), ZDA		VITROS Chemistry Products CKMB
21.11.2023P301-224/2023Philips Medical Systems Nederland B.V., NLBrilliance CT Big Bore; Philips CT Big Bore
Posodobljeno obvestilo
21.11.2023P301-254/2023Olympus Medical Systems
Corporation, JP		OLYMPUS TJF-Q190V/Q290V/Q170V DUODENOSCOPE
21.11.2023P301-255/2023Covidien llc, ZDAValleylab™ FT10 FT Series Energy Platform
22.11.2023P301-169/2023Philips Medical Systems Nederland BV, NLPhilips Allura Xper, Azurion and MultiDiagnost -E
Posodobljeno obvestilo 1, Posodobljeno obvestilo 2
22.11.2023P301-256/2023Abbott Diagnostics
Scarborough, Inc., ZDA		ID NOW Instrument
22.11.2023P301-257/2023Bard Peripheral Vascular, Inc., ZDABard® Mission® Disposable Core Biopsy Kit
22.11.2023P301-258/2023Medtronic, Inc., ZDASynchroMed™ II
23.11.2023P301-252/2022Roche Molecular Systems,
 Inc.,USA		cobas® SARS-CoV-2 & Influenza A/B (catalogue number: 09233474190) for use on the cobas®  6800/8800  Systems
cobas® SARS-CoV-2 & Influenza A/B (catalogue number: 09446125190) for use on the cobas® 5800/6800/8800 Systems
cobas® Influenza A/B & RSV UC (catalogue number: 09233962190) for use  on the cobas® 6800/8800  Systems
Posodobljeno obvestilo
23.11.2023P301-259/2023SHIMADZU Corporation, JPCLAM-2030 CL/CLAM-2040 CL ; / S241-18700-55
24.11.2023P301-261/2023Exactech, Inc., ZDA320-36-03 – 145-DEG PE 36MM HUM LINER  +2.5
24.11.2023P301-262/2023Ecolab Deutschland GmbH, DEIncidin OxyWipe S; Incidin OxyFoam S
27.11.2023P301-223/2023Illumina, Inc., ZDANextSeq 550Dx Instrument / MiSeq Dx Instrument
Posodobljeno obvestilo
28.11.2023P301-264/2023Gyrus ACMI, Inc.
(Olympus Surgical
Technologies America), ZDA		EZDilate Fixed Wire (Guided) Balloon
29.11.2023301-197/2021Caesarea Medical Electronics Limited, ILBodyGuard™ Infusion Pumps Systems (LVP)
Posodobljeno obvestilo
29.11.2023P301-260/2023GeneProof a.s., CZGeneProof Enterovirus PCR Kit
30.11.2023P301-265/2023Nova Biomedical, ZDA
PRIME Plus, PRIME Plus Vet ;
/ 57400, 57808, 59508,
63368 and 63369
30.11.2023P301-266/2023KARL STORZ SE & Co. KG, DE
615000 – BEYER Antrum Punch
615010 – Antrum Punch, 65°, 11 cm
615025 – Sphenoid Punch, 30°, 11 cm
648500 – Sphenoid Punch, 3.2 x 4 mm
648523 – Sphenoid Punch, 30°, 1.6 x 2 mm
662797 – Galea Spring Hook, 31 cm
723014 – Uvula Retractor
723400 – Optical Biopsy and Grasping Forceps
11003MB – Grasping Forceps, flexible, 1 mm
11540OS – Optical Scissor
26161UH – Working Insert, with steering lever
30.11.2023P301-267/2023Cardiac Pacemaker Inc, ZDAModel 3120 ZOOM PRM with Model 2892 Software
30.11.2023P301-268/2023Philips Medical Systems
Nederland BV,NL		Philips Azurion, Philips Allura
30.11.2023P301-269/2023Olympus Medical Systems
Corporation, JP		OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE
30.11.2023P301-270/2023The Insides Company Limited,
New Zealand		The Insides System

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