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Medtronic Xomed, Inc.: Lamicel 20PK 5MM INTL

Routine sterilization dose does not meet the required Sterility Assurance Level.

FDANov 13, 2019IN• Medtronic Xomed, Inc.

Linet Spol. S.r.o. Zelevcice 5 Slany Czech Republic: Eleganza 5 (AC powered adjustable bed), Item Numbers: a)...

A component used within the side rail mechanism may malfunction, resulting in the side rail either not locking properly in the upper position or the side rail becoming stuck in the upper position.

FDANov 13, 2019Nationwide• Linet Spol. S.r.o. Zelevcice 5 Slany Czech Republic

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Medtronic Xomed, Inc.: Lamicel 20PK 5MM INTL

Linet Spol. S.r.o. Zelevcice 5 Slany Czech Republic: Eleganza 5 (AC powered adjustable bed), Item Numbers: a)...

Medtronic Xomed, Inc.: Lamicel 20PK 3MM INTL Cervical dilator

Medtronic Xomed, Inc.: Lamicel 10PK 10MM INTL

Villa Sistemi Medicali S.P.A. Via delle Azalee: Juno DRF, Model Number 709020 - Product Usage: General. m...

Villa Sistemi Medicali S.P.A. Via delle Azalee: Apollo EZ, Model Number 9784152036 - Product Usage: The A...

Villa Sistemi Medicali S.P.A. Via delle Azalee: Apollo, Model Numbers 9784100231, 9784120131, 9784130131 ...

Villa Sistemi Medicali S.P.A. Via delle Azalee: Apollo DRF, Model Number 9784220831 - Product Usage: The ...

Medline Industries Inc: Anesthesia Pediatric Circuit 72", Model DYNJAPF6057A

Medtronic Navigation, Inc.: Biopsy Needle FPU Kit, Product # 9731754, UDI: 006431693...

Allergan PLC: XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, ...

Young Dental Manufacturing Co, LLC: Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, ...

Medtronic Navigation, Inc.: Passive Biopsy Needle Kit, UDI: 00643169030121 and 0064...

Beckman Coulter Inc.: iQ200 Series Urine Microscopy Analyzer, Catalog numbers: ...

Beckman Coulter Inc.: iChemVELOCITY, Urine Chemistry System, Catalog numbers: ...

Unknown Manufacturer: EMPOWR Acetabular System, Non-Sterile, Model Numbers 80...

Beckman Coulter Inc.: MicroScan WalkAway-96 plus Instrument REF B1018-284

Beckman Coulter Inc.: DxM 1096 MicroScan WalkAway Instrument REF B1018-496

Beckman Coulter Inc.: MicroScan WalkAway-40 plus Instrument REF B1018-283

Beckman Coulter Inc.: MicroScan WalkAway-40 plus Reconditioned Instrument REF B...