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ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Preclean Kit

FDA UDI
MEDIVATORS INC.·40677964007864·Preclean Plus Kit includes Brush, Pentax 4-piec...

Preat Implant Prosthetics

FDA UDI
Preat Corporation·00842092156797·NobelActive™/Conical-compatible RP Digital Analog

Tooth Tone

FDA UDI
ORTHO TECHNOLOGY, INC.·00190730015495·SS Coated Lower 016 10 archwires per pack

General Instrument

FDA UDI
ORTHOPEDIATRICS CORP.·00841132124987·Extractor, Modified

Implant Prosthetics

FDA UDI
Preat Corporation·00842092134771·NobelActive™/Conical-compatible RP Digital Anal...

Implant Prosthetics

FDA UDI
Preat Corporation·00842092134764·NobelActive™/Conical-compatible RP Digital Anal...

3.5MM 90 DEG DFOS PLATE, 4MM OFFSET, 4-HOLE

FDA Adverse Event
Injury ·ORTHOPEDIATRICS, CORP·Product code HRS·February 17, 2020

ORTHOPEDIATRICS 3.5MM, 80 DEGREE, 4-HOLE, 5 DEGREE FLARE, PLATE

FDA Adverse Event
Injury ·ORTHOPEDIATRICS, INC·Product code HRS·June 29, 2018

ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEXALOBE, 26MM

FDA Adverse Event
Injury ·ORTHOPEDIATRICS, INC·Product code HWC·June 22, 2018

ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEXALOBE, 26MM

FDA Adverse Event
Injury ·ORTHOPEDIATRICS, CORP·Product code HWC·June 22, 2018

ORTHOPEDIATRICS LCB CHILD PLATE, 3.5MM, 45MM X 0MM X 4-HOLE

FDA Adverse Event
Injury ·ORTHOPEDIATRICS, INC·Product code HRS·July 24, 2018

ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEX, SIZE 42MM

FDA Adverse Event
Injury ·ORTHOPEDIATRICS, INC·Product code HWC·July 16, 2018

ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEX, SIZE 42MM

FDA Adverse Event
Injury ·ORTHOPEDIATRICS, INC·Product code HWC·July 16, 2018

ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEX, SIZE 42MM

FDA Adverse Event
Injury ·ORTHOPEDIATRICS, INC·Product code HWC·July 16, 2018

ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEX, SIZE 12MM

FDA Adverse Event
Injury ·ORTHOPEDIATRICS, INC·Product code HWC·July 16, 2018

ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEX, 50MM

FDA Adverse Event
Injury ·ORTHOPEDIATRICS, INC·Product code HWC·June 29, 2018

ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEX, 50MM

FDA Adverse Event
Injury ·ORTHOPEDIATRICS, INC·Product code HWC·June 29, 2018

ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEX, SIZE 12MM

FDA Adverse Event
Injury ·ORTHOPEDIATRICS, INC·Product code HWC·July 16, 2018

AVL OPTI R ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry