22 results · 18ms · Sources: EU EUDAMED, US FDA

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LIFE O2

FDA 510(k)
FDA Class 2 ·Anesthesiology

DeRoyal

FDA UDI
DEROYAL INDUSTRIES, INC.·00749756349864·CLOSING BUNDLE PACK

DeRoyal

FDA UDI
DEROYAL INDUSTRIES, INC.·00749756019125·WRIST AND FOREARM

Gen. Acces/ Instr. Tip Guard

FDA UDI
KATENA PRODUCTS, INC.·00841668112267·SURG-I-BAND ORANGE

Novo Surgical

FDA UDI
NOVO SURGICAL, INC.·00842331120534·endoscopic clip applier, 5 mm diameter, rotatab...

Grasping forceps

FDA UDI
SOPRO-COMEG GmbH·04059082022147·

Reicodent

FDA UDI
devemed GmbH·04061644050321·BASIC Wash Tray (275x87x35mm) with top cover ...

EXPLOR RADIAL HEAD PLATING SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

BAYER ADVIA IMS SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·November 30, 2010

EASYTRAK 2

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code OJX·January 11, 2013

V60 VENTILATOR

FDA Adverse Event
Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code MNT·July 2, 2014

Achieva 1.5T Conversion

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·November 29, 2023

Full Range C-reactive Protein (FR-CRP) Assay Kit (Nephelometry)

Basic UDI-DI
EU IVDD · Eu Ivd General ·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device

Erythrocyte Osmotic Fragility Test (EFT) Kit (Nephelometry)

Basic UDI-DI
EU IVDD · Eu Ivd General ·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device

Procalcitonin (PCT) Assay Kit (Nephelometry)

Basic UDI-DI
EU IVDD · Eu Ivd General ·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device

Hypersensitive C-reactive Protein (hs-CRP) Assay Kit (Nephelometry)

Basic UDI-DI
EU IVDD · Eu Ivd General ·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device

C-reactive Protein (CRP) Assay Kit (Nephelometry)

Basic UDI-DI
EU IVDD · Eu Ivd General ·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device

C-reactive Protein (CRP) Control

Basic UDI-DI
EU IVDD · Eu Ivd General ·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device

C-reactive Protein (CRP) Calibrator

Basic UDI-DI
EU IVDD · Eu Ivd General ·SHENZHEN REETOO BIOTECHNOLOGY CO., LTD·1 device