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

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RELAXU-1

FDA 510(k)
FDA Class 1 ·Physical Medicine

SpiritMB

FDA UDI
ORMCO CORPORATION·00889989007398·ID U - Twin - Lower-Left Cuspid - Purple

ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

FLOGARD

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 8, 2013

ILLUMENA-SYR-W/HF-150ML BX50

FDA Adverse Event
Malfunction ·COVIDIEN·Product code DXT·December 14, 2010

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 22, 2014

Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

FDA Enforcement
Class II ·Terminated·Stryker Sustainability Solutions·July 1, 2015

N-terminal pro-B-type Natriuretic Peptide &Cardiac Troponin I Combo Test Kit (Fluorescence Immunochromatographic Assay)

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

Beta 2 microglobulin (β2-MG) Test Kit (Fluorescence Immunochromatographic Assay)

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

Serum Amyloid A (SAA) & Full C-reactive protein (CRP) Combo Test Kit (Fluorescence Immunochromatographic Assay)

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

Procalcitonin (PCT) & Full C-reactive protein (CRP) Combo Test Kit (Fluorescence Immunochromatographic Assay)

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

Thyroid Stimulating Hormone(TSH) Test Kit (Fluorescence Immunochromatographic Assay)

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

Total Thyroxine(T4) Test Kit (Fluorescence Immunochromatographic Assay)

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

Total Triiodothyronine(T3) Test Kit (Fluorescence Immunochromatographic Assay)

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

Myoglobin (Myo) Test Kit (Fluorescence Immunochromatographic Assay)

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

Cardiac Troponin I (cTnI) Test Kit (Fluorescence Immunochromatographic Assay)

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

Full C-reactive protein (CRP) Test Kit (Fluorescence Immunochromatographic Assay)

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

Creatine kinase Isoenzyme MB(CK-MB) Test Kit (Fluorescence Immunochromatographic Assay)

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

Serum Amyloid A (SAA) Test Kit (Fluorescence Immunochromatographic Assay)

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