105 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HERA W9, HERA W10 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116022540·600 micron core/1040 micron OD Luer Lock Diode ...
Dornier MedTech
FDA UDI
Dornier MedTech GmbH·04049958002144·600 Micron Disposable Diode Laser Lightguide, 2...
NA
FDA UDI
Synthes GmbH·10886982151605·2.4MM CANNULATED SCREW LONG THREAD 24MM
Diamond Orthopedic, LLC
FDA UDI
DIAMOND ORTHOPEDIC, LLC·B551DMD2118240·2.4mm, Cannulated Screw, Long Thd., 24mm
Medical Facets NC
FDA UDI
MEDICAL FACETS NC LLC·M933MDF2118240·2.4mm Cannulated Screw, Long Thread, 24mm
AGILENT M2636B TELEMON B MONITOR (TELEMON B)
FDA 510(k)
FDA Class 2
·Cardiovascular
FLAT PANEL DETECTOR
FDA 510(k)
FDA Class 2
·Radiology
CAIMAN DISP. INSTR. NON ARTICUL. D:5/360MM
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code GEI·December 12, 2014
GÜNTHER TULIP VENA CAVA FILTER JUGULAR APPROACH
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·July 12, 2022
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·October 29, 2014
MCA MED APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDO·August 15, 2011
LINOX SMART SD 60/16
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVY·July 8, 2013
GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022
GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022
GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022
injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25 gauge
FDA Enforcement
Class II
·Ongoing·Labories Medical Technologies·May 10, 2023
GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·September 25, 2023
GUNTHER TULIP NAVALIGN FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022
GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·May 19, 2022