15 results
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23ms
·
Sources: EU EUDAMED, US FDA
Folding Mobility Scooter (KD101)
FDA 510(k)
FDA Class 2
·Physical Medicine
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813052693·NITI ROTARY FILE S30/T04 21MM DARBY
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690124405·Modular Offset Stem 15mm x 100mm x 2mm
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197393355·Gruenwald Suction Punch
2mm, 4...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197393348·Gruenwald Suction Punch
2mm, s...
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011252502030·ceraMotion® Me Paste Opaque A2, 3 g / dental ce...
NON-STERILE, POWDER-FREE NITRILE BLUE & WHITE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
Resonic Rapid Acoustic Pulse Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 6, 2026
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code KPE·September 17, 2011
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 15, 2014
TERUMO PERFUSION SYSTEM 8000
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·July 25, 2013
BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·April 3, 2026
Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad¿ Avanta Injection System; Catalog number: AVA 500 MPAT (Part 2 of 2); Affected material numbers: 87629007, 60729458, 86566648;
FDA Enforcement
Class II
·Ongoing·Bayer Medical Care, Inc.·June 10, 2026
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024