22 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICAL
FDA 510(k)
FDA Class 2
·Cardiovascular
CRYOPEN CRYOSURGICAL SYSTEM, K102214
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837010775·
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837027261·PLATEAU Interbody, Curved, Bulleted, 11mm 27mm ...
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837010683·
ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR
FDA 510(k)
FDA Class 1
·General Hospital
WARTNER WART REMOVAL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
T-Plus PEEK IBF System
FDA UDI
Pioneer Surgical Technology, Inc.·00846468088484·INTERBODY FUSION DEVICE
T-PLUS™* PEEK VBR/IBF SYSTEM
FDA UDI
Pioneer Surgical Technology, Inc.·00846468032593·T-Plus, 10X27X14
HAHN TAPERED IMPLANT 3.5 X 11.5
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·June 16, 2022
LTXFR CYSTOSCOPY IRR
FDA Adverse Event
Malfunction
·ICU MEDICAL COSTA RICA LTD.·Product code GBX·March 25, 2020
Fortilink Cages with TiPlus Technology
FDA UDI
Baat Medical Products B.V.·08720246786156·
Fortilink Cages with TiPlus Technology
FDA UDI
Baat Medical Products B.V.·08720246786231·
Fortilink Cages with TiPlus Technology
FDA UDI
Baat Medical Products B.V.·08720246786064·
XIA 3 TITANIUM BLOCKER
FDA Adverse Event
Injury
·STRYKER SPINE-SWITZERLAND·Product code MNH·May 9, 2013
FENESTRATED BIPOLAR FORCEPSINSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·September 19, 2014
9400
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 23, 2011
BD PHASEAL¿ SPIKE CONNECTOR (C180J)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·November 23, 2021
HAHN TAPERED IMPLANT 3.5 X 11.5
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·November 2, 2021
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog Number 2602Z Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).
FDA Enforcement
Class II
·Terminated·ConMed Corporation·April 4, 2018