58 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108696394·Dynamic Dental Implant Ø6mm L11.5mm
LEONE SPA
FDA UDI
LEONE SPA·08033707018124·CALIBRA 1ST MOLAR BANDS n.LL 25
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889981168643·CORTICAL SHANK, Cannulated, 7.0 X 25
MSI
FDA UDI
Modern Surgical Instruments LLC·00810130203833·MF-Swivel Adaptor
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889987168647·CORTICAL SHANK, Cannulated, 7.0 X 25
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197516051·Deaver Retractor
25x265...
Horico Diamonds
FDA UDI
Hopf, Ringleb & Co. GmbH & Cie.·EHORFG1700252·Rotary Diamond Instrument
LINK Instruments - Chisel, bone curette, raspatory, rongeur
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575120673·Orthopaedic prosthesis instrument, reusable - G...
Horico
FDA UDI
Hopf, Ringleb & Co. GmbH & Cie.·EHORFG1700255·Rotary Diamond Instrument
SURGIMESH XB - SKIRTED
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
C.T.M. MOBILITY SCOOTER, MODEL HS-310
FDA 510(k)
FDA Class 2
·Physical Medicine
SECTRA MICRODOSE MAMMOGRAPHY
FDA 510(k)
FDA Class 2
·Radiology
Widex
FDA UDI
Widex A/S·05706069897821·WIDEX EVOKE E-XP (Light beige ) 30, Telecoil, R...
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 2
·Aptima HBV Quant Assay
ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·November 11, 2020
MILLENNIUM VENTILATOR
FDA Adverse Event
Malfunction
·SECHRIST INDUSTRIES, INC.·Product code CBK·July 22, 2016
STELLARIS ELITE VISION ENHANCEMENT SYSTEM
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code HQC·March 1, 2022
MILLENNIUM VENTILATOR
FDA Adverse Event
Malfunction
·SECHRIST INDUSTRIES, INC.·Product code CBK·December 17, 2015
25 GA POSTERIOR WIDE-FIELD ELITE PACK
FDA Adverse Event
Malfunction
·BAUSCH + LOMB, INC·Product code HQC·December 6, 2019
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 2
·Aptima HBV Quant Assay