18 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RODIN Palette Naturalizing Kit
FDA 510(k)
FDA Class 2
·Dental
CoRoent
FDA UDI
Nuvasive, Inc.·00887517630056·CoRoent Ant TLIF Ti, 12x13x36mm 15°
Wrist Lacer II
FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357233656·
ET Catheter
FDA UDI
KITAZATO CORPORATION·04580745044287·ET Catheter
ATRAMAT
FDA UDI
Internacional Farmacéutica, S.A. de C.V.·07500142080531·ATRAMAT SILK SURGICAL SUTURE BLACK USP 3-0 EP 2...
OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LEFORTE SYSTEM BONE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
5.5 EXP VERSE FEN SCR 6.0X50
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÃ RL CH·Product code PML·June 24, 2021
GLIDEWELL HT IMPLANT Ø4.3 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 22, 2025
GLIDEWELL HT IMPLANT Ø4.3 X 10 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 11, 2025
VERITY ADX XL
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2008
Y-TYPE EXTENSION SET WITH OPTION LOK
FDA Adverse Event
Malfunction
·HOSPIRA·Product code FPA·August 15, 2011
OT VERIO PRO PLUS METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 12, 2013
IMP,TSV,4.1MM,SBM,11.5
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·July 24, 2021
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·May 28, 2019
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018