15 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MTONE EVO (MTONE EVO)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Tontarra Medizintechnik GmbH
FDA UDI
Tontarra Medizintechnik GmbH·04050183353529·PITUITARY Rongeur 30° angled up; 4mm; coated 232mm
Tontarra Medizintechnik GmbH
FDA UDI
Tontarra Medizintechnik GmbH·04050183353536·PITUITARY Rongeur 30° angled up; 6mm; coated 232mm
Tontarra Medizintechnik GmbH
FDA UDI
Tontarra Medizintechnik GmbH·04050183353512·PITUITARY Rongeur 30° angled up; 2mm; coated 232mm
MULTIFIX S KNOTLESS FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INNERVUE DIAGNOSTIC SCOPE SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ASR ACETABULAR CUPS 60
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 9, 2011
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 25, 2008
2.15MM X 22MM SPIRAL ROUTER
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code GFF·July 17, 2013
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code KMW·June 21, 2024
WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
FDA Enforcement
Class II
·Ongoing·Straumann USA LLC·April 30, 2025
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·November 12, 2014
BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019