22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LIFEPAK® 35 AC Power Adapter (41335-000001)
FDA 510(k)
FDA Class 2
·Cardiovascular
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776412029·Bruns Curette 9" Hex Handle Straight Oval #0
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780183921·Integra® Jarit® Bruns Oval Cup Curette, 9", Sol...
K-Systems
FDA UDI
Coopersurgical, Inc.·00888937025026·R65 Trolley
SYRINGE 60ML LL TIP 1ML 2 OZ IN 1/4 OZ
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·March 6, 2020
AP EXPANDABLE XLIF SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CORRESTORE PATCH SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
TITAN TOUCH
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code FHW·March 17, 2022
SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code GZB·November 10, 2014
TENDRIL ST
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011
INGENIO
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 22, 2013
Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·December 25, 2024
ANN BLUNT TIP SCREW 4X50MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSB·September 17, 2025
ANN BLUNT TIP SCREW 4X50MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSB·September 17, 2025
BLUNT TIP SCREW, ÿ 4X52MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSB·September 17, 2025
ANN BLUNT TIP SCREW 4X52MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSB·September 17, 2025
BLUNT TIP SCREW, ÿ 4X54MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSB·September 17, 2025
ANN PH NAIL RT 10X220MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSB·September 17, 2025
Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A
FDA Recall
Open, Classified
·CooperSurgical, Inc.·Product code PUB·November 15, 2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024