13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MESA SPINAL SYSTEM (KEYSTONE RODS)
FDA 510(k)
FDA Class 2
·Orthopedic
Smartmix Tips Blue-Green
FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG1109911·Smartmix Tips Blue-Green 10:1. Suitable for: Lu...
NA
FDA UDI
Smith & Nephew, Inc.·03596010036957·JEWETT BONE CHIP PACKER 6.3MM ROUND
MILLENNIUM
FDA UDI
Avalign Technologies, Inc.·00190776353438·Bone Impactor
SEEDNET, MODELS FP6T5, FP5T5, FP5T3
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IMC SURGICAL DRAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 8, 2025
VUE PACS
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD.·Product code LLZ·November 21, 2025
ALIGN R URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BARD SHANNON LIMNITED·Product code FTL·May 8, 2013
MAXI TWIN
FDA Adverse Event
Malfunction
·ARJO HOSPITAL EQUIPMENT AB·Product code FSA·April 29, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 14, 2008
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024