25 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Normatec Elite
FDA 510(k)
FDA Class 2
·Physical Medicine
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776182038·Bruns Curette hollow hdl str oval Size
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776415792·Bruns Curette 10" Hollow Hdl Str Oval Size #0
MaXcess
FDA UDI
Nuvasive, Inc.·00887517196675·MaXcess 4 Bedrail Clamp
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780187349·Integra® Jarit® Bruns Oval Cup Curette, 9", Str...
Auxiliary Combo Box- Original Sidewinder
FDA UDI
TP ORTHODONTICS INC·00192029028384·CW Oriented
NA
FDA UDI
aap Implantate AG·04042409097256·Screwdriver cannulated CS 5.8, hexagonal, ø3.5
MAYO CLINIC BC-10 3.0T
FDA 510(k)
FDA Class 2
·Radiology
CANDELA GENTLEMAX FAMILY OF LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TENDRIL SDX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011
COLLEAGUE 3 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 24, 2008
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·July 18, 2013
UNKNOWN
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NDN·April 13, 2026
UNKNOWN
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NDN·April 13, 2026
G7 OSSEOTI 3 HOLE SHELL 50MM D
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LPH·September 13, 2022
G7 BALL HEX DRVR FOR INSR HNDL
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code PBI·September 13, 2022
G7 STR MODULAR SHELL INSERTER
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code PBI·September 13, 2022
MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S5 RM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·March 8, 2024
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
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