25 results · 30ms · Sources: EU EUDAMED, 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