21 results
·
22ms
·
Sources: EU EUDAMED, US FDA
EmoLED (v. 2-USA)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257125779·30-40 MV FOR MEN CLSC CALF STD TAN II
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257127957·30-40 MV FOR MEN SEL CALF STD TAN II
Delta®
FDA UDI
MEDTRONIC PS MEDICAL, INC.·00613994908087·SHUNT 24013-2 DELTA UNITIZED REG II
Holder, Needle, TC, acc. Mayo-Hegar 20cm
FDA UDI
Geister Medizintechnik GmbH·04057034064375·Holder, Needle, TC, acc. Mayo-Hegar
20cm ...
Delta®
FDA UDI
MEDTRONIC PS MEDICAL, INC.·00643169472822·SHUNT 24013-2 DELTA UNITIZED REG II
NA
FDA UDI
aap Implantate AG·04042409038259·Screwdriver cannulated CS 6.5/7.5, hexagonal, ø5.0
Ashvins
FDA 510(k)
FDA Class 2
·Radiology
BIODENTINE
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 28, 2025
RUSCH GREENSPEC FO HANDLE SMALL
FDA Adverse Event
Malfunction
·TELEFLEX·Product code CCW·October 29, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·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
BELLATEK HYBRID BAR 4 IMPLANTS
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·December 26, 2024
BELLATEK HYBRID BAR 4 IMPLANTS
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·January 6, 2025
BELLATEK¿ HYBRID BAR 5 IMPLANTS
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·February 18, 2025
BELLATEK HYBRID BAR 5 IMPLANTS
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·March 18, 2025
BELLATEK HYBRID BAR 4 IMPLANTS
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·January 6, 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