21 results · 21ms · Sources: EU EUDAMED, US FDA

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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