25 results · 34ms · Sources: EU EUDAMED, US FDA

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VONFLEX HEAVY, VINFLEX LIGHT

FDA 510(k)
FDA Class 2 ·Dental

103164 tCOM+

FDA UDI
SenTec AG·07640121880995·The Sentec patient monitor, model tCOM+, is a p...

NexxZr™ / W-98-30-UT-D300-ML

FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271139825·

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668113981·HYDRO-DISSECT CANNULA 27GA ANGLED 8MM

PMT CORPORATION - STEREOTACTIC

FDA UDI
PMT CORPORATION·00650551143260·VERTEK BUSHING FOR sEEG STYLET, FOR 2.4MM DRILL

UNK HIP FEMORAL HEAD METAL ARTICUL/EZE

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·July 18, 2022

UNK HIP FEMORAL STEM CORAIL

FDA Adverse Event
Injury ·DEPUY IRELAND - 9616671·Product code LPH·July 18, 2022

SURSHIELD SAFETY WINGED BLOOD COLLECTION SET

FDA 510(k)
FDA Class 2 ·General Hospital

TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

CADD CASSETTE 100ML W/FLOWSTOP

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code LHI·July 15, 2021

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·May 9, 2023

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·September 14, 2020

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 9, 2016

DREAMSTATION AUTO CPAP

FDA Adverse Event
Injury ·RESPIRONICS, INC.·Product code BZD·November 21, 2024

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 9, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 19, 2014

SENSIA SR

FDA Adverse Event
Death ·MEDTRONIC MED REL, INC.·Product code NVZ·May 25, 2011

OT ULTRAMINI METER

FDA Adverse Event
Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 19, 2013

Sheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm, Product Code V5-10315 3) Novaplus 8.0 mm, Product Code V5-10316 4) Novaplus 8.5 mm, Product Code V5-10317 Product Usage: Tracheal tube/airway management

FDA Recall
Terminated ·Teleflex Medical·Product code BTR·May 24, 2019

Sheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm, Product Code V5-10315 3) Novaplus 8.0 mm, Product Code V5-10316 4) Novaplus 8.5 mm, Product Code V5-10317 Product Usage: Tracheal tube/airway management

FDA Enforcement
Class I ·Terminated·Teleflex Medical·June 26, 2019