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