22 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye
FDA 510(k)
FDA Class 2
·General Hospital
GLO MOUTHGUARD - PINK (DZ) *I
FDA UDI
Great Lakes Dental Technologies, Ltd.·D7751910211·GLO MOUTHGUARD - PINK (DZ) *I
THINFLAP SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036129323·
THINFLAP SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00888233007221·
9.1MHZ PENCIL PROBE 841-A
FDA UDI
PARKS MEDICAL ELECTRONICS, INC.·00816787021424·
MODIFICATION TO MEDICOMPASS CONNECT
FDA 510(k)
FDA Class 2
·Cardiovascular
CUBESCAN / BIOCON-700
FDA 510(k)
FDA Class 2
·Radiology
VIDAS® TSH3 ASSAY
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code JLW·October 1, 2019
COCHLEAR OSIA OSI300 IMPLANT
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code PFO·March 8, 2026
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·September 28, 2020
PRECISION®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 21, 2014
UNKNOWN ZIMMER HIP STEM
FDA Adverse Event
Injury
·ZIMMER INC.·Product code JDI·July 29, 2011
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 26, 2013
THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code JEY·May 7, 2020
VOLUMAT MC AGILIA
FDA Adverse Event
Malfunction
·FRESENIUS VIAL S.A.S.·Product code FRN·October 29, 2019
DREAMSTATION AUTO CPAP
FDA Adverse Event
Injury
·RESPIRONICS INC·Product code BZD·May 9, 2022
2.25MM PEDICLE PROBE
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·March 29, 2023
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·March 20, 2025
St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 11, 2018
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022