22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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3M Protemp Cement Temporary Dental Cement
FDA 510(k)
FDA Class 2
·Dental
NABATOFF VEIN STRIPPER SET
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896024342·NABATOFF VEIN STRIPPER SET WITH STERILIZING CAS...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197452564·McCulloch Blade
2 teet...
devemed
FDA UDI
devemed GmbH·04061644022670·Filling Instrument, cylindrical
2.5 / 3.5 mm, c...
devemed
FDA UDI
devemed GmbH·04061644024827·Filling Instrument, cylindrical
2.5 / 3.5 mm, c...
Reicodent
FDA UDI
devemed GmbH·04061644050666·Filling Instrument, cylindrical
2.5 / 3.5 mm, c...
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Reicodent
FDA UDI
devemed GmbH·04061644035304·Filling Instrument, cylindrical
2.5 / 3.5 mm, c...
Reicodent
FDA UDI
devemed GmbH·04061644027286·Filling Instrument, cylindrical
2.5 / 3.5 mm, c...
PENUMBRA SMART COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·December 11, 2015
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 14, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 20, 2011
3.5MM CORTEX SCREW SELF-TAPPING
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HWC·September 18, 2008
RED FORCEPS SERRATED JAW-RATCHET 144
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTD·November 26, 2025
INSERT FOR FNS INSERTION HANDLE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code KTT·September 11, 2024
INSERT FOR FNS INSERTION HANDLE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code KTT·April 27, 2023
CAPIOX FX OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·August 4, 2017
CAPIOX FX OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·August 4, 2017
Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with Name/Pack numbers: Ports Cath Pack (1794)/AMS6569, Minor Procedure Pack (20527)/AMS6570B, Breast Biopsy Pack (24771)/AMS6572A, Bone Marrow Pack (11862)/AMS6573, Ultrasound Biopsy Pack -Rx/AMS6828, Ultrasound Biopsy Pack -Rx/AMS6828A, C Access Tray/AMS9954, C Access Tray/AMS9954A, Access Tray A/AMS10234, Access Tray A/AMS10234A, C-Access Tray Chicago/AMS10236, C-Access Tray Chicago/AMS10236A, Access Tray/AMS10238, Access Tray/AMS10238A, Access Tray/AMS10238B, Gray Pack/AMS10247, Gray Pack/AMS10247A, C-Access Tray/AMS10249, C-Access Tray/AMS10249A, C Access Tray/AMS10255, C Access Tray/AMS10255A, Jacksonville Tray/AMS10256, Jacksonville Tray/AMS10256A, Jacksonville Tray/AMS10256B, NVS Access Tray/AMS10257, AZ Access Tray/AMS10271, AZ Access Tray/AMS10271A, Fistulagram/ C-Access Pack/AMS10280, Fistulagram/ C-Access Pack/AMS10280A, Ultrasound Tray w/PDI/AMS10710A, Procedure Tray/AMS10897A, Universal Block Tray-RX/AMS12381, Ultrasound Injection-RX/AMS12382, Pellet Insertion Tray/AMS12735, PICC Insertion Tray - RX/AMS-7192CS-8, Breast Biopsy Tray/DDS1010G, Single Shot Epidural Tray-Rx/DDS1149, PICC Insertion Tray-RX/VYMAXBASIC
FDA Enforcement
Class II
·Ongoing·Windstone Medical Packaging, Inc.·May 25, 2022