28 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model
FDA 510(k)
FDA Class 2
·Anesthesiology
Zirlux
FDA UDI
HENRY SCHEIN, INC.·00304040187906·ZIRLUX ML DISC C1 98x22
blueendo
FDA UDI
TROKAMED GmbH·04251303811190·MyTube cap Ø 50 mm, for basic tube 02-00087, re...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694006088·1.0mm Pilot Drill, 6mm Stop, J-Latch
INBONE WRENCH TIB STEM 14
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HXC·February 17, 2026
MAHURKAR TRIPLE LUMEN CATHETER, 12 FR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
INBONE DRIVE TIBIA REAMER
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HTO·February 17, 2026
4.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM F/IM NAILS-STER
FDA Adverse Event
Injury
·SYNTHES USA·Product code HSB·September 20, 2013
4.0MM TI LOCKING SCREW W/T25 STARDRIVE 44MM F/IM NAILS-STER
FDA Adverse Event
Injury
·SYNTHES USA·Product code HSB·September 20, 2013
SCREW,FIXATION,BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·May 18, 2015
HYDRATOME RX SPHINCTEROTOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 15, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 10, 2011
TI NUT 11MM WIDTH ACROSS FLATS
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·July 1, 2013
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·August 27, 2015
5.0MM TI LOCKING SCREW W/T25 STARDRIVE 56MM FOR IM NAILS
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·April 11, 2018
EVOLUT PRO TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·September 30, 2022
QUATTRO® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE HEPARIN E
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code NCX·December 30, 2024
GUIDEWIRE
FDA Adverse Event
Malfunction
·ARGON MEDICAL DEVICES, INC.·Product code DQX·December 30, 2024
Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 23, 2025