28 results · 27ms · Sources: EU EUDAMED, US FDA

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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