14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Biobeat Platform, BB-613WP Patch
FDA 510(k)
FDA Class 2
·Cardiovascular
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112885·CORNEAL TREPHINE BLADE6.75MM
CHESAPEAKE® Stabilization System
FDA UDI
VB Spine LLC·10888857082038·3-Screw Titanium Implant, Size 15x18x12 mm
Sapphire II Pro
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955942082·Balloon Dilatation Catheter
ONE TOUCH BASIC
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·January 10, 2002
LOWSLEY SUPRAPUBIC TRACTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
IROOT 100 MINI
FDA 510(k)
FDA Unclassified
·Unknown
BD EMERALD¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·March 30, 2023
THERMACARE LOWER BACK & HIP (THERMACARE HEATWRAP) WRAP
FDA Adverse Event
Malfunction
·PFIZER CONSUMER HEALTH CARE·Product code IMD·July 8, 2011
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 29, 2014
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·July 8, 2013
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456 - Ingenuity TF PET/CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025