13 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Edge™ Diamond R010M Round
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172016858·Diamond dental bur, reusable
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981035·anteriors; shade A2; mould BM6
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668112281·SURG-I-BAND GREY
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756028165·SELF CLOSURE ELASTIC BANDAGE
Gibralt Spine System
FDA UDI
Choice Spine, LP·00840996169899·GIBRALT,TAP,3.5
AOS Small Fragment Plating System Lite
FDA 510(k)
FDA Class 2
·Orthopedic
AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2
FDA 510(k)
FDA Class 2
·Cardiovascular
PANORAMA TIM
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·January 29, 2013
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 5, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·February 2, 2011
Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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