16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COULTER LH 750 HEMATOLOGY ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496032342·PERSONALITY 70 SHEER, SIZE 2XXL, NERO, GRADUATE...
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032342·Baltic Denture System BDLoad Mm6 PLSEbim6DFm A1...
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120323421·Diamond, torpedo, COOL DIAMANT, coarse grit, gr...
AMS SOFT-TISSUE APPROXIMATION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 29, 2013
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·March 22, 2011
PERCLOSE PROGLIDE, 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·April 22, 2008
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
EVOLUT FX VALVE
FDA Adverse Event
Injury
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·August 27, 2025
ACCUVUE ADVANCE
FDA Adverse Event
Injury
·VISTAKON·Product code LPL·October 19, 2007
XVWEB
FDA Adverse Event
Injury
·PLANET DDS·Product code LLZ·March 13, 2025
SECOND OPINION
FDA Adverse Event
Injury
·PEARL INC.·Product code MYN·March 13, 2025
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016