11 results
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17ms
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Sources: EU EUDAMED, US FDA
ORTHO ALT MICROWELL TEST SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471156050·K-WIRE - SINGLE TROCAR 1.1mm DIA x 230mm
TROJAN NIRVANA COLLECTION LUBRICATED CONDOMS
FDA Adverse Event
Injury
·CHURCH & DWIGHT CO., INC.·Product code HIS·June 24, 2020
DR 400
FDA 510(k)
FDA Class 2
·Radiology
ARCHITECT STAT TROPONIN-I IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EMAX 2 MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·January 31, 2013
EASYSPRAY CE OPTIMIZED DESIGN
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - VIENNA·Product code FMF·December 29, 2010
UNKNOWN_SPINE_PRODUCT
FDA Adverse Event
Malfunction
·STRYKER SPINE-FRANCE·Product code KWP·July 17, 2014
Ingenuity CT 728326 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·December 14, 2016
Philips Ingenuity CT computed tomography x-ray system
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 14, 2018
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026