11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
MAKO SURGICAL CORP.·00848486003159·ACETABULAR REAMER ¿ 58mm
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221044983·Unitek(TM) Molar Band General Purpose Narrow Re...
Denovo chairside space maintainer crown
FDA UDI
Denovo Dental, Inc.·00810059290709·Denovo general purpose dental molar band - Mand...
BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RAPIDPOINT 405 NEONATAL BILIRUBIN
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SPRINT QUATTRO
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2013
COULTER LH 780 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·June 2, 2011
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008
AIMING ARM FOR SUPRAPATELLAR
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code JDS·April 6, 2021
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024