13 results
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23ms
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Sources: EU EUDAMED, US FDA
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Country: United States
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FDA UDI
MAKO SURGICAL CORP.·00848486020514·ACETABULAR REAMER ¿ 52mm
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5821602710·SCISSORS, SURGICAL TISSUE, DENTAL
Denovo general purpose dental molar band
FDA UDI
Denovo Dental, Inc.·00810059290648·Denovo general purpose dental molar band - Mand...
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221044921·Unitek(TM) Molar Band General Purpose Narrow Re...
VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
SPIRALOK ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·January 16, 2009
OSSIX BONE, OSSIX PLUS
FDA Adverse Event
Injury
·DATUM DENTAL LTD.·Product code NPM·June 22, 2022
TMJ BILATERAL IMPLANTS
FDA Adverse Event
Injury
·TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS·Product code LZD·October 17, 2022
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2013
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008
COULTER LH750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·June 2, 2011
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