44 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SPINEWAND SURGICAL DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Bur PM2-70 80K Steel Ø1.0 St
FDA UDI
Bien-Air Surgery SA·17630055503197·
Bur PM2-70 80K steel Ø1.0mm sterile
FDA UDI
Bien-Air Surgery SA·J00711003530011·
Thermo Scientific Pacific Hemostasis®
FDA UDI
Fisher Diagnostics·00845275000528·
Osstell SmartPeg Type 01
FDA UDI
Osstell AB·09010522001165·ISQ Measurement Peg
DYNAMIC AXIAL FIXATOR
FDA UDI
ORTHOFIX SRL·18053504364788·Component. Not for sale. Used for reporting Dir...
STAINLESS STEEL COAXIAL ARCHWIRES
FDA UDI
Ortho Organizers, Inc.·00190707088996·.0175 Upper Stainless Steel Pro Form™ Coaxial A...
Mariner MIS
FDA UDI
Seaspine Orthopedics Corporation·10889981212520·Dual end CT
Tether™
FDA UDI
Seaspine Orthopedics Corporation·10889981035600·Plate - 3 Level - 53mm
WAVEWRITER ALPHA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 25, 2023
MATTIOLI PULSE TWO/THREE PLUS FAMILY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MED-LOGICS DISPOSABLE ALK TUBING
FDA 510(k)
FDA Class 1
·Ophthalmic
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·May 8, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 18, 2014
INTERSTIM II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·May 13, 2011
CONCERTO NYLON
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRD·January 26, 2021
DISPOSABLE STERILE HIGH TEMPERATURE ELECTROCAUTERY (HTC) F7244
FDA Adverse Event
Injury
·FIAB SPA·Product code GEI·October 12, 2023
SOMATOM Confidence -Computed tomography systems Model 10590100
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022
SOMATOM Confidence with software syngo.CT VB20 Model #10590100
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021
Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
FDA Enforcement
Class II
·Terminated·Primus Corporation·November 11, 2020