44 results · 21ms · Sources: EU EUDAMED, 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