14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Half Dome Posterior Lumbar Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169524262·TRIAL 2152512 MEDIUM 12 DEGREES 12MM
Eagle Derma2 Nitrile Examination Gloves
FDA UDI
Eagle Protect Pbc·09421024254667·Derma2 Nitrile Examination Gloves, Black, Powde...
LEONE SPA
FDA UDI
LEONE SPA·08033707014300·CALIBRA 1ST MOL BANDS W/G8325-02 n.UR 12
INNESIS PEEK CERVICAL CAGE
FDA UDI
BK MEDITECH CO.,LTD.·08809763504716·Distraction Screw
VANISHPOINT BLOOD COLLECTION SET
FDA 510(k)
FDA Class 2
·General Hospital
RMS SUBCUTANEOUS NEEDLE SET
FDA 510(k)
FDA Class 2
·General Hospital
OPT SLEEVE 12X100 STABILITY
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·September 24, 2019
S-ICD SYSTEM
FDA Adverse Event
Injury
·CAMERON HEALTH·Product code NVY·June 17, 2014
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DXY·June 7, 2013
RUSCH ET. TUBE REINFORCE CUFFED NASORAL 6.5MM
FDA Adverse Event
Malfunction
·WILLY RUESCH GMBH·Product code BTR·June 21, 2011
Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638, AMS3711, AMS4212, PSS1852(A, convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021