21 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST
FDA 510(k)
FDA Class 2
·Hematology
OsteoMed
FDA UDI
OSTEOMED LLC·00845694000451·1.2mm x 2mm Screw
OsteoMed
FDA UDI
OSTEOMED LLC·00845694028844·1.2mm x 2mm Screw, Sterile
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0112020·Tap, 4.75 mm
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0112020·Tap, 4.75mm
ENDOSKELETON® TAS
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00191375051091·Anterolateral 12 Deg Lordotic Rasp, Caddy Lid
OsteoMed
FDA UDI
OSTEOMED LLC·00845694054591·1.2 x 2mm Screw Sterile Qty 5
MSI BIPOLAR SHEATH
FDA 510(k)
FDA Class 2
·Orthopedic
COMPLETE BRAND MULTI-PURPOSE SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
TSRH® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code KWP·April 19, 2013
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC ORTHOPEDIC INC.·Product code KWP·December 4, 2009
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWP·December 4, 2009
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·May 29, 2013
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·April 8, 2013
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·March 29, 2011
ACCU-CHEK ACTIVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS CORP.·Product code LFR·May 9, 2008
TSRH SPINAL SYSTEM
FDA Adverse Event
WARSAW ORTHOPEDIC, INC.·Product code KWP·August 26, 2011
COMPLETE
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code LPN·April 17, 2020
HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Number: 72203706
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·December 18, 2019