12 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical
FDA 510(k)
FDA Class 2
·Orthopedic
KLOCKNER DENTAL IMPLANT ABUTMENTS
FDA 510(k)
FDA Class 2
·Dental
Tixel System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 14, 2025
LEEP PRECISION GENERATOR
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code HGI·February 28, 2020
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 3, 2024
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008
NA
FDA Adverse Event
Injury
·NA·Product code FTL·August 20, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 12, 2013
SpiraLok 6.5 w/out Needles with violet and blue Orthocord Product Number: 222988 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
FDA Enforcement
Class II
·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·October 31, 2012
SpiraLok 6.5 w/out Needles with violet and blue Orthocord Product Number: 222988 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
FDA Recall
Terminated
·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code HWC·September 6, 2012
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018