12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FERTI-LILY Conception Cup
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DTE
FDA UDI
Guilin Woodpecker Medical Instrument Co., Ltd.·06944843657769·Dental X-Ray Device
CLICKFINE PEN NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
UNIVERSAL CERAMIC SOLDER
FDA 510(k)
FDA Class 2
·Dental
23 G X .75 IN. BD VACUTAINER® BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·November 27, 2017
TENDRIL SDX
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2008
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 10, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·July 12, 2013
SpiraLok 5.0 w/out Needles with Orthocord Product Number: 222969 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 5.0 w/out Needles with Orthocord Product Number: 222969 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
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025