20 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BLUEDIAMOND IMPLANT, Abutment Screw
FDA 510(k)
FDA Class 2
·Dental
VITA TITANKERAMIK
FDA UDI
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft·J017B2118120·VITA TITANKERAMIK INTENSIVE, IN8, 12 g
NuVasive
FDA UDI
Nuvasive, Inc.·00195377046680·NTS Slot Tube, 18x120mm Beveled
NA
FDA UDI
Synthes GmbH·10886982151506·2.4MM CANNULATED SCREW LONG THREAD 12MM
ARKEO, Wedge Fixation System
FDA UDI
Auxano Medical LLC·00850055649767·ARKEO Evan's Wedge, 18x18x12
Diamond Orthopedic, LLC
FDA UDI
DIAMOND ORTHOPEDIC, LLC·B551DMD2118120·2.4mm, Cannulated Screw, Long Thd., 12mm
Medical Facets NC
FDA UDI
MEDICAL FACETS NC LLC·M933MDF2118120·2.4mm Cannulated Screw, Long Thread, 12mm
SPECTRUM VENTRICULAR CATHETER
FDA 510(k)
FDA Class 2
·Neurology
SONIXGPS
FDA 510(k)
FDA Class 2
·Anesthesiology
BEBACK CROSSING CATHETER
FDA Adverse Event
Malfunction
·BENTLEY INNOMED GMBH·Product code PDU·December 23, 2025
BEBACK CROSSING CATHETER
FDA Adverse Event
Malfunction
·BENTLEY INNOMED GMBH·Product code PDU·November 21, 2025
BEBACK CROSSING CATHETER
FDA Adverse Event
Malfunction
·BENTLEY INNOMED GMBH·Product code PDU·April 30, 2025
BEBACK CROSSING CATHETER
FDA Adverse Event
Malfunction
·BENTLEY INNOMED GMBH·Product code PDU·March 6, 2025
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code LZG·October 29, 2014
CARE GUARD SHOWER CHAIR WITH BACK
FDA Adverse Event
Malfunction
·INVACARE·Product code INM·August 11, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 8, 2013
DEKA MOTUS AZ
FDA Adverse Event
Malfunction
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·March 8, 2024
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025