25 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SPRINT PNS System
FDA 510(k)
FDA Class 2
·Neurology
Kompressor™ Compression Screw System
FDA UDI
Ascension Orthopedics, Inc.·10381780280118·STANDARD SOLID LEADING DRIVER
Kompressor Compression Screw System
FDA UDI
Smith & Nephew, Inc.·00885556868997·EXTRACTION DRIVER
ALEUTIAN® Interbody Systems
FDA UDI
VB Spine LLC·10888857320840·Removal Tool Size 7 mm
Integra®
FDA UDI
INTEGRA PAIN MANAGEMENT·10381780260608·EPIDURAL PAINPAK
Integra®
FDA UDI
INTEGRA PAIN MANAGEMENT·10381780429753·Epidural Painpak
EASYPOINT
FDA Adverse Event
Malfunction
·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·June 15, 2023
EASYPOINT
FDA Adverse Event
Malfunction
·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·June 15, 2023
FUTURA TOPCAP NON GAMMA-2
FDA 510(k)
FDA Class 2
·Dental
SIMMETRY(TM) SACROILIAC JOINT FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CASPIAN Spinal System
FDA UDI
VB Spine LLC·10888857235427·DENALI®Mini Screw Alignment Guide Mini DENALI®
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
HEARTWARE® VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Malfunction
·HEARTWARE, INC·Product code DSQ·October 29, 2014
PINN MAR NEUT 28IDX46OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·August 10, 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
Deltec Cozmo Insulin Pump, Model 1800 Smiths Medical International Ltd WD24 4LG UK, Smiths Medical MD, Inc., St Paul, MN 55112. This Pump is similar to the currently distributed Deltec Cosmo Insulin Pump Model 1700 pump, with the exception of updated software that enhanced certain features and added a food data base to allow users to better manage dietary requirements in conjunction with the use of their insulin pump. REF 21-1801-81, 21-1803-81, 21-1805-49/51/81, 21-1806-51/81, 21-1807-49
FDA Recall
Terminated
·Smiths Medical MD, Inc.·Product code LZG·March 10, 2008