30 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KRONNER LOW PROFILE SCOPE HOLDER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Preat
FDA UDI
Preat Corporation·00842092169643·ASC NobelBiocare™ Tri-Lobe-compatible WP Engagi...
PowerPICC SOLO
FDA UDI
Bard Access Systems, Inc.·00801741129742·Catheter Placement Kit
Legion
FDA UDI
Smith & Nephew, Inc.·00885556767290·OXINIUM LEGION HK FEMORAL SIZE 4 LEFT
Legion
FDA UDI
Smith & Nephew, Inc.·00885556767313·OXINIUM LEGION HK THREADED AXLE
...
Legion
FDA UDI
Smith & Nephew, Inc.·00885556767306·OXINIUM LEGION HK TITANIUM TIBIAL
...
FlowLogic Assert
FDA UDI
SONENDO, INC.·00810209420451·FlowLogic Assert Shaping File 10/.04, 31mm
RTE SNAPCONE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FHW·July 11, 2023
GO MEDICAL BALLOON INFUSION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
PM 2002 PROLINE/AEC
FDA 510(k)
FDA Class 2
·Dental
REAR TIP EXTENDER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code N/A·December 30, 2025
RTE SNAPCONE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FHW·February 17, 2021
TUF TT IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·June 25, 2024
RESERVOIR 1.8ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·March 12, 2013
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 16, 2011
IAB: 8 FR 40 CC
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·February 15, 2008
TECA® DISP DMN NEEDLE ELECTRODE, 1"(25MM)X0.36MM
FDA Adverse Event
Malfunction
·NATUS MANUFACTURING LIMITED·Product code IKT·October 30, 2024
PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics.
FDA Enforcement
Class II
·Terminated·PTW-Freiburg·September 2, 2015
BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015
BrightView, Gamma Camera System, Product Code 882480.
FDA Enforcement
Class II
·Ongoing·Philips North America·January 17, 2024