16 results · 21ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

SELECT/SP

FDA 510(k)
FDA Class 2 ·Radiology

P.F.C. SIGMA

FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295238898·P.F.C. SIGMA STABILIZED TIBIAL INSERT TRIAL SZ ...

Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters

FDA 510(k)
FDA Class 2 ·Cardiovascular

VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·February 28, 2022

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·October 26, 2022

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·August 22, 2022

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·November 28, 2023

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·April 18, 2023

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·September 25, 2024

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·October 15, 2025

PENTAX

FDA Adverse Event
Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code GCL·October 1, 2024

TANDEM T:SLIM INSULIN DELIVERY SYSTEM

FDA Adverse Event
Injury ·TANDEM DIABETES CARE INC.·Product code LZG·July 30, 2015

DISPOSA-VIEW

FDA Adverse Event
Malfunction ·VITAL SIGNS, INC·Product code CCX·December 29, 2010

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·July 28, 2014

UNIVERSA FIRM URETERAL STENT SET

FDA Adverse Event
Injury ·COOK INC·Product code FAD·March 26, 2018