15 results · 20ms · 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.

PULL TAB SQUEEZE FLUSH

FDA 510(k)
FDA Class 2 ·Cardiovascular

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496070979·MISS RELAX 140 OPEN TOE, SIZE M, CIPRIA, GRADUA...

REDI-SCREEN

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000

FDA 510(k)
FDA Class 2 ·Hematology

S4C POLYAXIAL SCREW 3.5X12MM

FDA Adverse Event
Malfunction ·AESCULAP AG & CO. KG·Product code MNI·May 1, 2009

NV GXL LINR, NTRL, 32MM ID, GROUP 2 CUPS

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code MEH·July 20, 2022

NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JDI·July 9, 2024

OMNIPOD INSULIN PUMP

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code LZG·March 29, 2013

ACTICON NEOSPHINCTER

FDA Adverse Event
Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code MIP·April 19, 2011

UNKNOWN ZIMMER TM REVERSE GLENOSPHERE

FDA Adverse Event
Malfunction ·ZIMMER, INC.·Product code HSD·July 3, 2008

NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JDI·October 11, 2024

NV GXL LINR, NTRL, 36MM ID, GROUP 3 CUPS

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JDI·October 28, 2024

The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022