15 results · 25ms · Sources: EU EUDAMED, US FDA

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100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES

FDA 510(k)
FDA Class 2 ·Orthopedic

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496070399·BE YOU ICON CURVY, SIZE M-XL, BLU NAVY, GRADUAT...

DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541

FDA 510(k)
FDA Unclassified ·Unknown

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·Product code LGW·November 2, 2021

RINGLOC RIMCUP SHELL

FDA Adverse Event
Injury ·BIOMET SPAIN, S.L.·Product code LPH·August 31, 2017

ASR TAP SLV ADAP 12/14 -1

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD.·Product code KWA·March 17, 2016

MIH MOD CUP INSERTER

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code LXH·August 17, 2017

LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)

FDA Adverse Event
Malfunction ·ALLERGAN·Product code LTI·April 17, 2013

ACCU-CHEK FLEXLINK PLUS

FDA Adverse Event
Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code FRN·April 18, 2011

ONE TOUCH ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code NBW·June 30, 2008

Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

FDA Enforcement
Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

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