24 results · 23ms · Sources: EU EUDAMED, US FDA

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POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

PRINCETON

FDA UDI
Princeton Medical Group, Inc.·00810158216570·FORCEPS USA DRESSING STRAIGHT 5"

TEMP IT

FDA 510(k)
FDA Class 2 ·Dental

MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI

FDA 510(k)
FDA Class 2 ·Cardiovascular

OCTRODE LEAD KIT, 60CM LENGTH

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)·Product code LGW·April 12, 2023

OCTRODE LEAD KIT, 60CM LENGTH

FDA Adverse Event
Injury ·ABBOTT MEDICAL·Product code LGW·January 10, 2025

STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code MHY·January 24, 2024

OCTRODE LEAD KIT, 60CM LENGTH

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)·Product code LGW·December 28, 2025

OCTRODE LEAD KIT, 60CM LENGTH

FDA Adverse Event
Injury ·ABBOTT MEDICAL·Product code LGW·May 24, 2023

OCTRODE LEAD KIT, 60CM LENGTH

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)·Product code LGW·April 4, 2024

PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)·Product code LGW·February 26, 2023

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 1, 2011

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013

GEMSTR 7 THPY ALT ST

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·September 16, 2014

ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·August 23, 2011

ADULT INSPIRATORY-HEATED BREATHING CIRCUIT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·October 24, 2011

VENTED AUTOFEED HUMIDIFICATION CHAMBER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·August 11, 2011

VENTED AUTOFEED CHAMBER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 28, 2011

BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 29, 2019

Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

FDA Enforcement
Class II ·Terminated·Pentax of America Inc·August 30, 2017