29 results · 30ms · Sources: EU EUDAMED, US FDA

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ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

SW

FDA UDI
SW SAFETY SOLUTIONS INC.·00616489125563·PowerChem Neoprene Exam Gloves, Extra Extra Large

KMEDIC

FDA UDI
TELEFLEX INCORPORATED·24026704293951·

Key Surgical K-Wires and Steinmann Pins

FDA UDI
KEY SURGICAL, INC.·00849771015178·Steinmann Pins, Single diamond, threaded, 7/64-...

NA

FDA UDI
KEY SURGICAL, INC.·10849771050022·Steinmann Pins, Single diamond, threaded, 7/64-...

WMT MODULAR SHOULDER SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

FLEXICAST PRIME

FDA 510(k)
FDA Class 2 ·Dental

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 11, 2025

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 3, 2025

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 23, 2025

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 27, 2024

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 8, 2022

880 HUMIDIFICATION SYSTEM

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 31, 2010

ADVISOR VITAL SIGNS MONITOR

FDA Adverse Event
Malfunction ·SMITHS MEDICAL PM, INC.·Product code CCK·December 24, 2008

ADVISOR VITAL SIGNS MONITOR

FDA Adverse Event
Malfunction ·SMITHS MEDICAL PM, INC·Product code DQK·April 28, 2010

ATTAIN ABILITY PLUS

FDA Adverse Event
Injury ·MPRI·Product code OJX·April 22, 2013

ASR ACETABULAR CUPS 46

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 15, 2011

840 VENTILATOR

FDA Adverse Event
Malfunction ·PURITAN-BENNETT CORP·Product code CBK·July 9, 2008

880 HUMIDIFICATION SYSTEM

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD.·Product code BTT·February 15, 2010

RESPIRATORY HUMIDIFIER

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 12, 2024