23 results · 25ms · 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.

VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE

FDA 510(k)
FDA Class 2 ·Microbiology

SW

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

Cook

FDA UDI
COOK INCORPORATED·00827002142237·Urethral Meatal Dilator

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0730060·Rod Bender, 5.5 mm, 5 Position

ADVIA CENTAUR HOMOCYSTEINE ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

GUARDED NEEDLE 2000

FDA 510(k)
FDA Class 2 ·General Hospital

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

880 HUMIDIFICATION SYSTEM

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

OMNIGUIDE BEAMPATH FIBER AND ADAPTER

FDA Adverse Event
OMNIGUIDE, INC.·Product code GEX·October 19, 2010

SM104 M-SERIES W/5TH WHEEL

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·April 23, 2013

ACCESS® 2 IMMUNOASSAY SYSTEM

FDA Adverse Event
Injury ·BECKMAN COULTER INC.·Product code MMI·May 1, 2011

ISOFLEX P

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·July 11, 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

RESPIRATORY HUMIDIFIER

FDA Adverse Event
Injury ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·July 4, 2024

880 HUMIDIFICATION SYSTEM

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

FISHER & PAYKEL HEALTHCARE

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 6, 2023