14 results · 21ms · Sources: EU EUDAMED, US FDA

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WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ArgenZ HT+ 98x10 D4

FDA UDI
ARGEN CORPORATION, THE·D818121987·Dental porcelain/ceramic restoration kit

BD ULTRA-FINE¿ SHORT PEN NEEDLES 8MM (5/16¿) 31G

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·December 3, 2019

BD ULTRA FINE¿ PEN NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·February 11, 2020

PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY

FDA 510(k)
FDA Class 2 ·Radiology

COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593

FDA 510(k)
FDA Class 2 ·Cardiovascular

IPP INFLATABLE PENILE PROSTHESIS

FDA Adverse Event
Injury ·MENTOR UROLOGY, INC.·Product code FHW·November 8, 1996

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OYC·May 21, 2013

SPRINT QUATTRO SECURE

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 13, 2011

M SERIES

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·August 13, 2008

3 ML BD LUER-LOK LUER-LOK TIP

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FMF·July 9, 2020

PLATE ADAPTER DIST. LAT. FEMUR RIGHT

FDA Adverse Event
Malfunction ·STRYKER GMBH·Product code HWC·May 11, 2017

Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

FDA Enforcement
Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015