14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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