14 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Instylla Delivery Kit
FDA 510(k)
FDA Class 2
·General Hospital
Reverse-Cyte 3% (A1, A2, B)
FDA UDI
Medion Grifols Diagnostics AG·07640137340308·Reagent Red Blood Cells for confirmation of ABO...
ELMED
FDA UDI
ELMED INCORPORATED·00842180124554·5 MM DIA., 36 CM INSULATED BALL TIP ELECTRODE,...
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·August 26, 2021
2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035
FDA 510(k)
FDA Class 2
·Cardiovascular
DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
UNKNOWN ADAPTER
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LPH·March 10, 2025
BIOLOX OPTION TYPE 1 TPR SLEVE +6
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code JDI·March 13, 2025
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code HQL·August 16, 2011
NOVATION CERAMIC CLUSTER HOLE SHELL
FDA Adverse Event
Malfunction
·EXACTECH, INC.·Product code KWB·September 25, 2014
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013
HEMOSPHERE FORESIGHT MODULE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code MUD·February 26, 2026
TPRLC 133 T1 PPS HO 16X152MM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LZO·March 10, 2025
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021