11 results
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18ms
·
Sources: EU EUDAMED, US FDA
BIOVIEW MODEL S960000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MICROSPAN SYSTEM
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code FED·June 8, 2006
SYNCHRON URIC ACID
FDA Adverse Event
BECKMAN COULTER INC.·Product code KNK·June 10, 2011
RANDOX LIQUID PROTEIN CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Telemetry Transmitter
FDA 510(k)
FDA Class 2
·Cardiovascular
HEARTSTART XL + DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 16, 2013
VASOVIEW HEMOPRO EVH SYSTEM
FDA Adverse Event
Injury
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·January 11, 2011
MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·July 28, 2014
3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN).
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·June 1, 2016
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025