16 results
·
21ms
·
Sources: EU EUDAMED, US FDA
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
FDA 510(k)
FDA Class 2
·General Hospital
Endo GIA
FDA UDI
Covidien LP·10884523002935·Universal Loading Unit
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482043691·Symmetry® Scissors, Operating, Straight, Sharp/...
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756046077·Myocardial Probe Non-Pyrogenic
ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE
FDA 510(k)
FDA Class 2
·Cardiovascular
OIS-2500 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
PEN NDL 32G 4MM PRO 100 BOX 1200 US
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·December 26, 2024
PEN NDL 32G 4MM PRO 100 BOX 1200 US
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·March 20, 2025
COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 2, 2013
TERUMO CDI 540 CALIBRATOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·March 7, 2011
ACCESS2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·April 17, 2008
SATELLITE SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH·Product code NVR·May 5, 2011
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
LIFEPAK CR(R) PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·December 21, 2017
ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
FDA Enforcement
Class II
·Terminated·Arjo Hospital Equipment AB·October 15, 2014
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
FDA Enforcement
Class II
·Terminated·Care Essentials Pty., Ltd.·February 12, 2020