15 results
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29ms
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Sources: EU EUDAMED, US FDA
AERONEB GO NEBULIZER, MODEL AG-AG2000
FDA 510(k)
FDA Class 2
·Anesthesiology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032849·Baltic Denture System BDLoad ↓ Mm6 PLSEum2DFm A...
BD PEN NDL¿ 29GA SHIELD BULK
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·March 18, 2019
PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES
FDA 510(k)
FDA Class 1
·Ophthalmic
GLASS POST
FDA 510(k)
FDA Class 1
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 7, 2025
UNKNOWN DEPUY HEAD BALL
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JDI·April 3, 2013
UNICEL® DXC 800 SYNCHRON® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·March 29, 2011
PUMP MMT-715LNAL PRDGM INS V2.1 CL EN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·April 22, 2008
EDWARDS INFLATION DEVICE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code MAV·October 15, 2025
EDWARDS INFLATION DEVICE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code MAV·December 19, 2025
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
EDWARDS INFLATION DEVICE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code MAV·August 16, 2022
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024