12 results
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24ms
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Sources: EU EUDAMED, US FDA
PULMONE MINIBOX PFT TM
FDA 510(k)
FDA Class 2
·Anesthesiology
Allied Medical LLC
FDA UDI
Allied Medical, LLC·00026072002483·Specimen Bag
ELATION® MB
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K133551621·ELATION® MB Base Rx 018 UL/5-5 CS-BC HK
SPACELABS ARKON ANESTHESIA WORKSTATION
FDA 510(k)
FDA Class 2
·Anesthesiology
LEGIONELLA PNEUMOPHILA IGG/IGM
FDA 510(k)
FDA Class 2
·Microbiology
AMISTEM H HA COATED STD STEM SIZE 00
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 20, 2018
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Injury
·INVACARE TAYLOR STREET·Product code IOR·May 29, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 18, 2011
GEMSTAR PUMP SET WITH 0.2MICRON FILTER AND PA-ASV
FDA Adverse Event
Malfunction
·HOSPIRA DE COSTA RICA LTD.·Product code FRN·August 22, 2008
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024