14 results
·
21ms
·
Sources: EU EUDAMED, US FDA
EPX-4440HD and EPX-4400HD with FICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Oticon
FDA UDI
Oticon A/S·05707131286468·H16V2 TI, MINIRITE 312 WL SIL
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011150221000·O-Tray impression tray for Mandibular, Size L1
HEMOSIL SILICA CLOTTING TIME
FDA 510(k)
FDA Class 2
·Hematology
INTELLIWAVE3
FDA 510(k)
FDA Class 2
·Ophthalmic
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code LZG·May 31, 2018
T:SLIM G5 SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OYC·July 5, 2019
SPECTRANETICS QUICK-CROSS SUPPORT CATHETER
FDA Adverse Event
Injury
·THE SPECTRANETICS CORPORATION·Product code DQY·March 6, 2019
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 5, 2015
MAQUET SAS
FDA Adverse Event
Malfunction
·MAQUET SAS·Product code FTD·May 1, 2013
GYNNIE OB-GYN STRETCHER
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code HDD·June 10, 2011
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
FDA Adverse Event
Injury
·BIOENTRICS CORP·Product code LTI·September 3, 2008
Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
FDA Enforcement
Class II
·Ongoing·DJO, LLC·December 3, 2025
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