17 results
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20ms
·
Sources: EU EUDAMED, US FDA
OXTI INFLATION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
Z Liquid HT C2-S 100ml
FDA UDI
ARGEN CORPORATION, THE·D818122152·Dental porcelain/ceramic restoration kit
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973097·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172971215·
AEQUALIS ASCEND FLEX SHOULDER PROSTHESIS
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·August 28, 2018
AEQUALIS REVERSED PROSTHESIS
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·August 28, 2018
HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
FDA 510(k)
FDA Class 2
·Cardiovascular
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 15, 2022
OPT SLEEVE 12X100 STABILITY
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·September 24, 2019
CATALYS PRECISION LASER SYSTEM
FDA Adverse Event
Injury
·OPTIMEDICA CORPORATION·Product code OOE·May 17, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS(SLC)·Product code JAA·September 19, 2014
ADVANIX¿ BILIARY STENT WITH NAVIFLEX¿ RX DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code FGE·June 13, 2011
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·May 30, 2025
PINN SECTOR W/GRIPTION 60MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LZO·May 30, 2025
ALTRX +4 10D 36IDX60OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·May 30, 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