18 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT
FDA 510(k)
FDA Class 2
·Hematology
Spherodon - M
FDA UDI
SILMET LTD·07290012207402·Dental Amalgam Capsules
JOBST UltraSheer
FDA UDI
BSN MEDICAL, INC.·00035664214920·USH 30-40 KH CT L SUNT 1 EN FR ES
AF541
FDA UDI
Respironics, Inc.·00606959024489·AF541 Mask with Entrainment Elbow, Leak 1, with...
8 CHANNEL CARDIAC PHASED ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
K-Y BRAND WARMING LIQUID PERSONAL LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·September 5, 2024
NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·September 5, 2024
ALT HA S CLR EXT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code MEH·November 14, 2023
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 19, 2025
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTP·May 21, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 26, 2014
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·June 7, 2011
NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·May 31, 2024
NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·August 12, 2024
BIOLOX DELTA FEMORAL HEAD 32MM OD, -3.5MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·October 3, 2024
NV GXL LINER LIPPED 36MM ID GROUP 2
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·November 1, 2022
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