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Manufacturers
Encision, Inc.
Manufacturer Address
Encision, Inc., 4828 Sterling Drive, Boulder CO 80301
Source
USFDA
4 Events
Recall of Device Recall Active Electrode Monitoring System
Recall of Device Recall Active Electrode Monitoring System
Recall of Device Recall Active Electrode Monitoring System
Recall of Device Recall Monopolar Laparoscopic Electrode
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4 devices in the database
Device Recall Active Electrode Monitoring System
Model / Serial
Catalog number EM2M NC, all serial numbers
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
CA, IL, KS, OH, OK, PA, TN. No government or military accounts. Foreign distribution to Canada and Italy.
Product Description
EM2M NC AEM Monitor, (NON-COM)
Device Recall Active Electrode Monitoring System
Model / Serial
Catalog number EM2+A NC, all serial numbers.
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
CA, IL, KS, OH, OK, PA, TN. No government or military accounts. Foreign distribution to Canada and Italy.
Product Description
EM2+A NC AEM Monotor (NON-COM)
Device Recall Active Electrode Monitoring System
Model / Serial
Catalog Number EM2 NC, all serial numbers.
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
CA, IL, KS, OH, OK, PA, TN. No government or military accounts. Foreign distribution to Canada and Italy.
Product Description
EM2 NC AEM Monitor (NON-COM)
Device Recall Monopolar Laparoscopic Electrode
Model / Serial
Catalog # ES3521B. Lots FI, GC, GH, GL, HH, HI.
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Domestic distribution to LA, MA, MN, OR, UT and WA.
Product Description
AEM Fixed-Tip Needle Electrode - 5mm, Reusable || REF/CAT ES3521B
2 manufacturers with a similar name
Learn more about the data
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Encision, Inc.
Manufacturer Address
Encision, Inc., 4828 Sterling Dr, Boulder CO 80301-2350
Source
USFDA
Encision, Inc.
Manufacturer Address
Encision, Inc., 6797 Winchester Cir, Boulder CO 80301-3513
Manufacturer Parent Company (2017)
Encision, Inc.
Source
USFDA
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