International Medical Devices Database

Manufacturer Address
Encision, Inc., 4828 Sterling Dr, Boulder CO 80301-2350
Source
USFDA
2 Events
- Recall of Device Recall Disposable AEM Cord
- Recall of Device Recall Fixed Tip Electrosurgical Electrode.

2 devices in the database

Device Recall Disposable AEM Cord

Model / Serial
REF ES4107, Lot Numbers 900032, 0094, HB, HBA, HC, HD, HE, HF, HFA, HG, HI.
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
AL, CA, GA, KS, KY, MI, MN, MS, NC, NH, NY, OH, OK, SD, TN, WA, WY. Foreign Distribution to Australia and Japan. Includes military facilities in GA, MS, and Japan.
Product Description
Encision ES4107 Disposable AEM Cord, Sterile.

Device Recall Fixed Tip Electrosurgical Electrode.

Model / Serial
Catalog ES3511B, Lots EKA, FB, FE, FI, FL, GA, GC, GF, GH, GI, GIA, GL, GLA, HC, HCA, HE.
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
AL, CT, GA, IA, MN, MS, NC, OK, OR, TN, WA. Foreign distribution to Canada and Australia.
Product Description
AEM Fixed-Tip L-Diamond Electrode, 5mm, Reusable.

2 manufacturers with a similar name

Learn more about the data here

Encision, Inc.

Manufacturer Address
Encision, Inc., 4828 Sterling Drive, Boulder CO 80301
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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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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