International Medical Devices Database

Manufacturer Address
Gyrus ACMI Corporation, 136 Turnpike Rd, Southborough MA 01772-2118
Source
USFDA
10 Events

5 devices in the database

Device Recall Micron Bobbin Vent Tube

Model / Serial
Lot Number: MH136952.
Product Classification
Ear, Nose, and Throat Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution -- Including states of FL, GA, OH, TX, RI, IL, MI, and KS.
Product Description
MICRON¿ ¿ BOBBIN VENT TUBE, 1.27 MM I.D., TITANIUM, REF 145281-ENT, QTY 1, STERILE EO, GYRUS ACMI INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01772 USA. || Intended to be implanted for ventilation or drainage of the middle ear.

Gyrus ACMI PKS Seal Open Forceps.

Model / Serial
all lots
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
US and International distribution. OUS to Include: Australia, Belgium, Bolivia, Bulgaria, Canada, Chile, China, Columbia, Croatia, Czech, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece , Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Panama, Puerto Rico, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom.
Product Description
Gyrus ACMI PKS Seal Open Forceps, model 915010PK, 9-3/4" Angled Jaw. Sterile EO. The device is intended to be used with the G400 electrosurgical generator. Gyrus ACMI, Inc., 136 Turnpike Road, Southborough, MA 01772-2104 USA.

Device Recall Gyrus ACMI

Model / Serial
Lot Nos: 6236022, 6236023, 6236024
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution ----USA and countries of Canada, The Netherlands, Japan, Portugal, Columbia, South Africa, Australia, and Spain.
Product Description
Gyrus ACMI Tripolar Ultra Cutting Forceps: 10 mm X 32 cm w/rotation-Reference Number: 006689-903

Device Recall Gyrus ACMI

Model / Serial
Lot Nos.: 6258014, 6303028, 6306017, 6312602, 6314021, 6320034, 6326096, 6335040, 6342010, 6362025, 7004015, 7009015
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution ----USA and countries of Canada, The Netherlands, Japan, Portugal, Columbia, South Africa, Australia, and Spain.
Product Description
Gyrus ACMI Tripolar Ultra Cutting Forceps: 10 mm X 32 cm-Reference Number: 006689-901

Device Recall Gyrus ACMI

Model / Serial
Lot Nos. : 6236019, 6236020, 6236021, 6258015, 6297001, 6300013, 6306015, 6320041, 6326021, 6326097, 6335042, 6342008, 6349001, 6349002, 6355029, 7011002, 7011003, 7019012
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution ----USA and countries of Canada, The Netherlands, Japan, Portugal, Columbia, South Africa, Australia, and Spain.
Product Description
Gyrus ACMI Tripolar Ultra Cutting Forceps: 5 mm X 32 cm-Reference Number: TRU5-32

2 manufacturers with a similar name

Learn more about the data here

Gyrus ACMI Corporation

Manufacturer Address
Gyrus ACMI Corporation, 136 Turnpike Road, Southborough MA 01772-2118
Source
USFDA

Gyrus ACMI Corporation

Manufacturer Address
Gyrus ACMI Corporation, 136 Turnpike Road, Southborough MA 01772
Manufacturer Parent Company (2017)
Olympus Corporation
Source
USFDA

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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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