Gyrus Acmi, Incorporated

8 FDA 510(k) clearances · Recalling firm

Record	Firm	Date
Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 recall (Z-0419-2015)	Gyrus Acmi, Incorporated	2015-06-26
Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, an recall (Z-1752-2015)	Gyrus Acmi, Incorporated	2015-06-11
Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, an recall (Z-1753-2015)	Gyrus Acmi, Incorporated	2015-06-11
GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, S recall (Z-1439-2013)	Gyrus Acmi, Incorporated	2013-05-31
PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRU recall (Z-0411-2013)	Gyrus Acmi, Incorporated	2012-11-20
Gyrus ACMI, REF 25 BX, PTFE Coated 3 cm Flexible Tip Guidewire, .035" x 150 cm, Sterile EO recall (Z-2383-2011)	Gyrus Acmi, Incorporated	2011-05-26
GYRUS ACMI, dissector PlasmaKnife" , REF 7035-3005, Rx only, STERILE R, CE 0344, 161416-CA recall (Z-2651-2010)	Gyrus Acmi, Incorporated	2010-09-30
The Gyrus ACMI Pleatman Sac Tissue Removal System facilitates removal of specimens while m recall (Z-2436-2010)	Gyrus Acmi, Incorporated	2010-09-19

Every clearance here is in the API, with alerts when new ones post.