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Gyrus ACMI Corporation

13 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
MICRON BOBBIN VENT TUBE, 1.27 MM I.D., TITANIUM, REF 145281-ENT, QTY 1, STERILE EO, GYRUS recall (Z-0797-2010)Gyrus ACMI Corporation2010-03-04
Gyrus ACMI PKS Seal Open Forceps, model 3103PK, 9-3/4" curved. Sterile EO. The device is i recall (Z-0632-2010)Gyrus ACMI Corporation2010-01-14
Gyrus ACMI PKS Seal Open Forceps, model 3104PK, 9-3/4" straight. Sterile EO. The device is recall (Z-0633-2010)Gyrus ACMI Corporation2010-01-14
Gyrus ACMI PKS Seal Open Forceps, model 3104PK, 9-3/4" angled. Sterile EO. The device is i recall (Z-0634-2010)Gyrus ACMI Corporation2010-01-14
Gyrus ACMI PKS Seal Open Forceps, model 915000PK, 9-3/4" Curved Jaw. Sterile EO. The devic recall (Z-0635-2010)Gyrus ACMI Corporation2010-01-14
Gyrus ACMI PKS Seal Open Forceps, model 915005PK, 9-3/4" Straight Jaw. Sterile EO. The dev recall (Z-0636-2010)Gyrus ACMI Corporation2010-01-14
Gyrus ACMI PKS Seal Open Forceps, model 915010PK, 9-3/4" Angled Jaw. Sterile EO. The devic recall (Z-0637-2010)Gyrus ACMI Corporation2010-01-14
Gyrus ACMI, Inc. dissector PlasmaKnife (DPK) Catalog No: 7035-3005 A single use only bipol recall (Z-0273-2009)Gyrus ACMI Corporation2008-11-05
Gyrus ACMI 10 Fr. Dual Lumen Catheter Reference Number: 608 BX (Box of 5) and 608 (single recall (Z-2226-2008)Gyrus ACMI Corporation2008-09-16
Gyrus CyberWand Ultrasonic Lithotripter System includes: CW-USLS CyberWand USL System CW-U recall (Z-1073-2007)Gyrus ACMI Corporation2007-08-09
Gyrus ACMI Tripolar Ultra Cutting Forceps: 5 mm X 32 cm-Reference Number: TRU5-32 recall (Z-0613-2007)Gyrus ACMI Corporation2007-03-13
Gyrus ACMI Tripolar Ultra Cutting Forceps: 10 mm X 32 cm-Reference Number: 006689-901 recall (Z-0614-2007)Gyrus ACMI Corporation2007-03-13
Gyrus ACMI Tripolar Ultra Cutting Forceps: 10 mm X 32 cm w/rotation-Reference Number: 0066 recall (Z-0615-2007)Gyrus ACMI Corporation2007-03-13

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