ClearanceBrief
Company ยท AU

Go Medical Industries Pty. , Ltd.

FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 2001. Name variants (Inc, Corp, punctuation) are merged.

11510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
5recalls that name a 510(k)

Product codes

CodeDeviceRecords
FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)7
GDMNeedle, Aspiration And Injection, Reusable2
HDBExtractor, Vacuum, Fetal2
FPASet, Administration, Intravascular1
FRNPump, Infusion1
HGEAmniotome1
KODCatheter, Urological1
MEBPump, Infusion, Elastomeric1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jun 6, 2001K011055THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS
Go Medical Industries Pty. , Ltd., AU
FCM
Dec 27, 2000K002803THE O'NEIL STERILE FIELD URINARY CATHETER KIT
Go Medical Industries Pty. , Ltd., AU
FCM
May 9, 2000K000263GO MEDICAL BALLOON INFUSION SYSTEM
Go Medical Industries Pty. , Ltd., AU
MEB
Nov 2, 1993K910007SPRINGFUSOR 10R
Go Medical Industries Pty. , Ltd., AU
FRN
Oct 4, 1990K900336V SET
Go Medical Industries Pty. , Ltd., AU
FPA
Oct 6, 1989K895594SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE
Go Medical Industries Pty. , Ltd., AU
GDM
Sep 12, 1989K890400MODIFIED URINARY CATHETER INTRODUCER (UCI)
Go Medical Industries Pty. , Ltd., AU
KOD
May 11, 1989K891465OBSTETRIC CUP (MODIFICATION)
Go Medical Industries Pty. , Ltd., AU
HDB
Mar 22, 1989K885283ASPIRATING AND IRRIGATING CYSTS NEEDLES
Go Medical Industries Pty. , Ltd., AU
GDM
Apr 15, 1985K850758AMNIGLOVE & AMNICOT
Go Medical Industries Pty. , Ltd., AU
HGE
Apr 25, 1984K840008O'NEIL OBSTETRIC CUP
Go Medical Industries Pty. , Ltd.
HDB

Latest recalls

DateFirm and productCodeLinked 510(k)
Oct 21, 2011Go Medical Industries Pty., Ltd.
O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF:
Terminated		 FCMK002803
Oct 21, 2011Go Medical Industries Pty., Ltd.
O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF:
Terminated		 FCMK002803
Oct 21, 2011Go Medical Industries Pty., Ltd.
O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF:
Terminated		 FCMK002803
Oct 21, 2011Go Medical Industries Pty., Ltd.
O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF:
Terminated		 FCMK002803
Oct 21, 2011Go Medical Industries Pty., Ltd.
O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF:
Terminated		 FCMK002803
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