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Cooper Surgical, Inc.

30 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-vo recall (Z-1053-2013)Cooper Surgical, Inc.2013-04-03
Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Int recall (Z-1018-2013)Cooper Surgical, Inc.2013-03-28
Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4", 70mm. Milex Part Number: MX recall (Z-1004-2013)Cooper Surgical, Inc.2013-03-27
Cooper Surgical Incontinence Dish w/ Support Pessary #5, 80mm. Milex :Part Number: MXPCOND recall (Z-1005-2013)Cooper Surgical, Inc.2013-03-27
Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm. Milex Part Number: MXKPCOND recall (Z-1006-2013)Cooper Surgical, Inc.2013-03-27
Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number: MXKPCOND00 recall (Z-1007-2013)Cooper Surgical, Inc.2013-03-27
Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Number: MXPCOND00 A recall (Z-1008-2013)Cooper Surgical, Inc.2013-03-27
Cooper Surgical Gellhorn Flexible Pessary -2 3/4", 70mm. Milex Part Number: MXPGE2-3/4 A p recall (Z-1009-2013)Cooper Surgical, Inc.2013-03-27
Cooper Surgical Gellhorn Flexible Pessary 3", 76mm. Milex Part Number: MXPGE3- A pessary i recall (Z-1010-2013)Cooper Surgical, Inc.2013-03-27
Cooper Surgical Cube Pessary 1 5/8"", 41mm. Milex Part Number: MXKPEC04 A pessary is a med recall (Z-1011-2013)Cooper Surgical, Inc.2013-03-27
Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm. Milex Part Number: MXKPECH00 A recall (Z-1012-2013)Cooper Surgical, Inc.2013-03-27
Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended us recall (Z-0439-2013)Cooper Surgical, Inc.2012-11-26
Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 The inten recall (Z-0440-2013)Cooper Surgical, Inc.2012-11-26
DICOM Option for the Norland Illuminatus Software Revs 4.2.0 though 4.3.1. Models Norland recall (Z-0213-2012)Cooper Surgical, Inc.2011-11-18
Wallach LL100 Cryosurgical Freezer CO2 Unpinned Yoke System CO2 Model: 900000. recall (Z-0091-2010)Cooper Surgical, Inc.2009-10-29
Wallach LL100 Cryosurgical Freezer CO2 System Model: 9000002X. recall (Z-0092-2010)Cooper Surgical, Inc.2009-10-29
Wallach LL50x Cryosurgical Freezer CO2 System Model: 900007. recall (Z-0093-2010)Cooper Surgical, Inc.2009-10-29
Wallach LL50x Cryosurgical Freezer CO2 Unpinned Yoke System Model: 900010. recall (Z-0094-2010)Cooper Surgical, Inc.2009-10-29
Wallach LL100 Cryosurgical Freezer No Gas Fitting CO2 System Model: 900019x. recall (Z-0095-2010)Cooper Surgical, Inc.2009-10-29
Wallach LL100 Cryosurgical Freezer Short Shaft CO2 System Model: 900034. recall (Z-0096-2010)Cooper Surgical, Inc.2009-10-29
Wallach LL100 Cryosurgical Freezer Atom CO2 System Model: 900036. recall (Z-0097-2010)Cooper Surgical, Inc.2009-10-29
Wallach LL100 Cryosurgical Freezer CO2 System Model: 900043. recall (Z-0098-2010)Cooper Surgical, Inc.2009-10-29
Wallach LL100 Cryosurgical Freezer No Connector CO2 System Model: 900047. recall (Z-0099-2010)Cooper Surgical, Inc.2009-10-29
Wallach LL100 Cryosurgical Freezer CO2 System Model: 900107. recall (Z-0100-2010)Cooper Surgical, Inc.2009-10-29
WA 1000A with Blank Console Model: 900506x. recall (Z-0101-2010)Cooper Surgical, Inc.2009-10-29
WA 4000 Console Model: 900509x. recall (Z-0102-2010)Cooper Surgical, Inc.2009-10-29
WA 1000 A/B Console Model: 900516x. recall (Z-0103-2010)Cooper Surgical, Inc.2009-10-29
M-Style Mushroom Cup Vacuum Assisted Delivery System used with hand pump (Ref: 10007LP). P recall (Z-1887-2008)Cooper Surgical, Inc.2008-09-17
M-Style Cup with Universal Vacuum Release (UVR) used with wall suction, Vacuum Assisted De recall (Z-1888-2008)Cooper Surgical, Inc.2008-09-17
Mystic II M-Style Mushroom Cup Vacuum Assisted Delivery System (Ref: 10057). Product is in recall (Z-1889-2008)Cooper Surgical, Inc.2008-09-17

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