80 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·November 24, 2021
Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005
FDA Enforcement
Class II
·Terminated·CooperSurgical, Inc.·June 18, 2014
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·November 24, 2021
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·November 24, 2021
LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·November 24, 2021
LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·November 24, 2021
COOPER SURGICAL Milex PESSARY, RING MILEX INCONT FLEXIBLE SZ6 1 3/4" Catalog # MXPCON06
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes. Model: 61-3005
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·December 13, 2023
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes Model: 61-4005
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·December 13, 2023
Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.
FDA Enforcement
Class II
·Terminated·Cooper Surgical, Inc.·April 3, 2013
LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop is used to cut out abnormal cervical tissue. The cartridges of Polocaine and Xylocaine with Epinephrine contained in the LEEP RediKit are local anaesthetic which the physician may choose from during the procedure.
FDA Enforcement
Class II
·Terminated·Cooper Surgical, Inc.·April 10, 2013
Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy
FDA Enforcement
Class II
·Terminated·Cooper Surgical, Inc.·December 5, 2012
Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy
FDA Enforcement
Class II
·Terminated·Cooper Surgical, Inc.·December 5, 2012
Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB probe is for obstetrical use in the labor and department for late term obstetrical examination associated with larger women. The product detects fetal heart beats as an aid for determining fetal viability.
FDA Enforcement
Class II
·Terminated·CooperSurgical, Inc.·March 28, 2018
ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee Cannula (CooperSurgical Product Code: ESPX5) is a sterile, single-use cannula that is part of the Advanced Endosee System. The cannula contains a light source and a camera at the distal end, which can be used for live visualization. The camera can also capture video and images of the diagnostic area for later diagnostic analysis. The Advanced Endosee Cannulas (P/N: ESPX5) are sold in boxes of 5 units/box. Quantities presented are by box.
FDA Enforcement
Class II
·Terminated·CooperSurgical, Inc.·January 22, 2020
ROSA Surgical Device 2.5.8 It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·November 29, 2017
CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant Heal Warmer, P/N 2440 To provide gentle heat to increase blood flow and enhance infant blood sample collection
FDA Enforcement
Class II
·Terminated·CooperSurgical, Inc.·March 25, 2015
Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows : CooperSurgical PN 20418 WARMGEL INFANT HEEL WARMER - PRISM BOX OF 100; PN 24401 LIQUID INFANT HEEL WARMER - PRISM BOX OF 100; and Fisher Brand. PN 24647 FISHERBRAND GEL INFANT - HEEL WARMER BOX OF 100; PN 24646 FISHERBRAND LIQUID INFANT - HEEL WARMER- 100 PER BOX
FDA Enforcement
Class II
·Terminated·CooperSurgical, Inc.·July 29, 2015
CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.
FDA Enforcement
Class II
·Terminated·CooperSurgical, Inc.·September 17, 2014
ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0
FDA Enforcement
Class II
·Terminated·CooperSurgical, Inc.·May 29, 2019