13 results
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28ms
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Sources: EU EUDAMED, US FDA
Redermax Antibacterial Wound Matrix
FDA 510(k)
FDA Unclassified
·Unknown
CVS Soft Grip Contact Lens Case
FDA UDI
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED·00050428379967·Contact lens case for storage of soft, rigid ga...
CVS Soft Grip Contact Lens Case
FDA UDI
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED·00050428274767·Contact lens case for storage of soft, rigid ga...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776298838·Laparoscopic Needle Holder Self-Righting Needle...
ELMED
FDA UDI
ELMED INCORPORATED·00842180167230·NEEDLE HOLDER, OPEN SELF-RIGHTINH TIP, LIGHTWEI...
Non-contact Electronic Forehead Infrared Thermometer
FDA 510(k)
FDA Class 2
·General Hospital
LOQTEQ Proximal Humerus Plate 3.5 System
FDA 510(k)
FDA Class 2
·Orthopedic
U-BLADE SET, TI GAMMA3 10.5X90MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·December 14, 2012
PRISM HBSAG
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code KSJ·November 14, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·September 14, 2011
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 29, 2013
Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is a sterile, single-patient-use device designed to provide assistance in childbirth under the following conditions: 1) Term pregnancy, 2) Ruptured amniotic membranes, 3) Engaged head, 4) Complete cervical dilation, and 5) Adequately trained or supervised operator.
FDA Enforcement
Class II
·Ongoing·Clinical Innovations, LLC·May 6, 2026
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012