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ABMC Receives FDA Clearance of Its Rapid TOX Cup®
KINDERHOOK, N.Y. -- American Bio Medica Corporation (NASDAQ:ABMC) announced today that the US Food and Drug Administration FDA has granted the Company 510k clearance on its Rapid TOX Cup, a patent pending drug screen in an all-inclusive cup platform. The clearance allows ABMC to provide the Rapid TOX Cup to...
Tags: clearance, FDA
Research articles 2008-06-03
Cook Medical Receives FDA 510 Clearance for Celect™ Vena Cava Filter and Gunther Tulip™ Vena Cava Filter Retrieval Set
Clearance Provides More Options for Prevention of Recurrent Pulmonary Embolism
Tags: clearance, FDA
Research articles 2008-03-19
Pyng Medical Receives US FDA Clearance
Pyng Medical Corp. (TSX VENTURE: PYT) today announced the Company has received Special 510K regulatory clearance from the US Food and Drug Administration to market its new and improved version of the award-winning FAST1TM Intraosseous IO Infusion System throughout the US, effective immediately.
Tags: clearance, FDA
Research articles 2008-02-19
Pyng Medical Receives US FDA Clearance; Enhanced FAST1(TM) Intraosseous Infusion System Now Available in the US.
VANCOUVER, BRITISH COLUMBIA, Feb 19, 2008 Marketwire via COMTEX -- Pyng Medical Corp. (TSX VENTURE:PYT) today announced the Company has received Special 510K regulatory clearance from the US Food and Drug Administration to market its new and impr VANCOUVER, BRITISH COLUMBIA, Feb 19, 2008 (Marketwire via...
Tags: clearance, FDA
Research articles 2008-02-19
Spinal Elements, Inc. Receives FDA 510 Market Clearance for its Lucent® Spinal Implants as a Lumbar Intervertebral Body Fusion Device
CARLSBAD, Calif. -- Spinal Elements, Inc. announced today the receipt of FDA 510k clearance to market the Lucent[R] Spinal Implants as lumbar intervertebral body fusion devices IBFD. This clearance of the Lucent system enables surgeons to utilize this advanced implant and instrumentation technology for degenerative disc disease and other common...
Tags: clearance, FDA, Lucent Technologies Inc.
Research articles 2007-11-20
Medcool Inc. Receives FDA Clearance for Its RapidCool (TM) System
Medcool Inc. of Wellesley, MA, an emerging provider of non-invasive systems for therapeutic hypothermia and temperature management, announced today that its RapidCoolTM System has received 510K clearance by the FDA to be marketed in U.S. for temperature reduction therapy.
Tags: clearance, FDA
Research articles 2007-07-30
The Chatsworth medical test company Iris International Inc. filed for Food and Drug Administration clearance for a more sensitive test for prostate cancer.(Briefly)
The Chatsworth medical test company Iris International Inc. filed for Food and Drug Administration clearance for a more sensitive test for prostate cancer. The company's Molecular Diagnostics units applied for the clearance for its ... The Chatsworth medical...
Tags: clearance, FDA
Research articles 2007-02-19
Software AG Receives Final Regulatory Clearance Needed for the Acquisition of webMethods, Inc
FAIRFAX, Va. -- webMethods, Inc. (Nasdaq:WEBM), a leading business integration and optimization software company, today announced that Software AG (TecDAX, ISIN DE 0003304002 / SOW) has received clearance from the Committee on Foreign Investment in the United States CFIUS for its proposed acquisition of webMethods. This was the final regulatory...
Tags: acquisition, clearance, Software AG, webMethods Inc.
Research articles 2007-05-24
Statoil and Hydro received clearance from the European Commission for the merger between Norsk Hydro ASA's petroleum activities and Statoil ASA
Statoil and Hydro received clearance from the European Commission for the merger between Norsk Hydro ASA's petroleum activities and Statoil ASA. The clearance represents a major step forward in completing the planned merger. However, merger clearances are still in the process of being obtained in other jurisdictions as required by...
Tags: clearance, European Commission, merger, petroleum
Research articles 2007-06-01
Stay Clear with the Right Gear.(Employee Safety.)
By Craig Firl, Project Manager, DBI-SALA and PROTECTA Here's How to Calculate Accurate Fall Distances and Clearances for Fall Arrest Systems Anytime an employee works on a structure where he or she could fall more than...
Tags: Clear, clearance, worker
Research articles 2006-04-01
OrthoHelix™ Surgical Designs, Inc. Receives Clearance From FDA for Distal Radius Plate
AKRON, Ohio -- OrthoHelix Surgical Designs, Inc. received clearance from the Food and Drug Administration on the DRLockTM Volar Plate and Screw System.
Tags: clearance, FDA
Research articles 2006-03-15
Oculus Innovative Sciences Announces FDA 510K Clearance of Microcyn Technology
PETALUMA, Calif. -- Clearance Permits the Use of Super-Oxidized, Non-Toxic and pH-Neutral MicrocynTM Technology in Moistening, Lubricating and Debriding of Acute and Chronic Wounds
Tags: clearance, FDA
Research articles 2005-05-09
Kingfisher Healthcare (KFH) Receives FDA Clearance to Market KFH Energy in the USA And Raises EUR1 Million to Accelerate Market Penetration.
LEUVEN, Belgium, March 31 /PRNewswire/ -- Kingfisher Healthcare, a young healthcare company focused on improving patient quality of life, announced today that the U.S. Food and Drug Administration FDA has granted the company 510k clearance to LEUVEN, Belgium, March 31 /PRNewswire/ --...
Tags: clearance, FDA, health care
Research articles 2008-03-31
A coalition of contractor groups has endorsed proposed legislation that would change the way the Homeland Security Department grants security clearances.(Washington Insider)
The industry organization, the Security Clearance Reform Coalition, said DHS has a history of refusing to recognize clearances granted by other agencies. A provision in the Homeland Security Authorization Act, H.R. 5814, would consolidate the personn The industry organization, the Security Clearance Reform Coalition, said...
Tags: clearance, security, U.S. Department of Homeland Security
Research articles 2006-08-11
Alliance Medical Corporation Receives 510k Clearance for Diamond Drill Burs; First Reprocessor 510k Clearance Since SVS Conclusion
PHOENIX, Ariz. -- Alliance Medical Corporation Alliance, a leading reprocessor of single-use medical devices SUDs, today announced U.S. Food and Drug Administration FDA clearance of Alliance's reprocessed diamond bur drill bits. This marks the first 510k clearance by the FDA for a reprocessed device without the need for a supplemental...
Tags: clearance, FDA
Research articles 2004-12-13
Restorative Therapies, Inc., Receives FDA Clearance for RT300-S
Restorative Therapies, Inc., a designer and supplier of medical devices, today announces FDA clearance of its breakthrough medical device, the RT300-S, a functional electrical stimulation FES motorized cycle ergometer.
Tags: clearance, FDA
Research articles 2005-08-23
Anulex Technologies Receives FDA 510 Clearance for the Inclose™ Surgical Mesh System
MINNEAPOLIS -- Anulex Technologies, Inc. announced today that it has received FDA 510k clearance of its IncloseTM Surgical Mesh System.
Tags: clearance, FDA
Research articles 2005-08-22
MedicalCV Receives Third FDA 510 Clearance for Laser Technology; Company Advances Its Leadership Position in Laser Technology for a Stand-Alone, Closed-Chest, Minimally Invasive Solution for Treating Atrial Fibrillation
MINNEAPOLIS -- MedicalCV, Inc. (OTCBB:MDCV), www.medcvinc.com, announced today that it has received its third 510k clearance from the U.S. Food and Drug Administration FDA which states that, "The MedicalCV AtrilazeTM Surgical Ablation system is indicated for delivery of 810nm or 1064nm laser light to soft tissue to include cardiac tissue...
Tags: clearance, FDA, laser, leadership
Research articles 2006-04-18
Kerberos Rinspiration System Receives Additional FDA Clearance
MOUNTAIN VIEW, Calif. -- Kerberos Proximal Solutions Inc. has received clearance from the U.S. Food and Drug Administration for coronary and peripheral use of the Rinspiration SystemTM. "Rinspiration" is focal simultaneous rinsing and aspiration administered by a single catheter. This clearance accelerates Kerberos' ability to support physician interest in the...
Tags: clearance, FDA
Research articles 2004-09-10
ZOLL Receives Marketing Clearance for E Series with Real CPR Help Technology
CHELMSFORD, Mass. -- ZOLL Medical Corporation (NASDAQ: ZOLL), a manufacturer of resuscitation devices and related software solutions, today announced that it received clearance from the U.S. Food and Drug Administration FDA to market and sell the ZOLL E Series[R] with Real CPR Help[TM] technology. ZOLL's Real CPR Help allows rescuers...
Tags: clearance, marketing
Research articles 2007-01-18
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