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*  Title 21 of the Code of Federal Regulations
Food and Drug Administration (2008). "Subchapter H - Medical Devices: Part 814 Premarket Approval of Medical Devices". ... 803 Medical Device Reporting 814 Premarket Approval of Medical Devices 820 et seq. Quality system regulations (analogous to ... The 1000 series covers radiation-emitting device (e.g. cell phones, lasers, x-ray generators); requirements enforced by the ... Listing of specific approved devices and how they are classified The 900 series covers mammography quality requirements ...
*  List of WLAN channels
"443999 D01 Approval of DFS UNII Devices v01r04". apps.fcc.gov. Retrieved 14 August 2015. "RSS-247 - Digital Transmission ... Few devices, however, have a method to enable a lower powered channel 12.[citation needed] ^C Channel 14 is valid only for DSSS ... Devices must be professionally installed when operating in the 5470 - 5725 GHz band FCC Office of Engineering and Technology. " ... Per recent FCC Order 16-181, "an authorized access point device can only operate in the 2483.5-2495 MHz band when it is ...
*  Office of In Vitro Diagnostics and Radiological Health
Class 3 devices require a "Pre-market Approval" (PMA), which is analogous to the drug approval process with clinical trials and ... "Medical Device Recalls: Comment on 'Medical Device Recalls and the FDA Approval Process.'" Arch Intern Med. 2011; 0: 2011271-2 ... "Medical Device Recalls and the FDA Approval Process." Arch Intern Med. 2011; 0: 2011301-6. PMID 21321283 Redberg and Dhruva. " ... A Class 2 device is required to be "substantially equivalent" to existing devices. The class is now used for "medium risk" ...
*  Abiomed
Since 2005, Impella heart devices have received a series of FDA approvals. In 2007, the Impella 2.5 heart pump was among 35 ... Altman, Lawrence K. (2006-09-06). "Implantable Heart Device Receives F.D.A. Approval". The New York Times. ISSN 0362-4331. ... Altman, Lawrence K. (2006-09-06). "Implantable Heart Device Receives F.D.A. Approval". The New York Times. ISSN 0362-4331. ... The AbioCor won FDA approval in 2006 for patients who are near death and do not qualify for a heart transplant. In 2004, ...
*  Implant failure
Zuckerman, Diana (2011). "Medical Device Recalls and the FDA Approval Process". Archives of Internal Medicine. 171: 1006-11. ... In a few cases the devices had been deemed so low-risk that they did not need FDA regulation. Of the 113 devices recalled, 35 ... When such symptoms occur, the patient's clinical team evaluates the patient and the device using in-situ methods, and ... The most commonly reported device failures are due to impacts, loss of hermeticity, and electrode lead malfunctions. Most ...
*  Prevention of migraines
... this was the first medical device to get FDA approval for this purpose. Neurostimulation initially used implantable ... A transcutaneous electrical nerve stimulation device called Cefaly was approved by the Food and Drug Administration in the ...
*  OrthoCor
The PEMF is activated when single-use OrthoPods are inserted into the device. The OrthoCor Active System was a featured product ... following approval from the FDA. The OrthoCor Active System is indicated for adjunctive use in the palliative treatment of post ... is a privately owned medical device company based in Arden Hills, Minnesota. Founded in 2007, OrthoCor develops drug-free, ... The Active System was introduced as a cutting edge device among other health care technologies. "OrthoCor Medical Official Home ...
*  Vagus nerve stimulation
In 1997, the US Food and Drug Administration's neurological devices panel met to consider approval of a vagus nerve stimulator ... "Investigation raises concerns about the post-approval surveillance of medical devices". ScienceDaily. November 4, 2010. ... The device consists of a generator the size of a matchbox that is implanted under the skin below the patient's clavicle. Lead ... VNS devices are used to treat drug-resistant epilepsy and treatment-resistant major depressive disorder (TR-MDD). As of 2017 ...
*  Syneron Medical
"Radiofrequency device for skin treatment wins FDA approval". Aesthetic Medical News. CNNMoney.com. 8 October 2008. Retrieved 22 ... LipoLite is a device that uses a Nd:YAG laser to vaporize fat -- a form of laser surgery. Matrix RF - radiofrequency device for ... Its product line includes devices for hair removal, wrinkle treatment, and skin rejuvenation. Shares of Syneron are traded on ... "Syneron and Candela - the New Face of Cosmetics". Medical Device Network. 16 October 2009. Retrieved 22 October 2011. "Moshe ...
*  Cryolipolysis
In September 2000, Zeltiq received EU CE Mark approval for their cryolipolysis device.[citation needed] In June 2012, the US ... Mark N. Melkeson (2 May 2012). "Contact cooling system for aesthetic use" (PDF). Division of Surgical Devices, US Food and Drug ... "The Skinny on fat reduction, cellulite devices". dermatologytimes.modernmedicine.com/. Dermatology Times. Retrieved 3 January ... Food and Drug Administration approved the cryolipolysis device for interstate commerce. Coleman, S, Sachdeva, K, Egbert, B, ...
*  Bump fire
This reversal was made due to a difference in the device submitted for approval and the device issued for sale. An additional ... Devices may be employed to aid in "bumping". However, not all such devices or modifications are legal. A famous example in the ... "Bump stock: The device found on Las Vegas shooter's guns". CNN. Retrieved 2017-10-06. "The "bump stocks" used in the Las Vegas ... In the 2017 Las Vegas shooting, twelve bump fire stock devices were found at the scene. The National Rifle Association stated ...
*  Ventricular assist device
The device has obtained CE Mark in Europe, and FDA approval in the U.S. Recently, it was shown that the Heartware HVAD can be ... One device gained CE Mark approval for use in the EU and began clinical trials in the US (VentrAssist). As of June 2007 these ... As a result of the clinical outcomes, the device received FDA approval for both indications, in 2001 and 2003, respectively. ... Aug 2009). "Initial FDA Post-Approval Study INTERMACS Registry Results with a Continuous Flow Left Ventricular Assist Device as ...
*  Avery Biomedical Devices
The device received full pre-market approval from the FDA in 1987, and is the only such device with this approval. A similar ... Avery Biomedical Devices is a biomedical engineering and device company that invented and distributes the Mark IV Breathing ... The device is placed as an alternative to the traditional ventilator in patients with quadriplegia, central sleep apnea, ... "Premarket Approval (PMA)" http://www.averybiomedical.com/ Phrenic nerve pacing Khong, Peter; Lazzaro, Amanda; Mobbs, Ralph ( ...
*  CONRAD (organization)
CONTRACEPTION: CONRAD conducted studies leading to the regulatory approval of several contraceptive devices. CONRAD supported ... Other contraceptive devices include Lea's Shield barrier device, and the FemCap barrier device [2]. CONRAD was a collaborator ... Two subsequent trials tested the gel in larger populations in order to provide more evidence for regulatory approval: VOICE, ...
*  Five-O (mobile application)
The application is available for download on Android devices and is pending approval from iStore. Elahe Izadi blogging for The ...
*  National Center for Health Research
"JAMA Network - JAMA Internal Medicine - Medical Device Recalls and the FDA Approval Process". American Medical Association. 13 ... "JAMA Network - JAMA Internal Medicine - Medical Device Recalls: Get It Right the First Time: Comment on "Medical Device Recalls ... determined that most of the devices that were high-risk recalls had never been studied in clinical trials prior to FDA approval ... June 2015). "More data are needed for Essure hysteroscopic sterilization device". Contraception.2015; 91(6):520. doi: 10.1016/j ...
*  Good Technology
Good software was required in the U.S. Department of Defense's first approval of Android devices in 2012. In 2013, the platform ... The company focuses on securing apps and data on mobile devices. Good Technology in its current form is a continuation of two ... Gallant, John (August 12, 2013). "Good Technology CEO: "We focus on the data, not the device"". CITE World. Visto profile on ... Prior to the acquisition, both companies were known as market leaders in email access from portable devices. In November 2006, ...
*  Contraceptive implant
Play media Play media Several options exist for women, depending on the approval status of devices in their region. The ... An intrauterine device (IUD) is a small contraceptive device, often 'T'-shaped and containing either copper or the hormone ... Shepherd Medical Company received FDA approval for a clinical trial of its non-hormonal implant called an intra vas device (IVD ... Several implantable devices have been attempted, both hormonal and non-hormonal. In 2001, Dutch pharmaceutical company Organon ...
*  Type Allocation Code
The Type Approval Code (also known as TAC) indicated that the particular device was approved by a national GSM approval body ... instead of submitting a device for approval to a national review body. Both the old and new TAC uniquely identify a model of ... moved away from requiring that devices be approved by national bodies, and towards a system where device manufacturers self- ... Prior to January 1, 2003, the global standard for the IMEI started with a six-digit Type Approval Code followed by a two-digit ...
*  Cartridges and canisters of air-purifying respirators
US NIOSH occupational safety and health standard 42 Code of Federal Register 84 Approval of Respiratory Protective Devices '' ... ISBN 0-471-01280-7. 42 Code of Federal Register 84 Approval of respiratory protective devices §84.113 - Canisters and ... If the cartridges have a device that warns of an employee of the approaching expiration of the term of service life (End of ... Respiratory protective devices. Gas filters and combined filters. General specifications (on Russian) RF state standard ГОСТ Р ...
*  Tinnitus masker
Sound generators (masking devices) have received Class II approval from the FDA. However, they are considered to be " ... or combination devices that mix both functions into one device. A standard hearing aid may be used for tinnitus masking; the ... A commercial device based on the phenomenon (Aurex3) was approved by the FDA. A new development in tinnitus management is the ... These masker devices use soothing natural sounds such as ocean surf, rainfall or synthetic sounds such as white noise, pink ...
*  Authorization certificate
... signs the software with the private key of the PKC and sends the signed software to the device manufacturer for approval. After ... When the software is put into the computing device, the device will verify the integrity of the software using the developer's ... device employing DRM like iPad where software can only be run in the device after the software has been approved by the device ... the software the basic capability to install itself and be executed as well as an additional capability to use the Wi-Fi device ...
*  Morgridge Institute for Research
... work focuses on translational research including better ways to move potential new medical devices through regulatory approval ... Thomas "Rock" Mackie, director of medical devices, is a UW-Madison professor of medical physics and human oncology at the ... Research in regenerative biology, virology, medical devices and core computational technology is currently underway. The ... and medical devices. These challenge areas build on core research strengths at UW-Madison and are supported by the university's ...
*  MagForce AG
It has receive European regulatory approval for a nanoparticle-based medical device. The company was founded in 1997 as a spin- ... In the U.S., MagForce is expecting to launch a pre-approval study for the treatment of prostate cancer and in Europe it is ... In: Medical Device Daily. 29. August 2014. Christian Euler. "Was machen die Geschäfte ... Herr Lipps? „Das Leben vieler ... Furthermore, the company is now using its devices in clinics and launched a post-marketing clinical study that has since been ...
*  Cameron Health
... and resulted in approval for marketing the device. A study of 300 patients is in progress for US approvals. Small nonrandomized ... Some device manufacturers have had to replace defective leads which exposed implanted individuals to unnecessary shocks or ... ICDs with transvenous leads administer this shock to the interior of the heart muscle; the Cameron Health device generated a ... In the view of Cameron Health, transvenous leads into the heart needlessly complicated the process of implanting a device, and ...
*  Rafael Beyar
Following government approval, construction is scheduled to begin shortly on a new Biomedical Discovery Tower which will host ... Rae Fishmann, Medical Device Daily Israel Correspondent (August 8, 2007). "Report from Israel". Contact Center Solutions ...