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Class II Special Controls Documents
… Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid System (TACHAS) - Guidance for Industry and FDA …
CDRHNew - News and Updates
Network of Experts- Expert Utilization Standard Operating Procedure (DRAFT)
… committee meeting also provides a forum for a public hearing on important matters. CDRH recognizes that advisory …
Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19
… Device Shortages List web page. The FDA is interested in hearing from health care facilities and other stakeholders …
Non-Invasive Body Contouring Technologies
… frequencies higher than the upper audible limit of human hearing. Ultrasound may be used therapeutically to treat …
Summary of the Medical Device User Fee and Modernization Act of 2002
… accreditation (following an opportunity for an informal hearing) if we find an accredited person is "substantially … our accreditation pending an opportunity for an informal hearing. Id. Not all establishments are eligible for …
January 2022 510(K) Clearances
… AVAILABLE FROM FDA DEVICE: BHA100 Series Braun Clear Hearing Aid Kaz USA, Inc., a Helen of Troy Com510(k) NO: … SUMMARY AVAILABLE FROM FDA DEVICE: Jabra Enhance Plus GN Hearing A/S 510(k) NO: K213424 (Traditional) ATTN: Lars …
Exemptions From Electronic Product Regulations
… and will also be given an opportunity for a regulatory hearing on the matter. Upon receiving the notice, the …
Recalls, Corrections and Removals (Devices)
… in the order will have an opportunity for a regulatory hearing or to provide a written request to FDA asking that …
Overview of Regulatory Requirements: Medical Devices - Transcript
… a cranial orthosis. There's special labeling for IVDs, for hearing aids, for condoms. So, very important to look to see …
CDRH Learn
… Program Presentation Printable Slides Transcript Hearing Aids and Personal Sound Amplification Products …
Withdrawn or Expired Guidance
… Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids - Guidance for Industry and Food and Drug …
August 2022 510(K) Clearances
… FROM FDA DEVICE: MDHearingAid app, MDHearingAid Smart hearing aids MDHearingAid 510(k) NO: K220303 (Traditional) … SUMMARY AVAILABLE FROM FDA DEVICE: Vibe SF Self-Fitting Hearing Aid WSAUD A/S 510(k) NO: K220403 (Traditional) ATTN: …
September 2023 510(K) Clearances
… 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Self-Fitting hearing aids Huizhou Jinghao Medical Technology510(k) NO: … 510(k) STATEMENT DEVICE: Intrisound™ Tuned Lumen® 155 Hearing Aids Tuned Ltd 510(k) NO: K223848 (Traditional) ATTN: …
June 2023 510(K) Clearances
… AVAILABLE FROM FDA DEVICE: All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid Sonova AG 510(k) NO: K230538 (Traditional) ATTN: …
October 2023 510(K) Clearances
… 0081 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sontro® OTC Hearing Aids (AI) Soundwave Hearing, LLC 510(k) NO: K231550(Traditional) ATTN: Anthony …
May 2021 510(K) Clearances
… SUMMARY AVAILABLE FROM FDA DEVICE: Bose SoundControl Hearing Aids Bose Corporation 510(k) NO: K211008(Special) …
March 2021 510(K) Clearances
… SUMMARY AVAILABLE FROM FDA DEVICE: Ponto Bone Anchored Hearing System, MONO Surgery Kit Oticon Medical AB 510(k) NO: …
May 2022 510(K) Clearances
… auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for …
October 2022 510(K) Clearances
… SUMMARY AVAILABLE FROM FDA DEVICE: Nuheara IQbuds 2 PRO Hearing Aid Nuheara Limited 510(k) NO: K221064 (Traditional) …
March 2023 510(K) Clearances
… AVAILABLE FROM FDA DEVICE: Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application hearX SA (Pty) Ltd. …
Medical Device User Fee and Modernization Act of 2002 (MDUFMA), P.L. 107-250
… after providing notice and an opportunity for an informal hearing, when such person is substantially not in compliance …