Accessdata.fda.gov

Microsoft Advertising Formerly Bing Ads

Do you own accessdata.fda.gov? You're Missing Out on High Value Audience with Lower Cost-per-Click & Great ROI! Get Started Today.

Actived: 7 days ago

URL: go.microsoft.com

[email protected]: FDA-Approved Drugs

U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 1-888-INFO-FDA (1-888-463-6332) Contact FDA

Category:  Food Go Health

[email protected]: FDA-Approved Drugs

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 05/23/2022: ORIG-1: Approval Label (PDF)

Category:  Health Go Health

510(k) Premarket Notification

1 to 10 of 36 Results ProductCode: LLZ Applicant: GE HEALTHCARE Decision Date To: 05/24/2022 1

Category:  Health Go Health

510(k) Premarket Notification

3M HEALTH CARE, SARNS K771499: 08/16/1977 sarns mediastinal and pericardial tube: 3M HEALTH CARE, SARNS K792070: 11/21/1979 sarns wire-reinforced venous return can: 3M HEALTH CARE, SARNS K790246: 03/02/1979 sarns two-state wire reinforced catheter

Category:  Health Go Health

Premarket Approval (PMA)

misago rx self-expanding peripheral stent system: TERUMO MEDICAL CORPORATION: P140002 S021: 06/09/2021: misago rx self-expanding peripheral stent system

Category:  Medical Go Health

Premarket Approval (PMA)

angelmed guardian system: ANGEL MEDICAL SYSTEMS INC. P150009 S007: 05/19/2022: liaison® xl murex hbeag assay and control: DiaSorin Inc. P180048 S007: 05/05/2022

Category:  Medical Go Health

Premarket Approval (PMA)

foundationone liquid cdx (f1 liquid cdx) Foundation Medicine Inc. P190032 : 08/26/2020: cobas? hiv-1/hiv-2 qualitative: Roche Molecular Systems, Inc. BP190360

Category:  Medicine Go Health

Premarket Approval (PMA)

edwards sapien transcatheter heart valve and acce: EDWARDS LIFESCIENCES, LLC. P100041 : 11/02/2011: edwards sapien transcatheter heart …

Category:  Health Go Health

Medical Device Recalls

10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA

Category:  Health Go Health

Premarket Approval (PMA)

advisa dr ipg, advisa dr mri ipg: MEDTRONIC Inc. P980035 S337: 07/30/2013: medtronic protecta xt/protecta/secura/maximo ii dr: MEDTRONIC CARDIAC RHYTHM DISEA

Category:  Health Go Health

Premarket Approval (PMA)

victory, zephyr, accent, assurity, assurity+, endu: Abbott Medical: P880086 S281: 03/30/2017: ventak av, ventak prizm dr/vr, vitality, confient, BOSTON SCIENTIFIC

Category:  Medical Go Health

Premarket Approval (PMA)

service kit-pacemaker repair kit,vitatron brillian: Medtronic, Inc. P890003 S337: 10/02/2015: restore, itrel, and synergy spinal cord stimulatio: MEDTRONIC NEUROMODULATION

Category:  Health Go Health

Premarket Approval (PMA)

lnterstim therapy system, verify evaluation system: MEDTRONIC NEUROMODULATION: P970004 S337: 08/13/2021: precision spinal cord stimulator (scs) systems

Category:  Health Go Health

OTC [email protected]

Status. Final Order. Summary. Over-the-Counter Monograph M014: Topical Otic Drug Products for Over-the-Counter Human Use is a final administrative order (final order) deemed by section 505G(b)(8) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355h(b)(8)), and effective upon enactment of the Coronavirus Aid, Relief, and …

Category:  Food,  Coronavirus Go Health

Premarket Approval (PMA)

current+, fortify, fortify assura, and ellipse icd: Abbott Medical: P910023 S337: 06/25/2014: promote+ cd3211-36, cd3211-36q; unify cd3231-40, c: Abbott Medical

Category:  Medical Go Health

Premarket Approval (PMA)

vns therapy system: LivaNova USA, Inc. P970003 S154: 02/01/2013: vitalio, formio: Boston Scientific Corp. N970003 S154: 08/22/2013: various families of icds

Category:  Health Go Health

Establishment Registration & Device Listing

Proprietary Name: Suture, Absorbable, Synthetic, Polyglycolic Acid - DeRoyal: Classification Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Category:  Health Go Health

Premarket Approval (PMA)

y adaptor/extender kit, is-1 connector port pin pl: MEDTRONIC Inc. P920015 S218: 10/18/2018: vns therapy sentiva model 1000 generator, vns ther: LivaNova USA, Inc.

Category:  Health Go Health

Premarket Approval (PMA)

foundationone liquid cdx (f1 liquid cdx) Foundation Medicine Inc. P190032 S001: 07/15/2021: guardant360 cdx: Guardant Health, Inc. P200010 S001: 05/21/2021

Category:  Medicine Go Health

Premarket Approval (PMA)

torque wrench: Abbott Medical: P010032 S154: 09/26/2019: allure quadra, quadra allure mp, frontier: Abbott Medical: P030035 S154: 10/20/2017: epic hf/atlas+ hf family of crt-ds

Category:  Medical Go Health

510(k) Premarket Notification

510 (k) Number. K213174. Device Name. Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection. Applicant. Cardinal Health. 3651 Birchwood Drive.

Category:  Health Go Health

Device Classification Under Section 513(f)(2)(De Novo)

Device Classification Under Section 513(f)(2)(De Novo) FDA Home; Medical Devices; Databases - 211 to 220 of 333 results Decision Date To: 05/24/2022

Category:  Medical Go Health

Premarket Approval (PMA)

revo mri ipg: Medtronic, Inc: P090013 S112: 02/14/2014: express2 coronary stent system: BOSTON SCIENTIFIC SCIMED, INC. P020009 S112: 12/20/2013: introduction cp900 series rechargeable batteries (

Category:  Health Go Health

Premarket Approval (PMA)

acs rx comet(tm) coronary dilation catheter: ADVANCED CARDIOVASCULAR SYSTEM: P810046 S166: 11/18/1996: activa depp brain stimulation activa pc, activa sc

Category:  Health Go Health

Premarket Approval (PMA)

gore viabahn endoprosthesis and endoprosthesis wit: W.L. GORE & ASSOCIATES,INC: P130006 S043: 10/10/2017: mentor memorygel silicone gel - filled breast impl

Category:  Health Go Health

Premarket Approval (PMA)

ventak av, ventak prizm dr/vr, vitality, confient, BOSTON SCIENTIFIC: P960040 S281: 12/05/2012: adapta, adapta l, adapta s, sensia l, sensia, vers: MEDTRONIC Inc.

Category:  Health Go Health

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health …

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center – WO66-G609 Silver Spring, MD 20993-0002 March 26, 2015 Ethicon Incorporated Ms. Susan Lin, RAC Manager, Regulatory Affairs P.O. Box 151 Route 22 West Somerville, New Jersey 08876 Re: K142822

Category:  Food Go Health

Mammography Facilities

Health Village Imaging (609) 660-9729 Manahawkin, NJ 08050 Health Village Imaging (732) 497-1200 Jackson, NJ 08527 Hillsborough Radiology Ce (908) 874-7600 x2746 Hillsborough, NJ 08844 Hirsch and Ratakonda, M.D (973) 538-8181 Morristown, NJ

Category:  Health Go Health

Mammography Facilities

Hackensack Meridian Health Palisades Medical Center: 7650 River Road Suite 240: North Bergen, NJ 07047 (201) 854-5014 fax: (201) 520-4798

Category:  Medical Go Health

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health …

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 NDA 20-415/S-015 Organon Inc. Attention: Albert P. Mayo Director, Regulatory Affairs 375 Mt. Pleasant Avenue …

Category:  Food Go Health