www.accessdata.fda.gov
- Domain
- www.accessdata.fda.gov
- Category
- Uncategorized
- Publisher
- fda.gov
Top References from www.accessdata.fda.gov
| Score | Article | Date | Citations |
|---|---|---|---|
| 2.7 |
De Novo Summary: De Novo Classification Request for Cerena Transcranial Magnetic Stimulator (TMS) Device (headache)https://www.accessdata.fda.gov/cdrh_docs/reviews/k130556.pdf |
N/A | 1 |
| 2.7 |
Drug Approval Package: Suprep Bowel Prep Kit (Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate) Oral Solutionhttps://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022372_suprep_toc.html |
N/A | 1 |
| 2.7 |
Establishment Registration & Device Listinghttps://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfRL/rl.cfm?rid=239250 |
N/A | 1 |
| 2.7 |
Letter: 510(k) Premarket Notification: Rapid2 Therapy Systemhttps://www.accessdata.fda.gov/cdrh_docs/pdf14/k143531.pdf |
N/A | 1 |
| 2.7 |
De Novo Summary (DEN170078): De Novo Classification Request for Brainsway Deep Transcranial Magnetic Stimulation Systemhttps://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170078.pdf |
N/A | 1 |
| 2.7 |
Establishment Registration & Device Listinghttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=411781&lpcd=KOB |
N/A | 1 |
| 2.7 |
510(k) Summary: Nexstim Navigational Brain Stimulation (NBS) System 4, and Nexstim NBS System 4 with NEXSPEECH®https://www.accessdata.fda.gov/cdrh_docs/pdf11/k112881.pdf |
N/A | 1 |
| 2.7 |
Device Classification Under Section 513(f)(2) (De Novo): OTTAVA Robotic Surgical Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250068 |
N/A | 1 |
| 2.7 |
Drugs@FDA: FDA-Approved Drugshttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm |
N/A | 1 |
| 2.7 |
Risk Evaluation and Mitigation Strategy (REMS) Document PALYNZIQ® (pegvaliase-pqpz) REMShttps://www.accessdata.fda.gov/drugsatfda_docs/rems/Palynziq_2023_12_09_REMS_Full.pdf |
N/A | 1 |
| 2.7 |
Drug Approval Package: Tindamax (Tinidazole) NDA #021618, 021681 & 021682https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-618_21-681_21-682_Tindamax.cfm |
N/A | 1 |
| 2.7 |
510(k) Premarket Notification: Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222171 |
N/A | 1 |
| 2.7 |
Product Classification: Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorderhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=4130 |
N/A | 1 |
| 2.7 |
510(k) Premarket Notificationhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221282 |
N/A | 1 |
| 2.7 |
510(k) Premarket Notificationhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252981 |
N/A | 1 |
| 2.7 |
EVAMIST (estradiol transdermal spray) prescribing informationhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022014s015lbl.pdf |
N/A | 1 |
| 2.7 |
Drug Approval Package: Bosulif (Bosutinib)https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203341_bosulif_toc.html |
N/A | 1 |
| 2.7 |
Iopidine: FDA-Approved Drugshttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019779 |
N/A | 1 |
| 2.7 |
Truvada approval packagehttps://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021752Orig1s030Approv.pdf |
N/A | 1 |
| 2.7 |
K213105 510(k) Epilady 2000’s Epilaser Absolute Premarket Notificationhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213105 |
N/A | 1 |
| 2.7 |
Drugs@FDA: FDA-Approved Drugshttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=065461#:~:text=Notes-,08/10/2009,-ORIG-1 |
N/A | 1 |
| 2.7 |
Establishment Registration & Device Listinghttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm?rid=19127 |
N/A | 1 |
| 2.7 |
NDA approval letterhttps://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219423Orig1s000ltr.pdf |
N/A | 1 |
| 2.7 |
Ontak (denileukin diftitox) Approval Letterhttps://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/denser020599L.htm |
N/A | 1 |
| 2.7 |
Import Alert 99-42https://www.accessdata.fda.gov/cms_ia/importalert_1167.html |
N/A | 1 |
| 2.7 |
Risk Evaluation and Mitigation Strategy (REMS) Document ZULRESSO (brexanolone) REMS Programhttps://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211371Orig1s000REMS.pdf |
N/A | 1 |
| 2.7 |
Viread Approvalhttps://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-356_Viread_Approv.pdf |
N/A | 1 |
| 2.7 |
Truvada Approvalhttps://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021752s000_Truvada_Approv.pdf |
N/A | 1 |
| 2.7 |
Mesomarkhttps://www.accessdata.fda.gov/cdrh_docs/pdf6/h060004c.pdf |
N/A | 1 |
| 2.7 |
Device Classification Under Section 513(f)(2)(De Novo): NeuroStar TMS Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?ID=DEN070003 |
N/A | 1 |
| 2.7 |
Drugs@FDA: FDA-Approved Drugshttps://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019839 |
N/A | 1 |
| 2.7 |
Approval Letter: Intuniv (guanfacine extended-release tablets)https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022037s000ltr.pdf |
N/A | 1 |
| 2.7 |
FDA Approval Letterhttps://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219428Orig1s000ltr.pdf |
N/A | 1 |
| 2.7 |
Product label: HIGHLIGHTS OF PRESCRIBING INFORMATIONhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020634s073lbl.pdf |
N/A | 1 |
| 2.7 |
Product Classification: Transcranial Magnetic Stimulatorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=4081 |
N/A | 1 |
| 2.7 |
TPLC - Total Product Life Cycle: Transcranial Magnetic Stimulatorhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/tplc.cfm?id=4081&min_report_year=2011 |
N/A | 1 |
| 2.7 |
510(k) Premarket Notification: Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigationhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211389 |
N/A | 1 |
| 2.7 |
Device Classification Under Section 513(f)(2)(De Novo)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN130022 |
N/A | 1 |
| 2.7 |
Establishment Registration & Device Listinghttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=72987&lpcd=FEN |
N/A | 1 |
| 2.7 |
Prescription labelhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210166s002lbl.pdf |
N/A | 1 |
| 2.7 |
Addyihttps://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022526s013lbl.pdf |
N/A | 1 |
| 2.7 |
510(k) Premarket Notification: Brainsway Deep TMS Systemhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=k122288 |
N/A | 1 |
| 2.7 |
Product Classification: Transcranial Magnetic Stimulator For The Treatment Of Migraine Headachehttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=4085 |
N/A | 1 |
| 2.7 |
510(k) Premarket Notificationhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240929 |
N/A | 1 |
| 2.7 |
Establishment Registration & Device Listinghttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=72985&lpcd=KGZ |
N/A | 1 |
| 2.7 |
Establishment Registration & Device Listinghttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=411783&lpcd=CCK |
N/A | 1 |
| 2.7 |
Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book): Kafocin (NDA 050219)https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl_No=050219#5564 |
N/A | 1 |
| 2.7 |
Establishment Registration & Device Listinghttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm |
N/A | 1 |
| 2.7 |
Prescribing Information for ZOFRAN TABLETS, ZOFRAN ODT, and ZOFRAN ORAL SOLUTIONhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020103s038,020605s022,020781s022lbl.pdf |
N/A | 1 |
| 2.7 |
Prozac (fluoxetine) Labelhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018936s091lbl.pdf |
N/A | 1 |