FDA Approvals
What the agency has cleared for sale. A new drug approval is the event a pharmaceutical company's whole pipeline exists to reach; a 510(k) clearance is a device shown to be equivalent to one already on the market. They are listed separately because they are not the same kind of news. Only original approvals are counted — a supplement is a label change, not a new medicine.
Most active applicants
In the recent window. Each has its own page.
Newest drug approvals
Original approvals only, newest first.
| Applicant | Product |
|---|---|
| Shandong | SUGAMMADEX SODIUMNew drugOct 6, 2026SOLUTION, INTRAVENOUS |
| Piramal Critical | DESFLURANENew drugOct 5, 2026LIQUID, INHALATION |
| Aurobindo Pharma Ltd | PERAMPANELNew drugOct 2, 2026TABLET, ORAL |
| Ever Valinject | NDA219617New drugOct 1, 2026 |
| Taro | LOPERAMIDE HYDROCHLORIDENew drugSep 30, 2026CAPSULE, ORAL |
| Gland | LEVOCARNITINENew drugSep 30, 2026INJECTABLE, INJECTION |
| Lupin | PHYTONADIONENew drugSep 30, 2026INJECTABLE, INJECTION |
| Zydus Lifesciences | MUPIROCIN CALCIUMNew drugSep 29, 2026CREAM, TOPICAL |
| Nephron | DEXMEDETOMIDINE HYDROCHLORIDENew drugSep 28, 2026INJECTABLE, INJECTION |
| Upsher Smith Labs | PREDNISOLONE ACETATENew drugSep 28, 2026SUSPENSION/DROPS, OPHTHALMIC |
| Rare Thyroid Therapeutics International Ab | EMCITATENew drugSep 28, 2026TABLET, ORAL |
| Novitium Pharma | ESOMEPRAZOLE MAGNESIUMNew drugSep 25, 2026FOR SUSPENSION, DELAYED RELEASE, ORAL |
| Steriscience | NAFCILLIN SODIUMNew drugSep 25, 2026INJECTABLE, INJECTION |
| Abbvie IncABBV | JUVMONew drugSep 25, 2026TABLET, ORAL |
| Hong KongHKXCY | THIAMINE HYDROCHLORIDENew drugSep 25, 2026INJECTABLE, INJECTION |
| Incyte CorpINCY | ATEBRIOZNew drugSep 25, 2026TABLET, ORAL |
| Teva Pharmaceuticals, Inc. | DEGEVMANew drugSep 25, 2026INJECTABLE, SUBCUTANEOUS |
| Adventapharma Dwc LLC | ZUEINONew drugSep 25, 2026INJECTABLE, INTRAVENOUS |
| Yichang Humanwell | DILTIAZEM HYDROCHLORIDENew drugSep 25, 2026TABLET, ORAL |
| Azurity Pharmaceuticals Inc | NDA221109New drugSep 25, 2026 |
| Adaptis | KETOROLAC TROMETHAMINENew drugSep 25, 2026INJECTABLE, INJECTION |
| Aurobindo Pharma Ltd | METRONIDAZOLENew drugSep 25, 2026GEL, VAGINAL |
| Nephron | PHENYLEPHRINE HYDROCHLORIDENew drugSep 24, 2026SOLUTION, INTRAVENOUS |
| Macleods Pharms | CRISABOROLENew drugSep 24, 2026OINTMENT, TOPICAL |
| Actavis Labs Fl | LINACLOTIDENew drugSep 24, 2026CAPSULE, ORAL |
| Elevar Therapeutics Inc | LYRFIGTUNew drugSep 23, 2026CAPSULE, ORAL |
| Zydus Pharms | MEXILETINE HYDROCHLORIDENew drugSep 23, 2026CAPSULE, ORAL |
| Eli Lilly And CoLLY | ONSWIKNew drugSep 23, 2026INJECTABLE, SUBCUTANEOUS |
| Shandong | KETOROLAC TROMETHAMINENew drugSep 23, 2026INJECTABLE, INJECTION |
| Annora Pharma | NORGESTIMATE AND ETHINYL ESTRADIOLNew drugSep 23, 2026TABLET, ORAL-28 |
| Senores Pharms | HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDENew drugSep 22, 2026TABLET, ORAL |
| Invagen Pharms | EMPAGLIFLOZINNew drugSep 22, 2026TABLET, ORAL |
| Ipca Labs Ltd | AMLODIPINE BESYLATENew drugSep 22, 2026TABLET, ORAL |
| Agl Welding Supply Co Inc Dba Agl Gas Technologies | CARBON DIOXIDE, USPNew drugSep 22, 2026GAS, INHALATION |
| Novitium Pharma | EVEROLIMUSNew drugSep 21, 2026TABLET, FOR SUSPENSION, ORAL |
| Lantheus MedicalLNTH | BRAVNETSANew drugSep 21, 2026SOLUTION, INTRAVENOUS |
| Amneal | LANREOTIDE ACETATENew drugSep 18, 2026SOLUTION, SUBCUTANEOUS |
| Hikma | DEFLAZACORTNew drugSep 18, 2026TABLET, ORAL |
| Baxter Hlthcare Corp | ROCURONIUM BROMIDENew drugSep 18, 2026INJECTABLE, INJECTION |
| Cipla | CALCIUM GLUCONATE IN SODIUM CHLORIDENew drugSep 17, 2026SOLUTION, INTRAVENOUS |
| Aurobindo Pharma Ltd | CYCLOSPORINENew drugSep 17, 2026CAPSULE, ORAL |
| Difgen Pharms | EPINEPHRINENew drugSep 15, 2026SOLUTION, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
| Macleods Pharms | MILNACIPRAN HYDROCHLORIDENew drugSep 15, 2026TABLET, ORAL |
| Strides Pharma | MILNACIPRAN HYDROCHLORIDENew drugSep 15, 2026TABLET, ORAL |
| Zydus Lifesciences | TRETINOINNew drugSep 15, 2026CREAM, TOPICAL |
| Zydus Pharms | EPINEPHRINENew drugSep 14, 2026SOLUTION, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
| Curium | BEXLUTRYNew drugSep 14, 2026INJECTABLE, INJECTION |
| Aurolife Pharma LLC | BECLOMETHASONE DIPROPIONATENew drugSep 14, 2026AEROSOL, METERED, INHALATION |
| Zydus Lifesciences | LETROZOLENew drugSep 14, 2026TABLET, ORAL |
| Ajanta Pharma Ltd | HALOPERIDOLNew drugSep 14, 2026TABLET, ORAL |
| Telix Pharmaceuticals Us Inc | PIXCLARANew drugSep 11, 2026INJECTABLE, INTRAVENOUS |
| Msn | DASATINIBNew drugSep 11, 2026TABLET, ORAL |
| Baxter Hlthcare Corp | METOCLOPRAMIDE HYDROCHLORIDENew drugSep 11, 2026INJECTABLE, INJECTION |
| Scholar Rock Inc | ISEMBYLDNew drugSep 11, 2026INJECTABLE, INJECTION |
| Rubicon Research | SPIRONOLACTONE AND HYDROCHLOROTHIAZIDENew drugSep 10, 2026TABLET, ORAL |
| Aurobindo Pharma Ltd | ISOTRETINOINNew drugSep 10, 2026CAPSULE, ORAL |
| Zhejiang Jutai Pharm | BRIVARACETAMNew drugSep 8, 2026TABLET, ORAL |
| Hetero Labs Ltd V | IBRUTINIBNew drugSep 8, 2026CAPSULE, ORAL |
| Micro Labs | TOPIRAMATENew drugSep 4, 2026CAPSULE, EXTENDED RELEASE, ORAL |
| Astrazeneca Pharmaceuticals, LPAZN | ETCAMAHNew drugSep 4, 2026TABLET, FILM COATED |
Newest device clearances
510(k) clearances, newest first.
| Applicant | Product |
|---|---|
| Fit-Pro KFT (Ltd.) - DBA E-Fit | Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension Kit 1 (UL-800-Shape-Ext-Kit-1);Ultimate Shape Extension Kit 2 (UL-800-Shape-Ext-Kit-2)510(k)Sep 27, 2026 |
| Rivarp Medical Pvt., Ltd. | Kentrospine Viktr-MIS® Pedicle screw system510(k)Sep 27, 2026Orthopedic |
| Align Technology, Inc.ALGN | Invisalign System510(k)Sep 25, 2026Dental |
| Cepheid | Xpert Respiratory Panel510(k)Sep 25, 2026Microbiology |
| Tempus AI, Inc.TEM | Tempus ECG-MR510(k)Sep 25, 2026Cardiovascular |
| SimBioSys, Inc. | TumorSight Risk510(k)Sep 25, 2026Pathology |
| CMT Health PTE., Ltd. | Profoject LOR Syringe510(k)Sep 25, 2026Anesthesiology |
| Spident Co., Ltd. | EsTemp Implant510(k)Sep 25, 2026Dental |
| Respironics, Inc. | Altis Full Face Mask510(k)Sep 25, 2026Anesthesiology |
| Hyundai Bioland Co., Ltd. | REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)510(k)Sep 25, 2026Dental |
| Aevice Health Pte. , Ltd. | Aevice Wheeze Detection Module510(k)Sep 25, 2026Anesthesiology |
| Arthrex, Inc. | Arthrex Beaming System510(k)Sep 25, 2026Orthopedic |
| Philips Ultrasound, LLC | EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System510(k)Sep 25, 2026Radiology |
| Solventum US, LLCSOLV | 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)510(k)Sep 25, 2026General Hospital |
| Wellysis Corp. | S-Patch CardioAI510(k)Sep 25, 2026Cardiovascular |
| Samsung Medison Co., Ltd. | EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound System510(k)Sep 25, 2026Radiology |
| Karl Storz SE & CO. KG | UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10)510(k)Sep 25, 2026Obstetrics/Gynecology |
| Life Detection Technologies | DistaSense(TM) (v1)510(k)Sep 25, 2026Cardiovascular |
| Ezisurg Medical Co., Ltd. | easyEndo E-Lite Single Use Powered Endoscopic Staplers; easyEndo E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo E-Lite Single Use Cartridges510(k)Sep 25, 2026General, Plastic Surgery |
| CapsoVision, Inc. | CapsoView (CVV); CapsoCloud (CLD)510(k)Sep 25, 2026Gastroenterology, Urology |
| Siemens Medical Solutions USA, Inc. | syngo.CT Brain Quantification510(k)Sep 25, 2026Radiology |
| Cyden Limited | Braun Aura 9 (6042)510(k)Sep 25, 2026General, Plastic Surgery |
| CMT Health PTE., Ltd. | Profoject Safety Sliding Blood Collection Set510(k)Sep 25, 2026Clinical Chemistry |
| MEDA Co., Ltd. | MD-6000S Bladder Scanner510(k)Sep 24, 2026Radiology |
| QIAGEN GmbH | QIAstat-Dx BCID GN Plus AMR Panel510(k)Sep 24, 2026Microbiology |
| Karl Storz SE & CO. KG | KARL STORZ SUPRALOOP510(k)Sep 24, 2026Obstetrics/Gynecology |
| Den-Mat Holdings, LLC | MPa Max adhesive510(k)Sep 24, 2026Dental |
| Diagnostica Stago, Inc. | STA® - Liquid Anti-Xa510(k)Sep 24, 2026Hematology |
| CNSAC Medshop GmbH | Disposable Belts for Polysomnography (CNSAC)510(k)Sep 24, 2026Anesthesiology |
| Shenzhen Nuon Medical Equipment Co., Ltd. | Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)510(k)Sep 24, 2026Physical Medicine |
| CIVCO Medical Instruments Co., Inc. | Align® Cover and Pad Guidance Tool510(k)Sep 24, 2026Radiology |
| OrthoPediatrics Corp. | Pediatric Nailing Platform Femur510(k)Sep 24, 2026Orthopedic |
| Anhui Jbh Medical Apparatus Co., Ltd. | Electric Scooter (FNS01,FNS03)510(k)Sep 24, 2026Physical Medicine |
| Carlsmed, Inc. | corra® cervical plating system510(k)Sep 24, 2026Orthopedic |
| Arthrex, Inc. | Arthrex Spine Compression FT Screw510(k)Sep 24, 2026 |
| BLUECORE COMPANY Co., Ltd. | PicoreMax (PicoreMax)510(k)Sep 24, 2026General, Plastic Surgery |
| inomed Medizintechnik GmbH | ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress510(k)Sep 24, 2026Neurology |
| Zimmer, Inc. | OsseoFit Stemless Shoulder System510(k)Sep 24, 2026Orthopedic |
| SETAGAYA SEIKI Co., Ltd. | DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece510(k)Sep 23, 2026Dental |
| Unidental Co., Ltd. | Cemented Plus Abutment510(k)Sep 23, 2026Dental |
| ProNova Solutions | VIRTUE QA510(k)Sep 23, 2026Radiology |
| Zimmer BiometZBH | G7® Acetabular System510(k)Sep 23, 2026Orthopedic |
| Special Situations, LLC | Everslide510(k)Sep 23, 2026Obstetrics/Gynecology |
| Guangdong Ashmore Health Technology Co., Ltd. | Hair Growth Comb (X-GC01)510(k)Sep 23, 2026Physical Medicine |
| MedShape, Inc. | DynaNail Helix® Fixation System510(k)Sep 23, 2026Orthopedic |
| Costa Surgical, Inc. | ProRib Fixation System510(k)Sep 23, 2026Orthopedic |
| Oxytek Medical Technology Co., Ltd. | Portable Oxygen Concentrator (OX-1A-E, OX-1B)510(k)Sep 23, 2026Anesthesiology |
| Suzhou Green Pine Medical Co., Ltd. | Electric wheelchair (GP100)510(k)Sep 23, 2026Physical Medicine |
| SI-BONE, Inc. | iFuse Granite Onyx Implant System510(k)Sep 23, 2026Orthopedic |
| BTL Industries, Inc. | BTL-299-F510(k)Sep 23, 2026Gastroenterology, Urology |
| Teleflex MedicalTFX | Liquick X-treme, Liquick X-treme Plus510(k)Sep 23, 2026Gastroenterology, Urology |
| Hunan Vathin Medical Instrument Co., Ltd. | Single-use Flexible Bronchoscope510(k)Sep 23, 2026Ear, Nose, Throat |
| Elevation Spine | SABER-C System510(k)Sep 23, 2026Orthopedic |
| Abbott LaboratoriesABT | Anti-HCV Next510(k)Sep 23, 2026Microbiology |
| Syneris | Syneris PACS v.1.0.1.0510(k)Sep 23, 2026Radiology |
| Alfa Scientific Designs, Inc. | Instant-View® hCG Combo II Cassette Test510(k)Sep 22, 2026Clinical Chemistry |
| ACTO GmbH | Actolind® (06.3637. Actolind® Gel Plus)510(k)Sep 22, 2026 |
| Biofire Diagnostics | BIOFIRE Respiratory Panel 2.1 (RP2.1)510(k)Sep 22, 2026Microbiology |
| Strongback Mobility AG C/O Blueaudit GmbH | ErgoSteel (ES0001/696)510(k)Sep 22, 2026Physical Medicine |
| Visiana | BoneXpert510(k)Sep 22, 2026Radiology |