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calendar

21,216 catalysts · 16,398 approval · 3,085 device 510k · 664 device pma · 592 recall · 477 device recall

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  • approval16,398
  • device 510k3,085
  • device pma664
  • recall592
  • device recall477
therapy area

no tagged catalysts yet

Week of Nov 18, 2024

50
›Nov 20, 2024device 510k653d agoIndiba S. A. U. — INDIBA COMPACT devices (510k cleared)

Product code: PBX. Advisory committee: General, Plastic Surgery. Type: Traditional

full page →fda device 510k ↗
›Nov 20, 2024device 510k653d agoPro Surgical, Inc. — ProAM ACDF System (510k cleared)

Product code: OVE. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗
›Nov 20, 2024device 510k653d agoOsstem Implant Co., Ltd. — Estar-ZE (510k cleared)

Product code: EIH. Advisory committee: Dental. Type: Traditional

full page →fda device 510k ↗
›Nov 20, 2024device 510k653d agoExo, Inc. — Strain AI (SAI001) (510k cleared)

Product code: QIH. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗
›Nov 20, 2024device 510k653d agoShenzhen Ruiyi Business Technology Co., Ltd. — Leg Massager (Models:RP-ALM070H, RP-ALM071H) (510k cleared)

Product code: IRP. Advisory committee: Physical Medicine. Type: Traditional

full page →fda device 510k ↗
›Nov 20, 2024device 510k653d agoGostar Co., Ltd. — TD-7301 Spirometer (TD-7301) (510k cleared)

Product code: BZG. Advisory committee: Anesthesiology. Type: Traditional

full page →fda device 510k ↗
›Nov 20, 2024device 510k653d agoQ'Apel Medical, Inc. — Neurovascular Access System Family (510k cleared)

Product code: QJP. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗
›Nov 20, 2024device 510k653d agoShenzhen Kaiyan Medical Equipment Co., Ltd. — HIGHERDOSE Red Light Hat (HG-120K) (510k cleared)

Product code: OAP. Advisory committee: Physical Medicine. Type: Traditional

full page →fda device 510k ↗
›Nov 21, 2024approval652d agoLICART (DICLOFENAC EPOLAMINE) — FDA approvalAmzell Limited

Sponsor: IBSA INST BIO. Form: SYSTEM. Route: TOPICAL

full page →fda approvals ↗
›Nov 21, 2024approval652d agoCALDOLOR (IBUPROFEN) — FDA approvalCUMBERLAND PHARMACEUTICALS INC

Sponsor: CUMBERLAND PHARMS. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗
›Nov 21, 2024approval652d agoDICLOFENAC SODIUM — FDA approvalDICLOFENAC SODIUM

Sponsor: AUROBINDO PHARMA USA. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →DICLOFENAC SODIUM →fda approvals ↗
›Nov 21, 2024approval652d agoPONSTEL (MEFENAMIC ACID) — FDA approvalAvion Pharmaceuticals LLC

Sponsor: AVION PHARMS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Nov 21, 2024approval652d agoOXYCODONE HYDROCHLORIDE AND IBUPROFEN (IBUPROFEN) — FDA approvalMidol

Sponsor: ACTAVIS ELIZABETH. Form: TABLET. Route: ORAL

full page →Midol →fda approvals ↗
›Nov 21, 2024approval652d agoBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalNovitium Pharma LLC

Sponsor: STEVENS J. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Nov 21, 2024approval652d agoOXYCODONE HYDROCHLORIDE AND IBUPROFEN (IBUPROFEN) — FDA approvalMidol

Sponsor: BARR LABS INC. Form: TABLET. Route: ORAL

full page →Midol →fda approvals ↗
›Nov 21, 2024approval652d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalhydrocodone bitartrate ER

Sponsor: STRIDES PHARMA. Form: TABLET. Route: ORAL

full page →hydrocodone bitartrate ER →fda approvals ↗
›Nov 21, 2024approval652d agoPERCODAN (ASPIRIN) — FDA approvalEndo Pharmaceuticals Inc

Sponsor: ENDO OPERATIONS. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Nov 21, 2024approval652d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalANI PHARMACEUTICALS INC

Sponsor: ANI PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Nov 21, 2024approval652d agoBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

Sponsor: NOVITIUM PHARMA. Form: CAPSULE. Route: ORAL

full page →BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE →fda approvals ↗
›Nov 21, 2024approval652d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

Sponsor: ACTAVIS LABS FL INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Nov 21, 2024approval652d agoSYNALGOS-DC (ASPIRIN) — FDA approvalBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

Sponsor: SUN PHARM INDUSTRIES. Form: CAPSULE. Route: ORAL

full page →BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE →fda approvals ↗
›Nov 21, 2024approval652d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

Sponsor: SUN PHARM INDS INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Nov 21, 2024approval652d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalStrides Pharma Inc

Sponsor: AMNEAL PHARMS NY. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Nov 21, 2024approval652d agoHYDROCODONE BITARTRATE AND IBUPROFEN (HYDROCODONE BITARTRATE) — FDA approvalhydrocodone bitartrate ER

Sponsor: AUROLIFE PHARMA LLC. Form: TABLET. Route: ORAL

full page →hydrocodone bitartrate ER →fda approvals ↗
›Nov 21, 2024approval652d agoCARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalCosette Pharmaceuticals Inc

Sponsor: INGENUS PHARMS NJ. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Nov 21, 2024device 510k652d agoFink Engineering Pty, Ltd. — FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber (510k cleared)

Product code: CBF. Advisory committee: Anesthesiology. Type: Traditional

full page →fda device 510k ↗
›Nov 21, 2024device 510k652d agoVarian Medical Systems, Inc. — Gating Reflector Block (510k cleared)MERIT MEDICAL SYSTEMS INC

Product code: JAK. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗
›Nov 21, 2024device 510k652d agoLifenet Health — PliaFX Flo (510k cleared)

Product code: MBP. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗
›Nov 21, 2024device 510k652d agoIlooda Co,., Ltd. — Secret MAX Multi-platform RF System (510k cleared)

Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional

full page →fda device 510k ↗
›Nov 21, 2024device 510k652d agoKonica Minolta, Inc. — SKR 3000 (510k cleared)

Product code: MQB. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗
›Nov 21, 2024device 510k652d agoGM Dos Reis Industria e Comercio Ltda. — Versalock Mini and Micro Plating System (510k cleared)

Product code: HRS. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗
›Nov 21, 2024device 510k652d agoGeneral Vibronics, Inc. — MIRARI® Cold Plasma System ( GV-M2-01) (510k cleared)

Product code: PBX. Advisory committee: General, Plastic Surgery. Type: Traditional

full page →fda device 510k ↗
›Nov 21, 2024device 510k652d agoSurGenTec, LLC — TiLink-P Joint Fusion System (510k cleared)

Product code: OUR. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗
›Nov 21, 2024device 510k652d agoShenzhen Smallsignal Technology Co., Ltd. — Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH (510k cleared)

Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗
›Nov 21, 2024device 510k652d agoColoplast Corp. — Luja Coude (510k cleared)

Product code: EZD. Advisory committee: Gastroenterology, Urology. Type: Traditional

full page →fda device 510k ↗
›Nov 21, 2024device 510k652d agoJazz Imaging — Jazz Classic (510k cleared)

Product code: LLZ. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗
›Nov 21, 2024device 510k652d agoCepheid® — Xpert vanA (510k cleared)

Product code: NIJ. Advisory committee: Microbiology. Type: Special

full page →fda device 510k ↗
›Nov 21, 2024device 510k652d agoDepuy Ireland UC — ATTUNE™ Revision Hinge Knee (510k cleared)

Product code: KRO. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗
›Nov 21, 2024device 510k652d agoGM Dos Reis Industria e Comercio Ltda. — GMReis Ankle Plating System (510k cleared)

Product code: HRS. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗
›Nov 22, 2024approval651d agoTECVAYLI (TECLISTAMAB-CQYV) — FDA approvalteclistamab

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

full page →teclistamab →fda approvals ↗
›Nov 22, 2024approval651d agoRAPIBLYK (LANDIOLOL HYDROCHLORIDE) — FDA approvalAOP Health

Sponsor: AOP HLTH US. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗
›Nov 22, 2024approval651d agoHYDROCODONE BITARTRATE AND ASPIRIN (ASPIRIN) — FDA approvalPurdue Pharma LP

Sponsor: LGM PHARMA. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Nov 22, 2024approval651d agoLUNSUMIO (MOSUNETUZUMAB-AXGB) — FDA approvalmosunetuzumab

Sponsor: GENENTECH INC. Form: INJECTABLE. Route: INJECTION

full page →mosunetuzumab →fda approvals ↗
›Nov 22, 2024approval651d agoVRAYLAR (CARIPRAZINE HYDROCHLORIDE) — FDA approvalCARIPRAZINE HYDROCHLORIDE

Sponsor: ABBVIE. Form: CAPSULE. Route: ORAL

full page →CARIPRAZINE HYDROCHLORIDE →fda approvals ↗
›Nov 22, 2024device 510k651d agoFlower Orthopedics Corporation Dba Conventus Flower Ortho — OsteoCoil™ Nitinol Compression System (Multiple Component PNs) (510k cleared)

Product code: HWC. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗
›Nov 22, 2024device 510k651d agoPAJUNK GmbH Medizintechnologie — SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology (510k cleared)

Product code: BSP. Advisory committee: Anesthesiology. Type: Traditional

full page →fda device 510k ↗
›Nov 22, 2024device 510k651d agoXf Agencija Limited — Nooro Body & Foot Stimulator (SM9141, SM9142) (510k cleared)

Product code: NUH. Advisory committee: Neurology. Type: Traditional

full page →fda device 510k ↗
›Nov 22, 2024device 510k651d agoAdvamedix, GmbH — Suction Irrigation Tubing Set (510k cleared)

Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional

full page →fda device 510k ↗
›Nov 22, 2024device 510k651d agoNeuvotion, Inc. — Neuvotion NeuStim NN-01 (510k cleared)

Product code: GZI. Advisory committee: Neurology. Type: Traditional

full page →fda device 510k ↗
›Nov 22, 2024device 510k651d agoNova Biomedical Corporation — Nova Allegro HbA1c Assay, Nova Allegro Analyzer (510k cleared)

Product code: LCP. Advisory committee: Hematology. Type: Dual Track

full page →fda device 510k ↗
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$MMSI88.57-1.73%
$ABBV261.72+0.67%
$ANIP73.06+1.59%
$CPIX6.5200-0.61%
$BLNC