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calendar

27,004 catalysts · 17,239 approval · 3,880 device 510k · 2,448 grant · 1,398 device recall · 1,179 device pma · 860 recall

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  • approval17,239
  • device 510k3,880
  • grant2,448
  • device recall1,398
  • device pma1,179
  • recall860
therapy area

no tagged catalysts yet

Week of Apr 28, 2025

29
›May 1, 2025device 510k491d agoInnovative Sterilization Technologies — ONE TRAY® Sealed Sterilization Container System (510k cleared)

Product code: KCT. Advisory committee: General Hospital. Type: Traditional

full page →fda device 510k ↗
›May 1, 2025device 510k491d agoShenzhen Qianyu Technology Co., Ltd. — Wrinkle Treatment Device (JM1, JM2B) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

full page →fda device 510k ↗
›May 1, 2025device 510k491d agoAlembic, LLC — APRO 45 Catheter (510k cleared)Alembic Pharmaceuticals Inc

Product code: DQY. Advisory committee: Cardiovascular. Type: Special

full page →fda device 510k ↗
›May 1, 2025device 510k491d agoParagon 28, Inc. — APEX 3D Total Ankle Replacement System (510k cleared)

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

full page →fda device 510k ↗
›May 1, 2025device 510k491d agoCepheid® — Xpert Xpress CoV-2/Flu/RSV plus (510k cleared)

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

full page →fda device 510k ↗
›May 1, 2025device 510k491d agoTraferox Technologies, Inc. — X°Port Lung Preservation System; X°Port Lung Preservation Solution (510k cleared)TETRA TECHNOLOGIES INC

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

full page →fda device 510k ↗
›May 1, 2025device 510k491d agoBioHorizons Implant Systems, Inc. — Conical Ti Base abutments (510k cleared)

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

full page →fda device 510k ↗
›May 1, 2025device 510k491d agoUnited Orthopedic Corporation — Resolve Modular Revision Hip Stem (510k cleared)

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

full page →fda device 510k ↗
›May 1, 2025device 510k491d agoCirca Scientific, Inc. — CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) (510k cleared)Clear Scientific Inc

Product code: DXF. Advisory committee: Cardiovascular. Type: Special

full page →fda device 510k ↗
›May 1, 2025device 510k491d agoGE Medical Systems Ultrasound and Primary Care Diagnostics — Vscan Air (510k cleared)

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

full page →fda device 510k ↗
›May 2, 2025approval490d agoTICAGRELOR — FDA approvalTICAGRELOR

Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

full page →TICAGRELOR →fda approvals ↗
›May 2, 2025device 510k490d agoPfm Medical, Inc. — JetCan® Pro Safety Huber Needle (510k cleared)Picard Medical, Inc.

Product code: FPA. Advisory committee: General Hospital. Type: Traditional

full page →fda device 510k ↗
›May 2, 2025device 510k490d agoShockwave Medical, Inc. — Shockwave CS Guide Catheter (510k cleared)

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

full page →fda device 510k ↗
›May 2, 2025device 510k490d agoHathor Professional Skincare , Ltd. — Sutil Rich Personal Lubricant (510k cleared)

Product code: NUC. Advisory committee: Obstetrics/Gynecology. Type: Traditional

full page →fda device 510k ↗
›May 2, 2025device 510k490d agoSignature Orthopaedics Pty, Ltd. — Origin™ Cemented Hip Stem (510k cleared)

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

full page →fda device 510k ↗
›May 2, 2025device 510k490d agoBeijing Rongrui-Century Science & Technology Co., Ltd. — SpO2 Extension Cable (510k cleared)

Product code: DSA. Advisory committee: Cardiovascular. Type: Special

full page →fda device 510k ↗
›May 2, 2025device 510k490d agoAbbott Point of Care, Inc. — i-STAT CG4+ cartridge with the i-STAT 1 System (510k cleared)

Product code: CHL. Advisory committee: Clinical Chemistry. Type: Traditional

full page →fda device 510k ↗
›May 2, 2025device 510k490d agoSg Endoscopy Pte, Ltd. — F88 URE-SD/RD Flexible Ureteroscope (510k cleared)

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

full page →fda device 510k ↗
›May 2, 2025device 510k490d agoSTERIS Corporation — Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 (510k cleared)STERIS plc

Product code: JOJ. Advisory committee: General Hospital. Type: Special

full page →fda device 510k ↗
›May 2, 2025device 510k490d agoSeriously Clean, Ltd. — Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel (510k cleared)

Product code: FRO. Advisory committee: Unknown. Type: Traditional

full page →fda device 510k ↗
›May 2, 2025device 510k490d agoAtsens Co., Ltd. — AT-Patch (ATP-C130/ATP-C70) (510k cleared)

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

full page →fda device 510k ↗
›May 2, 2025device 510k490d agoMedical Electronic Systems , Ltd. — SQA-iOw Sperm Quality Analyzer (510k cleared)

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

full page →fda device 510k ↗
›May 2, 2025device 510k490d agoCionic, Inc. — CIONIC NEURAL SLEEVE (NS-200) (510k cleared)

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

full page →fda device 510k ↗
›May 2, 2025device 510k490d agoSkydance Vascular, Inc. — OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) (510k cleared)

Product code: FOZ. Advisory committee: General Hospital. Type: Traditional

full page →fda device 510k ↗
›May 2, 2025device 510k490d agoIntradys — LUMYS (V1) (510k cleared)

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

full page →fda device 510k ↗
›May 2, 2025device 510k490d agoShenzhen AOJ Medical Technology Co., Ltd. — Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo (510k cleared)NewBay Medical Technology Co Ltd

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

full page →fda device 510k ↗
›May 2, 2025device 510k490d agoKarl Storz SE & CO. KG — KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2) (510k cleared)

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

full page →fda device 510k ↗
›May 2, 2025device 510k490d agoBrightheart — Fetal EchoScan (v1.1) (510k cleared)

Product code: POK. Advisory committee: Radiology. Type: Special

full page →fda device 510k ↗
›May 2, 2025device 510k490d agoMomentis Surgical , Ltd. — Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode (510k cleared)

Product code: QNM. Advisory committee: General, Plastic Surgery. Type: Special

full page →fda device 510k ↗

Week of May 5, 2025

21
›May 5, 2025approval487d agoTICAGRELOR — FDA approvalInvaGen Pharmaceuticals Inc

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

full page →fda approvals ↗
›May 5, 2025approval487d agoFENSOLVI KIT (LEUPROLIDE ACETATE) — FDA approvalLEUPROLIDE ACETATE

Sponsor: TOLMAR. Form: POWDER. Route: SUBCUTANEOUS

full page →LEUPROLIDE ACETATE →fda approvals ↗
›May 5, 2025device 510k487d agoZamar Medical D.O.O. — ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) (510k cleared)

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

full page →fda device 510k ↗
›May 5, 2025device 510k487d agoAevice Health Pte. , Ltd. — AeviceMD (510k cleared)

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

full page →fda device 510k ↗
›May 5, 2025device 510k487d agoGenoss Co., Ltd. — Bluemoon (510k cleared)

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

full page →fda device 510k ↗
›May 5, 2025device 510k487d agoPhilips Medizin Systeme Böblingen GmbH — Telemetry Monitor 5500 Release 4.0 (867232) (510k cleared)

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

full page →fda device 510k ↗
›May 5, 2025device 510k487d agoThermasolutions, LLC — ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) (510k cleared)

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

full page →fda device 510k ↗
›May 5, 2025device 510k487d agoPearl, Inc. — Second Opinion® Pediatric (510k cleared)

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

full page →fda device 510k ↗
›May 5, 2025device 510k487d agoAsiga Pty, Ltd. — DentaTOOTH (510k cleared)

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

full page →fda device 510k ↗
›May 5, 2025device 510k487d agoArthrex, Inc. — Arthrex Synergy Vision Endoscopic Imaging System (510k cleared)

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

full page →fda device 510k ↗
›May 5, 2025device 510k487d agoDae Myung Chemical Co., Ltd. (Vietnam) — Dream Medi Sterile Surgical Gown (SurgicalGownUL) (510k cleared)

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

full page →fda device 510k ↗
›May 6, 2025approval486d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗
›May 6, 2025device 510k486d agoMentice Spain S.L. — ANKYRAS (510k cleared)

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

full page →fda device 510k ↗
›May 6, 2025device 510k486d agoWontech Co., Ltd. — Alma Veil (510k cleared)

Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Special

full page →fda device 510k ↗
›May 6, 2025device 510k486d agoSolutions For Tomorrow AB — !M1 (510k cleared)

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

full page →fda device 510k ↗
›May 6, 2025device 510k486d agoHunan Vathin Medical Instrument Co., Ltd. — Single-use Flexible Ureteroscope (510k cleared)

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

full page →fda device 510k ↗
›May 6, 2025device 510k486d agoFoshan Newface Electronic Technology Co., Ltd. — IPL Hair Removal Device (NV-TM10A, NV-TM10C, NV-TM10D) (510k cleared)

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

full page →fda device 510k ↗
›May 6, 2025device 510k486d agoDongguan Boyuan Intelligent Technology Co.,Ltd — IPL Hair Removal Device (KCA511/KCA516/KCA522) (510k cleared)

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

full page →fda device 510k ↗
›May 7, 2025approval485d agoSKYRIZI (RISANKIZUMAB-RZAA) — FDA approvalrisankizumab

Sponsor: ABBVIE INC. Form: INJECTABLE. Route: INTRAVENOUS

full page →risankizumab →fda approvals ↗
›May 7, 2025approval485d agoSKYRIZI (RISANKIZUMAB-RZAA) — FDA approvalrisankizumab

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

full page →risankizumab →fda approvals ↗
›May 7, 2025recall485d agoACCORD HEALTHCARE, INC. recall (Cls II)HCA Healthcare, Inc.

Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-450-17 — Reason: Subpotent — Status: Ongoing

full page →fda recalls ↗
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$FRTRY
$STE230.35+0.30%
$ABBV261.72+0.67%
$PMI0.1821-4.66%
$HCA402.06-2.79%
$ABBV261.72+0.67%
$TTI