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calendar

14 catalysts · 12 device 510k · 2 approval

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no tagged catalysts yet

Week of May 19, 2025

14
›May 19, 2025approval469d ago
SUBOXONE (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalBUPRENORPHINE HYDROCHLORIDE

Sponsor: INDIVIOR. Form: FILM. Route: BUCCAL, SUBLINGUAL

full page →BUPRENORPHINE HYDROCHLORIDE →fda approvals ↗
›May 19, 2025approval469d agoZUBSOLV (BUPRENORPHINE HYDROCHLORIDE) — FDA approvalEdenbridge Pharmaceuticals LLC

Sponsor: EDENBRIDGE PHARMS. Form: TABLET. Route: SUBLINGUAL

full page →fda approvals ↗
›May 19, 2025device 510k469d agoRowpar Pharmaceuticals, Inc. — CloSYS® Dry Mouth Sensitive Mouth Rinse (510k cleared)RVL Pharmaceuticals Inc

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

full page →fda device 510k ↗
›May 19, 2025device 510k469d agoSplintek, Inc. — SleepRight Snore Aid (510k cleared)

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

full page →fda device 510k ↗
›May 19, 2025device 510k469d agoRoute 92 Medical, Inc. — Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set (510k cleared)

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

full page →fda device 510k ↗
›May 19, 2025device 510k469d agoNanjing Perlove Medical Equipment Co., Ltd. — Diagnostic X-ray System (510k cleared)

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

full page →fda device 510k ↗
›May 19, 2025device 510k469d agoGigaalaser Company , Ltd. — Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) (510k cleared)

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

full page →fda device 510k ↗
›May 19, 2025device 510k469d agoDoc Brands, Inc. — Dentemp Pro-Comfort Dental Guard (510k cleared)BT Brands, Inc.

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

full page →fda device 510k ↗
›May 19, 2025device 510k469d agoBecton, Dickinson and Company — BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) (510k cleared)BECTON DICKINSON & CO

Product code: LON. Advisory committee: Microbiology. Type: Traditional

full page →fda device 510k ↗
›May 19, 2025device 510k469d agoShenzhen Mindray Bio-Medical Electronics Co., Ltd. — Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9); Diagnostic Ultrasound System (Recho R9 Pro); Diagnostic Ultrasound System (Recho R9 Exp); Diagnostic Ultrasound System (Recho R9S); Diagnostic Ultrasound System (Recho R9T); Diagnostic Ultrasound System (Crius R9 CV); Diagnostic Ultrasound System (Anesus R9 CV); Diagnostic Ultrasound System (Recho R9 Super); Diagnostic Ultrasound System (Recho R9 Lumi); Diagnostic Ultrasound System (Recho R CV); Diagnost (510k cleared)

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

full page →fda device 510k ↗
›May 19, 2025device 510k469d agoVision Rt, Ltd. — MapRT (510k cleared)Rail Vision Ltd.

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

full page →fda device 510k ↗
›May 19, 2025device 510k469d agoZhengzhou PZ Laser Slim Technology Co., Ltd. — Muscle Stimulator Device (PZ-100) (510k cleared)

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

full page →fda device 510k ↗
›May 19, 2025device 510k469d agoResmed Pty , Ltd. — AirFit F20 Mask System; AirFit F20 NM Mask System (510k cleared)

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

full page →fda device 510k ↗
›May 19, 2025device 510k469d agoRestor3D — restor3d Reverse Total Shoulder Arthroplasty System (510k cleared)

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

full page →fda device 510k ↗
$INDV34.87-1.22%
$BTBD
$RVSN4.4000-4.56%
$BDX189.52+0.74%