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calendar

33 catalysts · 24 device 510k · 9 approval

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  • device 510k24
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no tagged catalysts yet

Week of Oct 14, 2024

33
›Oct 18, 2024approval683d ago
ZEPBOUND (TIRZEPATIDE) — FDA approvalZEPBOUND

Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →ZEPBOUND →fda approvals ↗
›Oct 18, 2024approval683d agoZEPBOUND (TIRZEPATIDE) — FDA approvalZEPBOUND

Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →ZEPBOUND →fda approvals ↗
›Oct 18, 2024approval683d agoZEPBOUND (TIRZEPATIDE) — FDA approvalZEPBOUND

Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →ZEPBOUND →fda approvals ↗
›Oct 18, 2024approval683d agoZEPBOUND (TIRZEPATIDE) — FDA approvalZEPBOUND

Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →ZEPBOUND →fda approvals ↗
›Oct 18, 2024approval683d agoZEPBOUND (TIRZEPATIDE) — FDA approvalZEPBOUND

Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →ZEPBOUND →fda approvals ↗
›Oct 18, 2024approval683d agoSELARSDI (USTEKINUMAB-AEKN) — FDA approvalAlvotech

Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Oct 18, 2024approval683d agoSELARSDI (USTEKINUMAB-AEKN) — FDA approvalAlvotech

Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Oct 18, 2024approval683d agoSELARSDI (USTEKINUMAB-AEKN) — FDA approvalAlvotech

Sponsor: ALVOTECH USA INC. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Oct 18, 2024approval683d agoORGOVYX (RELUGOLIX) — FDA approvalrelugolix

Sponsor: SUMITOMO PHARMA AM. Form: TABLET. Route: ORAL

full page →relugolix →fda approvals ↗
›Oct 18, 2024device 510k683d agoStimlabs, LLC — Corplex P/ Theracor P/ Allacor P (510k cleared)

Product code: KGN. Advisory committee: Unknown. Type: Special

full page →fda device 510k ↗
›Oct 18, 2024device 510k683d agoPhilips Medical Systems Nederland B.V. — dS Knee Coil 8ch 1.5T (510k cleared)

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

full page →fda device 510k ↗
›Oct 18, 2024device 510k683d agoAidoc Medical , Ltd. — BriefCase-Triage (510k cleared)

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

full page →fda device 510k ↗
›Oct 18, 2024device 510k683d agoDentscare Ltda — Vittra APS Unique Flow (510k cleared)

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

full page →fda device 510k ↗
›Oct 18, 2024device 510k683d agoOrthosoft Inc. (d/b/a) Zimmer CAS — ROSA® Knee System (510k cleared)

Product code: OLO. Advisory committee: Neurology. Type: Special

full page →fda device 510k ↗
›Oct 18, 2024device 510k683d agoFabinject Lndustria E Comercio Lmportacao E Exportacao Ltda — FREDDO (510k cleared)

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

full page →fda device 510k ↗
›Oct 18, 2024device 510k683d agoEclectic Co., Ltd. — PreXolid CAD/CAM abutments (510k cleared)

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

full page →fda device 510k ↗
›Oct 18, 2024device 510k683d agoPhilips Medical Systems Technologies , Ltd. — Spectral CT 7500 RT (510k cleared)

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

full page →fda device 510k ↗
›Oct 18, 2024device 510k683d ago3M Company — 3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M) (510k cleared)3M CO

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

full page →fda device 510k ↗
›Oct 18, 2024device 510k683d agoMaterialise NV — Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (510k cleared)MATERIALISE NV

Product code: QHE. Advisory committee: Orthopedic. Type: Special

full page →fda device 510k ↗
›Oct 18, 2024device 510k683d agoSleepnet Corporation — Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask (510k cleared)

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

full page →fda device 510k ↗
›Oct 18, 2024device 510k683d agoAcro Biomedical Co., Ltd. — ABCcolla® Collagen ADM Scaffold (510k cleared)ACRO BIOMEDICAL CO., LTD.

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

full page →fda device 510k ↗
›Oct 18, 2024device 510k683d agoSafepath Medical, Inc. — SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture (510k cleared)

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

full page →fda device 510k ↗
›Oct 18, 2024device 510k683d agoBone Solutions, Inc. — Mg OSTEOREVIVE™, Mg OSTEOCRETE™ (510k cleared)UL Solutions Inc.

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

full page →fda device 510k ↗
›Oct 18, 2024device 510k683d agoEdelweiss Dentistry Products GmbH — edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK (510k cleared)

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

full page →fda device 510k ↗
›Oct 18, 2024device 510k683d agoPhilips Medical Systems Nederland B.V. — dS Wrist coil 8ch 1.5T (510k cleared)

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

full page →fda device 510k ↗
›Oct 18, 2024device 510k683d agoBoston Scientific Corp — IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) (510k cleared)BOSTON SCIENTIFIC CORP

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

full page →fda device 510k ↗
›Oct 18, 2024device 510k683d agoWellmed Dental Medical Supply Co., Ltd. — Dental Barrier and Sleeves (510k cleared)

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

full page →fda device 510k ↗
›Oct 18, 2024device 510k683d agoWell-Life Healthcare Limited — Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator (510k cleared)

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

full page →fda device 510k ↗
›Oct 18, 2024device 510k683d agoRestor3D — Kinos Total Ankle System (510k cleared)

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

full page →fda device 510k ↗
›Oct 18, 2024device 510k683d agoMvision AI OY — Contour+ (MVision AI Segmentation) (510k cleared)

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

full page →fda device 510k ↗
›Oct 18, 2024device 510k683d agoColoplast Corp. — Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) (510k cleared)

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

full page →fda device 510k ↗
›Oct 18, 2024device 510k683d agoXiantao Daoqi Plastic Co., Ltd. — Surgical Face Mask (Tie on/ Ear loops) (510k cleared)

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

full page →fda device 510k ↗
›Oct 18, 2024device 510k683d agoOystershell NV — Pixie Skin Tag (510k cleared)

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

full page →fda device 510k ↗
$LLY1174.61-0.13%
$MTLS6.5600-1.06%
$MMM
$LLY1174.61-0.13%
$ALVO4.9500+1.43%
$ALVO4.9500+1.43%
$ALVO4.9500+1.43%
$LLY1174.61-0.13%
$LLY1174.61-0.13%
$LLY1174.61-0.13%
$ACBM
$ULS
$BSX46.84+0.36%