Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

FRO 2024-01-11

Copper Foam Dressing (Prescription and OTC)

Applicant Roosin Medical Co., Ltd.

K-Number K231088

View Details →

IYN 2024-01-11

U-Lite PRO

Applicant Sonoscanner Sarl

K-Number K232285

View Details →

FGB 2024-01-11

CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR)

Applicant MacroLux Medical Technology Co., Ltd.

K-Number K231774

View Details →

PKL 2024-01-11

Disposable Hemoclip (AF series)

Applicant Alton (Shanghai) Medical Instruments Co., Ltd.

K-Number K231633

View Details →

QWT 2024-01-11

BrainSee

Applicant Darmiyan, Inc.

K-Number DEN220066

View Details →

GXY 2024-01-11

Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005; Electrotherapy device Electrode belt for back of body, AC2001, AC2002, AC2003, AC2004; Electrotherapy device Electrode belt for Body joints, AC3001, AC3008, AC3009, AC3010, AC3011; Electrotherapy device Electrode for Knee, AC3002, AC3004, AC3006; Electrotherapy device Electrode for Elbow, AC3003, AC3005, AC3007; Electrothe

Applicant Shenzhen Roundwhale Technology Co. , Ltd.

K-Number K232995

View Details →

JAA 2024-01-11

ProxiDiagnost N90 / Precision CRF (706110, 706400)

Applicant Philips Medical Systems Dmc GmbH

K-Number K233945

View Details →

OHT 2024-01-11

IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY,UI06 IG,)

Applicant Shenzhen Ulike Smart Electronics Co., Ltd.

K-Number K233664

View Details →

PNN 2024-01-11

Clevaligner Software (V1.0.0)

Applicant Clevaligner, Ltd.

K-Number K233616

View Details →

MBF 2024-01-11

PRIMA Humeral System; PRIMA TT Glenoid

Applicant Lima Corporate S.P.A.

K-Number K233712

View Details →

ONB 2024-01-11

ToxiSeal Vial Adapter with External Balloon

Applicant Epic Medical Pte. , Ltd.

K-Number K222929

View Details →

HAW 2024-01-10

Zeta Cranial Navigation System (ZNS131-US)

Applicant Zeta Surgical, Inc.

K-Number K233903

View Details →

Page 627 of 2685

↑