510(k) Clearances — Page 97
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K243533 — Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus | Hlb Co., Ltd. Healthcare Mon Jan 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243295 — Initia Knee System | Kyocera Medical Technologies, Inc. Mon Jan 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243262 — QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test | Osang, LLC Mon Jan 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243271 — MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Enhance Single Use Gel Sizer | Mentor Worldwide, LLC Mon Jan 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243909 — Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric | Alcon Laboratories, Inc. Mon Jan 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241059 — Pantheon Proximal Femur Reconstruction (PFR) System | Adler Ortho S.P.A Mon Jan 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242680 — LetsGetChecked Impress | Privapath Diagnostics Ltd (Dba Letsgetchecked) Mon Jan 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241431 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193) | Joytech Healthcare Co. , Ltd. Mon Jan 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242689 — AAMI Level 4 Protective; Gown | Azac Group Mon Jan 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243836 — Mentor CPX 4 PLUS Enhance Breast Tissue Expander | Mentor Worldwide, LLC Sun Jan 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241641 — Electric Wheelchair (YE200) | Shenzhen Yattll Industry Co., Ltd. Sat Jan 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243492 — Ulike Reglow Light Therapy Device (UM10) | Shenzhen Ulike Smart Electronics Co., Ltd. Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243111 — Bowhead ERA Wheelchairs | Bowhead Design Corp. Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242767 — Safecare Urinary Tract Infection Test | Safecare Biotech (Hangzhou) Co., Ltd. Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241781 — Solo Pace Control | Solo Pace, Inc. Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242366 — OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment | Overfibers S.R.L. Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242877 — BioCode Gastrointestinal Pathogen Panel (GPP) | Applied BioCode, Inc. Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242901 — ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN GBT Orogastric Tube - 40 Fr (ZZ-GBT-40) | Tools For Surgery, LLC Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241064 — Unscented Tampon | Shandong Intco Hygiene Products Co., Ltd. Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241764 — Mould Probe MR Safe | Varian Medical Systems, Inc. Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241891 — ScreenDx | Imvaria, Inc. Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241009 — PeriCALM Patterns 3.0 | Perigen, Inc. Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243806 — Safety Winged Blood Collection Sets | Promisemed Hangzhou Meditech Co., Ltd. Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243195 — Arthrex SS VAL and VAL KreuLock Compression Screw System | Arthrex, Inc. Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243477 — Universal Tendon Spacer | Askorn Medical Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243814 — NuVasive Pulse System | Globus Medical, Inc. Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242228 — Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01) | Triopsy Medical, Inc. Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241676 — TriVerity | Inflammatix, Inc. Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242528 — Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298) | Shenzhen Ruiankang Technology Co., Ltd. Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241174 — INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) | Carl Zeiss Meditec, AG Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242071 — Xpert Xpress CoV-2/Flu/RSV plus | Cepheid Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240267 — Klaxon (Twist); Klaxon (Twist R) | Klaxon Mobility GmbH Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243811 — Erchonia Zerona® VZ8 | Erchonia Corporation Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241273 — FullFocus | Paige.Ai, Inc. Thu Jan 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242805 — Dental Cone-beam Computed Tomography (FinScan F350) | Changzhou Finno Medical Technology Co., Ltd. Thu Jan 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242842 — ANNE View, Central Hub | Sibel Health, Inc. Wed Jan 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K240590 — Electrical Scooter, WT-T4SU | W'U'S Tech Co., Ltd. Wed Jan 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242290 — DormoTech NLab | Dormotech Medical, Ltd. Wed Jan 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243813 — QIAstat-Dx GI Panel 2 Mini B&V | QIAGEN GmbH Wed Jan 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241003 — HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) | Hiossen, Inc. Wed Jan 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241806 — Applied Biosystems TaqPath COVID-19, Flu A, Flu B, RSV Select Panel | Life Technologies Corporation Wed Jan 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242661 — TRI-matrix® X-Force Implants | Tri Dental Implants Int. AG Wed Jan 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243818 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Hartalega NGC Sdn. Bhd. Wed Jan 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243644 — Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302) | Ceragem Co., Ltd. Wed Jan 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242741 — ACE Cannula | Ace Medical Industry Co., Ltd. Wed Jan 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241489 — ReminGel | Inter-Med, Inc. Wed Jan 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K242043 — Sperm Freezing Medium | Gimbo Medical Technology Shenzhen Co., Ltd. Wed Jan 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241808 — ApolloHipX (THR.SS.0001) | Corin U.S.A. Limited Tue Jan 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K241456 — GlutenID Celiac Genetic Health Risk Test | Targeted Genomics, LLC Tue Jan 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K243335 — Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR | Canon Medical Systems Corporation Tue Jan 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |