510(k) Clearances — Page 127

176,223 clearances total

Browse all FDA 510(k) medical device clearances. RegDataLab tracks 176,223 clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances (page 127 of 3,525)
ClearancesDetails
K242183 — Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd. Oct 23, 2024
K242193 — Arm Type Blood Pressure Monitor (BPM82)Avita Corporation Oct 22, 2024
K241572 — ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)Siemens Medical Solutions USA, Inc. Oct 22, 2024
K241758 — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)Stryker Sustainability Solutions Oct 22, 2024
K241478 — Tri-Wedge PTA Scoring Balloon Dilatation CatheterBrosmed Medical Co., Ltd. Oct 22, 2024
K243209 — nordicMEDiVANordicneurolab AS Oct 22, 2024
K242099 — Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without NeedleSol-Millennium Medical, Inc. Oct 22, 2024
K242250 — PuraStat3-D Matrix Europe SAS Oct 22, 2024
K241398 — SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd. Oct 22, 2024
K241532 — Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)Shanghai SeeGen Photoelectric Technology Co., Ltd. Oct 22, 2024
K240506 — KARL STORZ HoldersKarl Storz Endoscopy America, Inc. Oct 22, 2024
K240783 — Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc. Oct 21, 2024
K242157 — Anovo Surgical System (Model 6Ne)Momentis Surgical , Ltd. Oct 21, 2024
K242058 — Digital Prism Correction Feature (DPCF)Apple, Inc. Oct 21, 2024
K240029 — Zio AT® device (A100A1001)iRhythm Technologies, Inc. Oct 21, 2024
K242266 — PhotonBlade 3; PhotonBlade 3 Smoke EvacuationStryker Instruments Oct 21, 2024
K222740 — Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inchSpeciality Fibres And Materials, Ltd. Oct 21, 2024
K242554 — Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc. Oct 21, 2024
K241170 — Dynamic TiBase; TRI ScrewsTalladium España, SL Oct 21, 2024
K240844 — Spectral CT 7500 RTPhilips Medical Systems Technologies , Ltd. Oct 18, 2024
K241959 — 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)3M Company Oct 18, 2024
K242372 — Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc. Oct 18, 2024
K222944 — SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene SutureSafepath Medical, Inc. Oct 18, 2024
K233054 — Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus StimulatorWell-Life Healthcare Limited Oct 18, 2024
K233378 — ABCcolla® Collagen ADM ScaffoldAcro Biomedical Co., Ltd. Oct 18, 2024
K232994 — Vittra APS Unique FlowDentscare Ltda Oct 18, 2024
K242435 — Dental Barrier and SleevesWellmed Dental Medical Supply Co., Ltd. Oct 18, 2024
K241490 — Contour+ (MVision AI Segmentation)Mvision AI OY Oct 18, 2024
K242837 — BriefCase-TriageAidoc Medical , Ltd. Oct 18, 2024
K242868 — Kinos Total Ankle SystemRestor3D Oct 18, 2024
K242828 — Corplex P/ Theracor P/ Allacor PStimlabs, LLC Oct 18, 2024
K241131 — 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-BLOCKEdelweiss Dentistry Products GmbH Oct 18, 2024
K243033 — dS Wrist coil 8ch 1.5TPhilips Medical Systems Nederland B.V. Oct 18, 2024
K242813 — Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerMaterialise NV Oct 18, 2024
K242864 — ROSA® Knee SystemOrthosoft Inc. (D/B/A) Zimmer CAS Oct 18, 2024
K240226 — Pixie Skin TagOystershell NV Oct 18, 2024
K242879 — dS Knee Coil 8ch 1.5TPhilips Medical Systems Nederland B.V. Oct 18, 2024
K240725 — PreXolid CAD/CAM abutmentsEclectic Co., Ltd. Oct 18, 2024
K242132 — FREDDOFabinject Lndustria E Comercio Lmportacao E Exportacao Ltda Oct 18, 2024
K240916 — Surgical Face Mask (Tie on/ Ear loops)Xiantao Daoqi Plastic Co., Ltd. Oct 18, 2024
K241830 — Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented MaskSleepnet Corporation Oct 18, 2024
K242473 — Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)Coloplast Corp. Oct 18, 2024
K243245 — IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)Boston Scientific Corp Oct 18, 2024
K241267 — Hidroxa SE30Hidroxa Medical AB Oct 17, 2024
K240218 — Electric Breast Pump (F5055)Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. Oct 17, 2024
K240321 — MP Pin flat without thread (36BMP000020/MP20)Hager& Meisinger GmbH Oct 17, 2024
K242899 — NOVA Minimally Invasive SystemBaui Biotech Co., Ltd. Oct 17, 2024
K240408 — REMI-AI Rapid Detection Module (REMI-AI RDM)Epitel, Inc. Oct 17, 2024
K242809 — Ascent Cardiorespiratory Diagnostic SoftwareMedical Graphics Corporation Oct 17, 2024
K240711 — Zipline Access CatheterPerfuze, Ltd. Oct 17, 2024
← Previous Page 127 of 3525 Next →