510(k) Clearances — Page 168
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K230726 — CEREGLIDE 92 Intermediate Catheter | Cerenovus, Inc. Wed Nov 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232684 — Surgify Halo | Surgify Medical OY Wed Nov 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232033 — HYBRIDknife® flex | Erbe Elektromedizin GmbH Wed Nov 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232772 — Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,1207D1-1#,1207D1-2#,1207D1-3#,1207D1-4#,1207D1-5#,1201B1,12L2B1,1202B1,12L3B1,1203B1,1204B1,1205B1,1206B1,1207B1-1#,1207B1-2#,,1207B1-3#,1207B1-4#,1207B1-5#,1201W2,12L2W2,1202W2,12L3W2,1203W2,1204W2,1205W2,1206W2 and 1207W2) | Shenzhen Plinma Technology Co. , Ltd. Wed Nov 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231203 — Mosie Baby Kit | Mosie Baby Wed Nov 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233532 — MULTIX Impact E | Siemens Medical Solutions Wed Nov 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232012 — N1 | Osstem Implant Co., Ltd. Tue Nov 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231473 — Monarch Bronchoscope | Auris Health, Inc., A Johnson and Johnson Family Company Tue Nov 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232633 — Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter | Boston Scientific Tue Nov 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230883 — VersaPump Infusion System | Emed Technologies Corporation Tue Nov 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231250 — Digital Blood Pressure Monitor | Guangdong Genial Technology Co., Ltd. Tue Nov 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230947 — C.A.R.E. Appliance (DNA, mRNA, mmRNA) | Vivos Therapeutics, Inc. Tue Nov 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232643 — Cue COVID-19 Molecular Test | Cue Health, Inc. Tue Nov 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233414 — Shoreline ACS Interbody System; Shoreline RT Interbody System | SeaSpine Orthopedics Corporation Tue Nov 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233493 — Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024) | Relign Corporation Tue Nov 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232000 — syngo.via MI Workflows; Scenium; syngo MBF | Siemens Medical Solutions USA, Inc. Tue Nov 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232595 — Kinos Axiom Total Ankle System | Restor3D Tue Nov 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232117 — Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) | Wuhan Lotuxs Technology Co., Ltd. Tue Nov 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232713 — Blood Pressure Monitor | Guangdong Transtek Medical Electronics Co., Ltd. Tue Nov 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232252 — Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) | Dehai (Shandong) Medical Gloves, Co., Ltd. Tue Nov 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231631 — BriefCase-Quantification | Aidoc Medical , Ltd. Tue Nov 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222845 — Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece | Frey Oral Technologies, LLC Tue Nov 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233243 — ClearPoint System (Software Version 2.2) | ClearPoint Neuro, Inc. Mon Nov 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233343 — SteriCap Safety Needle; VitreJect Safety Needle | Ocuject, LLC Mon Nov 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232222 — Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) | Medency S.R.L. Mon Nov 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233332 — Statera-C Spinal System | K&J Consulting Corp. Mon Nov 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232624 — CardioPhase® hsCRP | Siemens Healthcare Diagnostic Products GmbH Mon Nov 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231104 — ABPMpro | Somnomedics GmbH Mon Nov 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232658 — T-Top 10 & T-Top T-Top 11 | Tuttnauer U.S.A Co, Ltd. Mon Nov 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230493 — BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube | Becton, Dickinson and Company Mon Nov 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230379 — Portable (Ultrasonic) Nebulizer | Dongguan Simzo Electronic Technology Co., Ltd. Mon Nov 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233171 — PF Keep; Cad Cam Keep Block | Clemde SA DE CV Mon Nov 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231661 — CryoThin Surgical System and Accessories | Medinux (Tianjin) Technologies Co., Ltd. Mon Nov 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233160 — NeuTrace EP Mapping System v.2.1 | Anumana, Inc. Sat Nov 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230319 — Passio Pump Drainage System | Bearpac Medical Fri Nov 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232059 — Tympanostomy Tubes | Grace Medical, Inc. Fri Nov 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230701 — Stim2Go | PAJUNK GmbH Medizintechnologie Fri Nov 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230311 — HyperSuture | Threadstone, LLC Fri Nov 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233525 — MF SC Facial Toning System | Micro Current Technology, Inc. Fri Nov 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222499 — Disposable Endoscope Valves Kit | Shanghai SeeGen Photoelectric Technology Co., Ltd. Wed Nov 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231245 — Digital Blood Pressure Monitor (Arm Type) | Guangdong Genial Technology Co., Ltd. Wed Nov 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232635 — IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100) | Boston Scientific Wed Nov 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231797 — Medifun Lancing Device, Model No. LD-E1 | Medifun Corporation Wed Nov 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232600 — DxFLEX Flow Cytometer; ClearLLab 10C Panels | Beckman Coulter, Inc. Wed Nov 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232593 — FITme Customized Silicone Implant | Keosan Trading Co. Wed Nov 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233078 — Posterior Cervical Spine System | Double Medical Technology, Inc. Wed Nov 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222712 — Fogg System Patient Monitoring Cables | Fogg System Company, Inc. Wed Nov 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K233110 — Carnation Ambulatory Monitor | Bardy Diagnostics, Inc. Wed Nov 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230529 — HealiAid Dental Collagen Wound Dressing | Maxigen Biotech, Inc. Wed Nov 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232621 — Blood pressure monitor | Guangdong Transtek Medical Electronics Co., Ltd. Wed Nov 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |