510(k) Clearances — Page 181
Browse all FDA 510(k) medical device clearances. RegDataLab tracks 175,456 clearances from official FDA sources, updated on an ongoing basis.
| Clearances | Details |
|---|---|
| K231384 — Annalise Enterprise CTB Triage Trauma | Annalise-Ai Pty , Ltd. Fri Sep 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231678 — Overjet Periapical Radiolucency Assist | Overjet, Inc. Thu Sep 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232569 — CAREMIBRAIN | General Equipment For Medical Imaging, S.A. Thu Sep 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231401 — Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva | Poly Medicure Limited Thu Sep 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231248 — Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform | Edwards Lifesciencess, LLC Thu Sep 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230102 — Smart double sides wearable breast pump, Electric bilateral breast pump | Huizhou Lvb Maternal and Infant Supplies Co., Ltd. Thu Sep 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230226 — Integrity-SI® Fusion System | OsteoCentric Technologies Thu Sep 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230193 — Servator P Plus SALF Solution | S.A.L.F. Spa Thu Sep 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223354 — EGIS Biliary Single Bare Stent | S&G Biotech, Inc. Thu Sep 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230467 — BTL-899F | BTL Industries, Inc. Thu Sep 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223214 — Powder-Free Nitrile Examination Gloves | Global Protection Corp. Thu Sep 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232159 — QEVO System | Carl Zeiss Meditec, AG Thu Sep 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230767 — Pelvic Floor Muscle Stimulator | Nanjing Vishee Medical Technology Co., Ltd. Thu Sep 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230692 — TULSA-PRO System | Profound Medical, Inc. Wed Sep 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232582 — Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set | Ambu A/S Wed Sep 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K213987 — ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls | Biokit, S.A. Wed Sep 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231854 — 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM | Stryker Wed Sep 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223913 — Socrates Aspiration System | Scientia Vascular, Inc. Wed Sep 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232583 — Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. Wed Sep 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223179 — Cholestech LDX System | Alere San Diego, Inc. Wed Sep 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232592 — CITRELOCK® DUO | Acuitive Technologies, Inc. Wed Sep 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231894 — LED Spectrum therapy instrument | Shenzhenshi Sincoheren S&T Development Co., Ltd. Wed Sep 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232556 — DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System | Depuy Ireland UC Wed Sep 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231385 — Rology Teleradiology Platform (v.1.22.1103) | Rology, Inc. Wed Sep 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230011 — Mpact Extension | Medacta International S.A. Wed Sep 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231342 — Insufflator (OPTO-IFL1000) | Guangdong Optomedic Technologies, Inc. Wed Sep 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230239 — AirSeal iFS System; AirSeal dV Solution | Conmed Corporation Wed Sep 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230043 — Insulin Pen Needle | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Wed Sep 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223421 — MedCAD AccuPlan Orthopedics System | Medcad Wed Sep 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230966 — angiOCCLUDE Ligating Clips | A2 Medical Systems, LLC Tue Sep 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231281 — Aquilion Serve (TSX-307A/1) V1.3 | Canon Medical Systems Corporation Tue Sep 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222948 — Q Distal Access Catheter | Mivi Neuroscience, Inc. Tue Sep 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231802 — Millipede 088 Access Catheter | Perfuze, Ltd. Tue Sep 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231106 — Accuject Refra Injector AR2900 | Medicel AG Tue Sep 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232178 — GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) | DRGEM Corporation Tue Sep 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221309 — AI100 with Shonit | Sigtuple Technologies Pvt. , Ltd. Tue Sep 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231367 — Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221) | Shenzhen Finicare Co., Ltd. Mon Sep 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232530 — Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System | Nexus Spine, LLC Mon Sep 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232513 — X-Twist Biocomposite Suture Anchor | Parcus Medical Mon Sep 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232544 — Apollo ESG NXT System, Apollo REVISE NXT System | Apollo Endosurgery, Inc. Mon Sep 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231663 — The AVEOtsd (Tongue Stabilizing Device) Mouthpiece | Innovative Health Technologies (Nz), Ltd. Mon Sep 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223835 — MA-40, MA-112 | Medify Air, LLC Mon Sep 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222251 — B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA II KRYPTOR QC | B.R.A.H.M.S GmbH, Part of Thermo Fisher Mon Sep 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232172 — BTL-785BNF Handpiece | BTL Industries, Inc. Mon Sep 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231832 — Access Myoglobin | Beckman Coulter, Inc. Mon Sep 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231688 — ImPACT Version 4 | Impact Applications, Inc. Sat Sep 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230483 — Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) | Passy-Muir, Inc. Sat Sep 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K232315 — Catalyst Bone Void Filler | Ossdsign AB Fri Sep 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230946 — Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L | Trax Surgical Fri Sep 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230752 — Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) | FUJIFILM Healthcare Americas Corporation Fri Sep 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |