FDA 510(k) clearances — page 38
clearances on record, most recent first.
Clearances — page 38
3,701–3,800 of 175,620- K250001 — Patriot SI Implant System
- K250529 — Globe Introducer (601-01001)
- K250598 — Endoform Reconstructive Template - PLGA
- K250657 — gi2000 Electrosurgical Generator
- K250682 — BD Nexiva Diffusics Closed IV Catheter System and BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector
- K251035 — DISINTEK PA Test Strips
- K251127 — PENTAX Medical Video Processor (EPK-i8020c)
- K250410 — GORE® Tri-Lobe Balloon Catheter
- K250452 — CoralWell Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B)
- K250844 — PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP T; RIGIDLOOP Clip; RIGIDLOOP BTB; RIGIDLOOP Suture Loop
- K250965 — Automated Blood Coagulation Analyzer CN-Series (CN-6000)
- K251335 — Tera Lumbar Interbody Fusion System (Various PNs)
- K251376 — LimFlow ARC
- DEN240047 — Allix5
- K241313 — OHC COVID-19 Antigen Self Test
- K242635 — Endoscopic Distal Attachment (AF-D series)
- K242640 — FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin
- K242725 — Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)
- K242751 — ARIX Pectus Bar System
- K242830 — LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer
- K242926 — XBody Go USA, XBody Pro USA
- K243005 — AudaxCeph Cephalogram Analysis Software
- K243010 — Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Proce
- K243505 — 5008X Hemodialysis System
- K243522 — ViVi® Toga Premium
- K243530 — Dynamic TiBase
- K243654 — DentalJect
- K243863 — Opulus Lymphoma Precision
- K250024 — TE Air Diagnostic Ultrasound System
- K250078 — Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)
- K250150 — VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)
- K250195 — MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)
- K250236 — Swoop® Portable MR Imaging® System (V2)
- K250317 — EsFlow PLUS
- K250365 — Motif Aura Glow breast pump (Model Motif Aura Glow)
- K250368 — Wearable Breast Pump (Model S21)
- K250581 — KALA Red Light Face Mask (KALA-01)
- K250637 — VCFix Spinal System
- K250957 — Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D)
- K251063 — TekBrace Solo Soft Tissue Reinforcement Device
- K251238 — Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010)
- K251383 — Prestige Coil System (Prestige Packing Line Extension)
- K251406 — BriefCase-Triage
- DEN240048 — Spur Peripheral Retrievable Stent System
- K243309 — 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)
- K243372 — BiliWrap
- K243469 — SIGNEX
- K243480 — SuturePatch Tissue Reinforcement
- K243484 — PM2+ System and SmartPICC Stylet
- K243497 — Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US
- K243856 — TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026)
- K250048 — NEUROMARK System (NMK00301)
- K250215 — Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand
- K250307 — Visualase V2 MRI-guided Laser Ablation System (9736422)
- K250543 — Voluson Performance 16; Voluson Performance 18
- K250606 — Dental Barrier and Sleeves
- K250673 — CERABIEN MiLai
- K250757 — Radius VSM and Accessories
- K251315 — Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II
- K251325 — VersaCross Connect Transseptal Dilator
- K251340 — ProSeal Bag Spike with Additive Port (423370ST, 423370)
- K240950 — Disposable Prophy Angle
- K242699 — Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12)
- K242752 — MRidium 3870 MRI Infusion Pump System (3870)
- K242793 — Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters Insight Workstation iS-PF1.
- K243047 — Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing
- K243378 — Rapid MLS
- K243716 — Zionic Pro Max (Radiofrequency)
- K243949 — OsteoFlo HydroFiber
- K244049 — Europa (Alternative: AiRTouch) portable X-ray system
- K250367 — CoLumboX
- K250427 — TAIMedImg DeepMets
- K250624 — myAir
- K251344 — OptiMap System
- K242604 — Helios+ UV-C System
- K242611 — Integral Dental Units
- K242820 — Puritan PurSafe Plus Collection and Transport System
- K242841 — Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)
- K243777 — Rennou Varnish (3% / Spearmint); Rennou Varnish (3% / Strawberry); Rennou Varnish (3% / Cherry); Rennou Varnish (3% / Bubble Gum)
- K250435 — Dexter L6 System
- K250475 — Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3)
- K250573 — Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M
- K250614 — Neodent Implant System - Custom Abutments
- K250932 — DeepRhythmAI
- K251309 — OSSIOfiber® Suture Anchor
- K251578 — BEAUTIFIL II
- K242545 — RadiForce MX317W-PA
- K242575 — Stereotaxic Guiding Surgical Devices, NaoTrac S
- K242594 — DEEPECHO
- K243023 — WiZARD 520 Full Face Mask
- K243261 — FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L
- K243474 — MagnetOs MIS
- K243937 — Accuro 3S
- K243989 — Second Opinion® 3D
- K244047 — Navi Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)
- K250005 — Clever One
- K250239 — NeuroMatch
- K250361 — SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1
- K250384 — IPL400
- K250446 — Frida Anterior Cervical Plate System
Data sourced from openFDA. This site is unofficial and independent of the FDA.