FDA 510(k) clearances — page 101
clearances on record, most recent first.
Clearances — page 101
10,001–10,100 of 176,479- K231446 — Single-Use Latex Sterile Surgical Gloves (SG100)
- K231479 — TriALTIS Spine System
- K231730 — FemaSeed Intratubal Insemination
- K231767 — Annalise Enterprise CTB Triage Trauma
- K232183 — IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10
- K232193 — Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03)
- K232224 — iLet® Dosing Decision Software
- K232558 — UroLift 2 ATC Advanced Tissue Control System
- K232571 — CATHTONG II PICC Catheter
- K232594 — CATHTONG II PICC Catheter
- K232978 — DX. Bond V Dental Bonding Adhesive
- K223214 — Powder-Free Nitrile Examination Gloves
- K223354 — EGIS Biliary Single Bare Stent
- K230102 — Smart double sides wearable breast pump, Electric bilateral breast pump
- K230193 — Servator P Plus SALF Solution
- K230226 — Integrity-SI® Fusion System
- K230467 — BTL-899F
- K230767 — Pelvic Floor Muscle Stimulator
- K231248 — Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform
- K231401 — Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva
- K231678 — Overjet Periapical Radiolucency Assist
- K232159 — QEVO System
- K232569 — CAREMIBRAIN
- K213987 — ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls
- K223179 — Cholestech LDX System
- K223421 — MedCAD AccuPlan Orthopedics System
- K223913 — Socrates Aspiration System
- K230011 — Mpact Extension
- K230043 — Insulin Pen Needle
- K230239 — AirSeal iFS System; AirSeal dV Solution
- K230692 — TULSA-PRO System
- K231342 — Insufflator (OPTO-IFL1000)
- K231385 — Rology Teleradiology Platform (v.1.22.1103)
- K231854 — 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM
- K231894 — LED Spectrum therapy instrument
- K232556 — DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System
- K232582 — Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set
- K232583 — Catalyst R1 Reverse Shoulder System
- K232592 — CITRELOCK® DUO
- K221309 — AI100 with Shonit
- K222948 — Q Distal Access Catheter
- K230966 — angiOCCLUDE Ligating Clips
- K231106 — Accuject Refra Injector AR2900
- K231281 — Aquilion Serve (TSX-307A/1) V1.3
- K231802 — Millipede 088 Access Catheter
- K232178 — GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)
- 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
- K223835 — MA-40, MA-112
- K231367 — Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221)
- K231663 — The AVEOtsd (Tongue Stabilizing Device) Mouthpiece
- K231832 — Access Myoglobin
- K232172 — BTL-785BNF Handpiece
- K232513 — X-Twist Biocomposite Suture Anchor
- K232530 — Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System
- K232544 — Apollo ESG NXT System, Apollo REVISE NXT System
- K230483 — Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
- K231688 — ImPACT Version 4
- K220735 — Avologi Gel Primer (Model: Av25)
- K220972 — Access Thyroglobulin
- K221860 — PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe
- K222610 — Elecsys Anti-Tg
- K223788 — The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter
- K223812 — Sensis Vibe (VD15)
- K223857 — i-STAT G3+ cartridge with the i-STAT 1 System
- K230066 — Carnation series Diagnostic Ultrasound System
- K230332 — Ambu® aScope Colon; Ambu® aBox 2
- K230752 — Over-tube (3 models)
- K230946 — Accelerate Compression Screw System-Small Product Code ACC-S +2 more
- K230974 — NIDO Pedicle Screw System
- K231235 — LW UCLA Abutment
- K231242 — Perifix FX Catheter; Contiplex FX Catheter
- K231336 — T2 Biothreat Panel
- K231791 — PENTO Nd:YAG and Alexandrite laser system
- K231827 — BTI Dental Implant System UnicCa® Aesthetic Post Abutments
- K232102 — ClearPoint Array System (Version 1.2)
- K232121 — Power wheelchair (Model:BC-EA8000)
- K232198 — Reclining wheelchair (YJ-011S 16D, YJ-011S 16DF, YJ-011S 18D, YJ-011S 18DF, YJ-011S 20D, YJ-011S 20DF)
- K232199 — Bariatric Heavy Duty Wheelchair (YJ-010B 20DS +23 more
- K232315 — Catalyst Bone Void Filler
- K232508 — Barrier EasyWarm Active Self-Warming Blanket
- K220034 — NEUROShield
- K223833 — Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays
- K223869 — ChoiceSpine Blackhawk Ti Cervical Spacer System
- K223885 — HOPKINS Telescopes
- K230108 — Straumann® BLC and TLC Implants
- K230167 — BACK 4
- K230237 — Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0)
- K230526 — TEA Device
- K230746 — Non absorbable Surgical Polypropylene Suture
- K230775 — SOFIA EX Intracranial Support Catheter
- K230959 — VitreJect® Needle; OcuSafe® Needle
- K230987 — FlowStar Analog Mixer Flowmeter
- K231030 — Cove Putty, OsteoCove Putty
- K231079 — LW Retraction Cap
- K231147 — Hammerdesis Interphalangeal Fusion System
- K231353 — AccuCTP Pro
- K231484 — PureWay 1.4 Quart Sharps Collector
- K231576 — cNeuro cPET
- K232124 — IPL Hair Removal, Model: W-1095, W-1098
- K232146 — Anovo Pedestal
Data sourced from openFDA. This site is unofficial and independent of the FDA.