FDA 510(k) clearances — page 180
clearances on record, most recent first.
Clearances — page 180
17,901–18,000 of 175,699- K202159 — actiTENS
- K202211 — Disposable Medical Surgical Face Masks
- K202229 — AI Metrics
- K202298 — Lucent XP, Lucent XP Curved
- K202348 — External Remote Controller ERC 4P
- K202820 — Australis Anterior Lumbar Cage System
- K202849 — Everyway Analog OTC TENS, model N103A/N302
- K202968 — Da Vinci SP Surgical System
- K202974 — DenTek Fresh Protect Dental Guard
- K203066 — COOLIEF Cooled Radiofrequency Kit Advanced
- K203281 — Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X
- K203437 — Serranator PTA Serration Balloon Catheter
- K203447 — iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement
- K203452 — Nano FortiFix® System
- K203476 — CAPERE Thrombectomy System
- K203504 — Cios Flow
- K203552 — Rapid Reboot
- K192308 — Wu's Electrical Scooter
- K201113 — Resascope RS-01/B
- K201996 — Monocryl Plus Antibacterial Suture
- K202782 — num Vapocoolant
- K202979 — MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra
- K203445 — Trigon HA Stand-Alone Wedge Fixation System
- K201077 — Strados Remote Electronic Stethoscope Platform (RESP)
- K203178 — Flexitouch Plus System
- K202005 — NovoFine Plus 32G Tip x 4 mm
- K202668 — Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm2 per Glove of Extractable Protein
- K191978 — Fever Garde
- K201075 — BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter
- K201185 — microINR System
- K201250 — SQuEEZ Software
- K201555 — EchoGo Pro
- K201606 — LacriJet®
- K201980 — Infrared Thermometer
- K202006 — ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System
- K202026 — Blue Sky Bio CAD-CAM Abutments
- K202345 — FlowTriever Retrieval/Aspiration System
- K202361 — UltraSlim Digital, UltraSmooth Digital
- K202412 — ClearRT Helical kVCT for the Radixact Treatment Delivery System
- K202749 — ADAPT for Gamma3
- K202812 — IdentiTi Cervical Standalone Interbody System
- K203125 — Invictus OCT Spinal Fixation System
- K203126 — S10 Kirra
- K203162 — Advanix Biliary Stent with NaviFlex RX Delivery System
- K203172 — MOSAIQ Oncology Information System
- K203461 — Aesculap Caiman 12 Seal and Cut Technology System
- K203551 — Alphenix, INFX-8000V/B, /S, V9.1
- K190217 — Aidite PMMA
- K192770 — S dispensing line
- K200264 — Exofin High Viscosity Topical Skin Adhesive
- K200342 — Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use Grasping Forceps FG-226C, Single Use Grasping Forceps FG-232L, Single Use Grasping Forceps FG-804L
- K200346 — Wrist Type Blood Pressure Monitor
- K200730 — pjur WOMAN Nude pjur med SENSITIVE glide
- K200857 — Electric wheelchair (Model: S7012)
- K201081 — AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter
- K201165 — In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath
- K201594 — Primelase Excellence
- K201905 — SMR 140° Reverse Humeral Body
- K201919 — Blue Sky Bio TAD
- K202925 — KARL STORZ ICG Imaging System
- K203004 — ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
- K203163 — ARx Illiac Spinal Screw System
- K203222 — PERLA TL Posterior Osteosynthesis System
- K203303 — Emprint SX Ablation Platform with Thermosphere Technology
- DEN200035 — BEAR (Bridge-Enhanced ACL Repair) Implant
- K200291 — CREED Cannulated Screws
- K200549 — Lucero Medical Cervical Cage System
- K201031 — NRFit® Caps, Male and Female Neuraxial Tip Caps
- K201213 — Pasteur Pipette 3mL, Pasteur Pipette 1mL
- K201509 — Disposable Stone Extraction basket
- K202028 — dermalux Flex MD
- K202029 — Medical Surgical Mask
- K202095 — CreoDent Solidex Customized Abutment and Screw
- K202289 — ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
- K203097 — HydroMARK Breast Biopsy Site Markers
- K203180 — Arthrex DynaNite Nitinol Staples
- K203349 — Longeviti ClearFit Cranial Implant
- K203414 — DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System
- K192709 — Fixone All Suture Anchor
- K200971 — 308nm Excimer System
- K201755 — WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System
- K201808 — X-Tack Endoscopic HeliX Tacking System
- K202226 — Lim Precision Steerable TS, Steerable Sheath, Dilator
- K202230 — NEXXT MATRIXX Stand Alone ALIF System
- K202337 — Pulsed electromagnetic field wrap
- K202601 — Single-use Sterile medical laser fiber
- K202698 — Prefilled Syringe
- K202827 — 308nm Excimer UV-light Skin Therapy System
- K203383 — Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62
- K203401 — Neocis Guidance System (NGS) with Patient Splints (EPS)
- K200374 — Columbus Guidewire
- K201084 — Physica system
- K201284 — Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use
- K201495 — Maxxi Flow Sensor
- K201629 — Medical Face Mask
- K201735 — PlaDuo System
- K202222 — Irrisept Wound Debridement and Cleansing System
- K202324 — Fingertip Pulse Oximeter
- K202467 — Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads
- K202610 — Ventrax Delivery System
Data sourced from openFDA. This site is unofficial and independent of the FDA.