FDA 510(k) clearances — page 22
clearances on record, most recent first.
Clearances — page 22
2,101–2,200 of 176,479- K240934 — Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3) +2 more
- K250655 — Deep Capsule® (Deep Capsule US)
- K250794 — InVera Infusion Device
- K251584 — Medical Mesh Nebulizer (AirICU Max+)
- K251750 — Trax EX Anchor
- K251888 — VPAP Pediatric Face Mask
- K251964 — Mimics Thoracic Planner
- K252089 — Tyto Stethoscope (G3)
- K252110 — Dental X-RAY Unit (AJX200)
- K252401 — implaFit® short stems
- K252541 — Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W
- K252546 — VantageTM Lumbar Decompression Kit
- K252583 — Mini Moon electric breast pump (PA221); Moon Wave electric breast pump (PA220)
- K252824 — Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head
- K253062 — Tigertriever 25 Revascularization Device
- K253429 — Genadyne ASTRA NPWT
- K253525 — Urocross Expander System (Model Numbers ES2018 and ES3025)
- K253566 — Affixus Retrograde Femoral Nailing System
- K253636 — Zionic Pro Max (EMS)
- K253734 — Taurus Clip
- K253743 — MiniMed Flex pump
- K253936 — Power Mobility Scooter (MJMA01, MJMA02)
- K254040 — LungFlow Basket Catheter
- K254233 — MEDPOR Customized Implant Kit
- K260453 — Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)
- K260502 — Liv Pre-lubricated Intermittent Catheter
- K250937 — Venous Return Cannulae
- K252028 — LUOFUCON® Antimicrobial Wound Gel
- K253185 — Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System
- K253624 — INHANCE Reverse Shoulder System
- K253693 — Strut Suture; No-Tie Button
- K253906 — Xpert Hand
- K253986 — da Vinci Force Feedback Instruments
- K254047 — Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025)
- K254197 — Picasso Pro Diode Laser (002-00460)
- K260783 — Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One
- K252168 — Straumann® BLC Implants - Indication Widening
- K252353 — myray ProXIma X6
- K253517 — Reselute Tibial Nail
- K253584 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)
- K253953 — IPS e.max Zirconia
- K254093 — DePuy Synthes VOLT Medial Distal Femur 3.5 Plating System
- K260595 — Sonosite iLOOK Ultrasound System
- K260765 — Gemini NOVA 810+980 Soft Tissue Laser
- K260773 — Varios Combi Pro2
- K251861 — FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000
- K252888 — NeoSculpt Plus
- K253189 — Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)
- K253413 — LiverMultiScan (v6.0)
- K253934 — Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C)
- K253960 — Medicell Mycosis Laser (MCML24004)
- K254032 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V
- K260069 — DePuy Synthes VOLT Proximal Tibia 3.5 Plating System
- K260355 — Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup
- K260405 — FiberTape Button
- K253668 — Onera SleepMap (SLEEPMAP)
- K251807 — Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR
- K251818 — BONTREE PLUS
- K252208 — JFord Speculum Sleeve
- K253132 — Single use stone retrieval balloons
- K253262 — EmeryGlide (EG18008901)
- K253538 — TeKBrace Knotless Anchor
- K253551 — VELYS Hip Navigation
- K253772 — Velocity Alpha MR High Speed Surgical Drill System
- K253951 — Holmium Laser Therapeutic Apparatus (3 models)
- K253983 — Water-based lubricant
- K260013 — CVAC Image Processor
- K260166 — Bunkerhill Contrast CAC
- K260167 — Bunkerhill Contrast AVC
- K260361 — Treace Medical Concepts (TMC) Screw Fixation System
- K251788 — Extension tube
- K251901 — Magnifico Open (100009900)
- K252196 — Arthrex FibuLock Nail System
- K252450 — Adhese 2
- K252538 — CEPHX3D
- K252779 — YUWELL® Electronic Blood Pressure Monitor (YE630CR)
- K253267 — CORIS System
- K253442 — EarliPoint Assessment
- K253591 — Phantom® Hindfoot TTC/TC Nail System
- K260169 — AV Cardiac CT
- DEN250012 — LifeVac
- K251434 — Healing Abutment System
- K252025 — Active Intramedullary (AIM) Tibial Nail System
- K253493 — Dentis SQ-SL AXEL Fixture
- K253565 — SureSmile Software
- K253870 — Electric Wheelchair (MP148)
- K253871 — Klär Lite (RCW-KL1000)
- K253878 — LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)
- K253896 — TENS/EMS device (GUSE01)
- K253898 — QT Scanner 2000 Model A
- K254306 — Aevumed FENIX Suture Anchor
- K260015 — ANTERIS Thoracolumbar Plate System
- K260365 — Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module +5 more
- K260380 — Mendit
- K251793 — SOTA Cloud Smart Sensor (1.5)
- K251940 — PathLoc Lumbar Plate System
- K252534 — Surgical Face Mask (Ear mount)
- K253818 — Annalise Enterprise
- K253845 — Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)
- K253874 — LED Therapy Light (COB1400, HP1800PRO)
Data sourced from openFDA. This site is unofficial and independent of the FDA.