FDA 510(k) clearances — page 13
clearances on record, most recent first.
Clearances — page 13
1,201–1,300 of 175,620- K260546 — Q Pedicle Instruments
- K260632 — LASER THERMAL THERAPY KIT
- K252122 — DCwire Micro-guidewire
- K252282 — SurgiCount+ System
- K252433 — Sonio Detect (v3)
- K253334 — ZENEX Implant System_Short (R-System)
- K253395 — Stealth AXiS ENT clinical application
- K253447 — Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)
- K253590 — Millipede System
- K253705 — Healgen® Accurate Oral Fluid Drug Test
- K253838 — Lifemotion Disposable Membrane Oxygenator
- K253916 — APTUS Shoulder Proximal Humerus System, PentaLock 3.5
- K253944 — Data Analysis Facilitation Suite (DAFS)
- K254045 — CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System
- K254079 — LED Light Therapy Mask (Models: T2, RLD10)
- K254176 — SINEFIX
- K260511 — Ulike Reglow Light Therapy Device (UM10)
- K253581 — Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005)
- K251848 — Pentacam® Cornea OCT
- K251916 — GenBody COVID-19 Ag Home Test
- K251999 — Promogran Prisma Collagen Matrix with ORC and Silver
- K252040 — BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes
- K252249 — Extremity CT Imaging System
- K252261 — InferCare RECIST
- K252385 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses
- K252648 — Niti-S SPAXUS Stent
- K252923 — IASIS i2 Relaxation Neurofeedback System
- K253111 — Aeka Imaging
- K253205 — OptiMap Catheter - 50mm (OPTI-CATH2-50)
- K253261 — Apollo Quattro (APQ-10M)
- K253391 — Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)
- K253732 — Permatage Flowable, Settable Bone Paste
- K253799 — SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)
- K253987 — BARE Wireguided Balloon Dilation Catheter (1235)
- K254059 — Access anti-HBc IgM
- K254277 — Embrace Neonatal MRI System
- K260078 — Aquilion ServeSP (TSX-307B) V2.0
- K260147 — Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)
- K260455 — New Wave System
- K260479 — TheraSphere 360 Y-90 Management Platform
- K260499 — Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80
- K240934 — Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);
- 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; QIAstat-Dx GI Panel 2 Mini B
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.