FDA 510(k) clearances — page 101
clearances on record, most recent first.
Clearances — page 101
10,001–10,100 of 175,620- K223048 — Medisystem Pacs
- K223159 — Radixact Treatment Delivery System
- K223187 — HemosIL Liquid Anti-Xa
- K223638 — Neodent Implant System - Helix Short Implant System
- K230036 — Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )
- K230160 — VINNO G86,VINNO G86E,VINNO G65,VINNO G65P,VINNO G65E,VINNO G65D,VINNO M86, VINNO M86E,VINNO G90,VINNO G90E
- K230276 — TECHFIT DISRP® System
- K230359 — KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-
- K230369 — EUROPA Navigated Instruments
- K230410 — DD medical polymers (PMMA)
- K230518 — HydraDose Vaginal Suppositories
- K230774 — PERLA® TL System; TEKTONA® HV US Bone Cement
- K231117 — neXus Ultrasonic Surgical Aspirator System
- K231153 — Neuhat Hair Growth System; ibeauty.com Laser Cap
- K231185 — MapRT
- K231505 — GORE® ACUSEAL Vascular Graft
- K231532 — ActiGraph LEAP activity monitor (ActiGraph LEAP)
- K222932 — INVOcell Intravaginal Culture System
- K223083 — Straumann SLActive labeling changes
- K223379 — Portable Oxygen Concentrator (Model: P2-E7, P2-E)
- K223558 — CUVIS-spine
- K223741 — Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300)
- K223871 — Miria Skin Treatment System
- K230322 — SelectFlex Neurovascular Access System Family
- K230444 — Talee, Talee PostOp
- K230497 — Bladder AI (AIBV01)
- K230599 — TargetCool
- K230904 — Arthrex Virtual Implant Positioning (VIP) System
- K231131 — Diode Laser Body Sculpture Systems
- K231202 — QuickRayPRO
- K221311 — Antibacterial Bandage
- K222658 — Accurate 24 Non-invasive blood pressure monitor
- K223033 — Tixel® 2 System
- K223248 — Tablo® Hemodialysis System
- K223376 — Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)
- K230309 — Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1)
- K230506 — PureLift Pro Edition
- K230886 — Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
- K231031 — ACL TOP Family 70 Series
- K231212 — da Vinci E-200 Electrosurgical Generator
- K231467 — 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF
- K231469 — PAXgene® Blood DNA Tube
- K231485 — iLet® ACE Pump
- K231489 — Sturdy Autoclave Super Microm
- K231533 — Habib EndoHPB
- K221024 — tremoflo C2 Airwave Oscillometry System
- K222998 — F3
- K223029 — Perfit CL
- K223103 — BethaLoc® stem cementless HA
- K223522 — NC° Thermometer (Gen 3), Model Number: NCTG3
- K223535 — SMARTbase Abutment System
- K230346 — Voluson SWIFT; Voluson SWIFT+
- K230781 — Belle Sensilube
- K230796 — Sparrow Ascent
- K230993 — CODA Anterior Cervical Plate System
- K231075 — Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)
- K231148 — ScleroSafe 150 mm, ScleroSafe 350 mm
- K231459 — HepaFatSmart (V2.0.0)
- K220072 — Sinobot X1
- K223917 — VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2P
- K223920 — VINNO G50, VINNO G55, VINNO M50, VINNO E30, VINNO X5, VINNO X6, VINNO X7, VINNO M55, VINNO E35, VINNO X65, VINNO X55, VINNO X35, VINNO G55E, VINNO G55P, VINNO M55E, VINNO M55P, VINNO E35E, VINNO E35P
- DEN220048 — Neoasis
- K220107 — Mindray SV600 Ventilator, Mindray SV800 Ventilator
- K220703 — F&P 950 Respiratory Humidifier
- K220907 — The iNAP One Sleep Therapy System
- K221121 — Volumat Polyethylene I.V. Administration Set
- K222597 — BabySat 3
- K222906 — Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421
- K222999 — Surgical Gown
- K223217 — Zynex Monitoring System, Model CM-1600
- K223357 — EyeArt v2.2.0
- K223556 — DeepCatch
- K223646 — IB Lab LAMA
- K223890 — NAJA Gastrointestinal Catheter
- K230015 — OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver
- K230421 — SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash
- K230514 — Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series
- K230538 — All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid
- K230894 — NuVasive Modulus ALIF System
- K230910 — NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens
- K230965 — Acuity 100 (hexafocon A) with Tangible Hydra-PEG®, TYRO-97 (hofocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lens
- K231045 — Healgen URS Test Strips
- K231110 — Manual Wheelchair (A006)
- K231136 — Fitness Belt (Model: KLT-07)
- K231199 — Solar Lumbar Interbody Fusion System
- K231461 — Smart Correction System (HA Half Pins)
- K222861 — EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100
- K223258 — TNI Clear-Guard 3 angled breathing filter (1545020)
- K223469 — WallFlex Biliary RX Stent System
- K223715 — Celerity Incubator
- K223717 — Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack
- K230386 — SpassageQ
- K230473 — IPL Hair Removal Device Models: MLY-T069
- K230718 — UTC 3mL Medication Cartridge
- K230762 — EDEN Spinal Fixation MIS System
- K231023 — ERBEJET® 2 System
- K231090 — Zevo Anterior Cervical Plate System
- K231109 — Xerxes Hip Stem
- K221540 — Synexis Sphere Rx
- K222144 — IR SLA Type Implant System
Data sourced from openFDA. This site is unofficial and independent of the FDA.