FDA 510(k) clearances — page 137
clearances on record, most recent first.
Clearances — page 137
13,601–13,700 of 176,479- K222257 — 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil
- K222274 — FONA XDC
- K201730 — Powered Inflatable Tube Massager - SLIM UP DRAIN
- K211601 — Powder Free Latex Examination Glove, Non-Sterile
- K212095 — SurGuard3 Safety Hypodermic Needle
- K213109 — Auxilock Draw Tight Suture-Based Anchor
- K220363 — VPS Rhythm DLX Device with TipTracker Technology
- K220582 — ClearCalc Model RADCA V2
- K221485 — Arthrex FiberTape and TigerTape Cerclage Sutures
- K221528 — Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter
- K221599 — HS40 Diagnostic Ultrasound System
- K221604 — SafetiHeel, MediHeel, Novaplus
- K221832 — SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter
- K221835 — CUSA Clarity Ultrasonic Surgical Aspirator System
- K203078 — CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW
- K212525 — Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices
- K212554 — Bonvadis Topical Cream
- K213520 — AXIR-CX
- K213758 — Lexa PLUS RIS-311
- K213933 — Percent Oxygen Sensors
- K220016 — Viramed Borrela All-In-One ViraChip Test Kit
- K220193 — BD MAX Enteric Parasite Panel
- K220292 — Disposable Endoscope Injection Needle
- K220394 — SmartAdjust(TM) technology
- K220696 — uCerv Flux-C 3D Porous Titanium Cervical Interbody
- K220812 — DynaClip® Bone Staple
- K221023 — Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5
- K221224 — REAL INTELLIGENCE CORI
- K221238 — FUJIFILM Ultrasonic Endoscope EG-740UT
- K221403 — Cortera Spinal Fixation System
- K221824 — OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpClear Disposable Procedure Kits (CS-10-00-300, CS-10-30-300, CS-10-00-315, CS-10-30-315, CS-10-00-330, CS-10-30-330, CS-05-00-290, CS-05-30-290), Contd from 3 above: CS-05-00-300, CS-05-30-300, CS-05-00-315, CS-05-30-315
- K221848 — prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments
- K221917 — Stent Positioning Assistance System (SPAS)
- K222130 — 1688 4K Camera System with Advanced Imaging Modality
- K222172 — MI View&GO
- K222194 — Baby Gorilla®/Gorilla® Plating System
- K222239 — SmartBolus Calculator
- K210797 — Bio-MEM Ti Reinforced Membrane
- K212518 — Jeesung Safety Syringe and Single Use Needles
- K212856 — iClean Viral Transport System (VTM-RT kit)
- K212905 — Sotair Device
- K213390 — Benchmark BMX96 Access System
- K220647 — GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273)
- K220959 — OR3O Dual Mobility System
- K221213 — EnSite X EP System
- K221353 — Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VS
- K221520 — Miro3D Wound Matrix
- K222272 — truFreeze Console, PN CC301 +6 more
- K210678 — implaFit® hip stems
- K212033 — Disposable Sterile Syringe, with/without needle +1 more
- K212273 — Cross Protection ResQ300 Plus Surgical Face Mask
- K220387 — Disposable Blood Lancets
- K220452 — Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner
- K220530 — Tetragraph Neuromuscular Transmission Monitor
- K220897 — Disposable Brain Biopsy Needle 2.0
- K220903 — WebCeph
- K221112 — CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)
- K221838 — Surgical Face Mask (HNFM0103)
- K221844 — TDM Lumbar Interbody Fusion Cage System
- K212385 — YUWELL Finger Pulse Oximeter
- K213026 — Clear Aligner
- K213426 — HemosIL ReadiPlasTin
- K213937 — Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution
- K220329 — G-CAM
- K220433 — syngo Application Software (VE21)
- K221190 — ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System
- K221852 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter
- K222169 — FairFix Adjustable Button System
- K212790 — XLase Plus
- K213527 — FORUM
- K213845 — HeRO Graft
- K214095 — da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments
- K220163 — Her-2, ER, PR IHControls
- K221302 — Recon Steerable Sheath
- K202461 — ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System
- K202508 — Hemo-Lyte C Cartridge
- K202739 — Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System
- K213686 — SKOUT Software
- K220090 — Visibly Digital Acuity Product
- K220349 — TeraRecon Neuro
- K220385 — Intense Pulsed Light Equipment
- K220403 — Vibe SF Self-Fitting Hearing Aid
- K220434 — Blue Eye (TS-905)
- K220680 — Denture Base Polymers
- K220835 — Arkligners
- K221027 — Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))
- K221049 — Zavation VariSync Plate System and VariSync Spacer System
- K221126 — Unistik® 3, sterile single-use safety lancets +2 more
- K221131 — Tasso+
- K221466 — IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17
- K222082 — aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices
- K222145 — EzDent-i / E2 / Prora View/ Smart M Viewer
- K210949 — Foundation Dermal Regeneration Scaffold (DRS) Solo
- K212361 — Novo
- K213713 — AI-Rad Companion (Pulmonary)
- K220050 — KLS Martin IPS Distraction
- K220308 — Patient Monitor: RespArray
- K220472 — NEUWAVE Microwave Ablation System and Accessories
- K220648 — OMF ASP System
- K220731 — Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem
Data sourced from openFDA. This site is unofficial and independent of the FDA.