FDA 510(k) clearances — page 130
clearances on record, most recent first.
Clearances — page 130
12,901–13,000 of 176,479- K221675 — United U2 femoral head, 22mm delta ceramic head
- K221822 — BENCHMARK BMX81 Access System
- K222049 — Yomi Robotic System
- K222124 — Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle
- K222453 — Self-adhesive Electrode
- K222639 — VHA Radiotherapy Bolus
- K222697 — Disposable Medical Face Mask (DF3-001)
- K223062 — World Total Knee System
- K223164 — Aquilo Sports CCT1500 System
- K220263 — Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers
- K220466 — ibiomedi Electronic Stethoscope ES-2020
- K221045 — Insulin Syringes without needle
- K221518 — NP Medical nCompass Extension Set with Stabilizing Base
- K221719 — ABTross ALIF Expandable Cage System
- K222107 — Black Diamond POCT Spinal System
- K222168 — Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler
- K222377 — Led Mask Platinum Md
- K223110 — truSculpt iD
- K223355 — Tera Harz Clear
- K211816 — Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K220371 — Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with the Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)
- K221184 — ORiGO System
- K222084 — OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie
- K222395 — Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo
- K223320 — Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K214090 — Back 3 COLOR
- K220539 — Klarity SRS Baseplate, Klarity Promise Baseplate
- K221247 — Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle
- K221478 — Dolphin Blue Imaging
- K222258 — Combined High Frequency X-ray Source
- K222508 — 3M Comply Hydrogen Peroxide Chemical Indicator 1248
- K222550 — Current Health System
- K223270 — POSE Health Care Surgical Mask
- K213697 — ORiGO System
- K220890 — IO Needle Safety Sheath
- K220929 — Excelsior
- K221810 — LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device
- K222085 — Standard Tapered Bougie, 38 Fr.
- K222318 — Fresenius Liberty Select Cycler
- K222717 — CL24N
- K222722 — CW60N
- K221064 — Nuheara IQbuds 2 PRO Hearing Aid
- K211060 — Disposable Surgical Gown Rk-3011C
- K212473 — Welch Allyn Connex Central Station
- K214109 — PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
- K220305 — Syntheon LAA Exclusion System, Syntheon LAA Selection Guide
- K220869 — Vapotherm Aerosol Adapter AAA-2
- K221406 — Vented Vial Transfer Pin
- K221435 — SUPERTILT PLUS (STP)
- K221521 — Disposable Safety Lancet
- K221667 — Non Sterile Powder Free Latex Examination Glove
- K222031 — Spinal Inner Fixation System
- K222191 — Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40
- K222581 — Stela Automix System
- K222583 — Stela Capsule System
- K222653 — JOURNEY II UK and ENGAGE Cementless Partial Knee System
- K223020 — VS3-Iridium System (VS3-IR)
- K223064 — ALLY II Uterine Positioning System (UPS)
- K223070 — Remi Robotic Navigation System
- K223079 — Stage
- K223098 — Bakri Essential Postpartum Balloon
- K212745 — ORAcollect®Dx
- K220332 — uMR Omega with uWS-MR-MRS
- K220880 — Arthrex BioSuture
- K220949 — Architect CMV IgG
- K221322 — CUSTMBITE Snoring System
- K221420 — AlphaID At Home Genetic Health Risk Service
- K221489 — Artemis Proximal Femoral Nail System
- K222231 — S.I.N. Dental Implant System
- K222282 — HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System
- K222288 — DESS Dental Smart Solutions
- K222348 — JR MEDIC
- K222505 — CurvaFix IM System
- K222514 — S.I.N. Instrument Kits
- K222601 — FilmArray Pneumonia Panel plus
- K222678 — Mobility+ Enteral Feeding System
- K222952 — 2008T BlueStar Hemodailysis Machine
- K222966 — Cirq Arm System (2.0); Alignment System Spine
- K213690 — Eclipse Blood Collection Set
- K220132 — FIREFLY® Cervical Navigation Guide
- K220823 — Preat Abutments
- K221218 — Silverlon Wound Contact, Burn Contact Dressings
- K221374 — Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)
- K221885 — 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
- K222032 — NEUROMARK System
- K222047 — Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)
- K222269 — DESS Dental Smart Solutions
- K222281 — Intracept Intraosseous Nerve Ablation System
- K222366 — EsoCheck Cell Collection Device
- K222498 — Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)
- K222631 — VASSALLO GT EXT
- K222807 — TEMA Elbow system - Line extension
- K223058 — EzRay Air 2 Wall (Model: VEX-S350W)
- K223060 — DigiX FDX
- K223065 — Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices
- K223235 — Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)
- K212649 — Disposable Surgical Face Mask
- K220565 — Hudson RCI Triflo II Incentive Deep Breathing Exerciser
- K221169 — JR MEDIC Nitrile Examination Gloves Powder Free- Black
- K222070 — EndoNaut
Data sourced from openFDA. This site is unofficial and independent of the FDA.