FDA 510(k) clearances — page 140
clearances on record, most recent first.
Clearances — page 140
13,901–14,000 of 176,479- K212883 — ers2 - ergoline Rehabilitation System
- K213576 — Tatum Surgical Dental Implant System
- K213872 — ComPAS2
- K213997 — Kontact Dental Implant System
- K220127 — NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
- K220619 — Vivid S60N, Vivid S70N
- K220622 — Hailie Sensor NF0106
- K220631 — NomadAir PMU810
- K220742 — NxtGen Infant Transport Incubator
- K220877 — Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems
- K220970 — Renuvion APR Handpiece
- K221030 — Model 9100 PFT/DICO
- K221433 — Facet 28G Universal Lancet
- K221763 — CUSA Clarity Ultrasonic Surgical Aspirator System
- K221814 — OK Handpiece
- K221876 — Digital Radiography CXDI-Pro, Digital Radiography D1
- K203013 — AGNES
- K212073 — Alma Diode Tabletop Laser
- K213498 — PELNAC Meshed Bilayer Wound Matrix
- K213936 — LIAISON MeMed BV, LIAISON MeMed BV Control Set
- K213961 — TruAbutment DS, TruBase
- K214017 — Examination gloves-Type A(Latex gloves)
- K220040 — CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems
- K220204 — Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle
- K220258 — 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000)
- K220348 — Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V
- K220560 — Dermatac Drape
- K220862 — E-GPS Navigated Instruments
- K221097 — SmileSeries
- K221203 — AHI System
- K221429 — KDF Zirconia Disc
- K221431 — TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant
- K221666 — Normatec Go
- K210354 — SNUCONE Bone Level Implant System
- K221407 — truSculpt iD
- K221434 — 17HQ701G-B
- K221727 — syngo.CT Extended Functionality
- DEN210045 — APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System
- K203279 — Veuron-Brain-mN1
- K213143 — Hemoclip
- K213574 — Nitrile Vinyl Blend Powder Free Examination Gloves (Black)
- K213799 — N Series Patient Monitors
- K213899 — VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin
- K220415 — Protrieve Sheath
- K220814 — NAEOTOM Alpha, Scan&GO Software
- K221083 — Smartlux Mini
- K221098 — Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit
- K221108 — Nitrile Medical Examination Gloves
- K221454 — Disposable Medical Nitrile Examination Gloves - Non Sterile
- K220095 — ANNE Sleep
- K220480 — Revogene
- K220538 — DolorClast Radial
- K221364 — Mitek TIGHT-N Anchor
- K221846 — Artix Ballon Guiding Sheath
- K213405 — MINE ALNU (Model: Mine 2.1)
- K220573 — Noodle
- K201440 — ROTEM sigma Thromboelastometry System
- K210228 — KLS Martin IPS Preprosthetic
- K210793 — VIDAS NEPHROCHECK
- K212775 — Adin Short Implants
- K212783 — ProstatID
- K213009 — Transcranial Doppler Ultrasound System
- K213782 — Single-Use Video Bronchoscopes, Digital Controller
- K220284 — Powder Free Nitrile Examination Gloves (Blue)
- K220424 — Through the Scope Tracheal Stent System
- K220643 — DropSafe Acti-Lance Safety Lancets +3 more
- K220825 — Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves
- K221051 — Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
- K221346 — Stryker VariAx 2 MIS Calcaneus
- K221399 — ZIP MIS Interspinous Fusion System
- K212472 — AgeJet
- K213056 — LED Facial Mask
- K213387 — AltiVate® Anatomic Shoulder AG e+ with Markers
- K213873 — SkyWalker Total Knee System
- K220534 — Wet Essential95 Personal Lubricant
- K220771 — Stratasys TrueDent
- K221246 — IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)
- K221293 — E-Brik Visualization Assistant
- K221654 — medi pneumatic compression system (pcs)-genius (Model 652)
- K221679 — IPL Hair Remover, Model: G993, G996, G998 and G885
- K210069 — Minuteful - kidney test
- K212815 — My3D® Personalized Pelvic Reconstruction
- K212819 — Disposable Biopsy Refill Needle
- K212820 — Disposable Semi Automatic Biopsy Instrument
- K212822 — Disposable Coaxial Biopsy Needle
- K213007 — Cerebra Sleep System
- K213822 — cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System
- K214038 — Oscar Peripheral Multifunctional Catheter system
- K220024 — ChoiceSpine Navigation System
- K220475 — Lancet (I, II, III, V, VI) +1 more
- K221028 — SURGIVISIO Device
- K221033 — UniPrime A, UniPrime E, UniPrime E/C
- K221173 — Surgical Mask (Model: 0868F, 0866F)
- K221426 — Functional MR V1.0
- K213360 — SleepCheckRx
- K220743 — CediTEC
- K220827 — Electric Wheelchair
- K221019 — Osteon Precision Milled Suprastructure
- K221337 — Materialise TKA Guide System
- K203134 — Hanger Cranial Band 3D
Data sourced from openFDA. This site is unofficial and independent of the FDA.