FDA 510(k) clearances — page 12
clearances on record, most recent first.
Clearances — page 12
1,101–1,200 of 176,428- K253121 — Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle
- K253151 — Fule Interbody Fusion Cage System
- K253172 — MediAI-OA
- K253690 — LungMaps
- K253825 — Saige-Dx
- K253922 — Neodent Scannable Healing Abutment
- K260036 — NeckTune 3D SA Cervical Cage
- K260126 — Curajel Oral Gel
- K260286 — Dynamo Spinal Cement; Salvo® Spine System
- K260300 — WatchMate Software
- K260333 — LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit
- K260335 — Electric Wheelchair (S500-6)
- K260452 — Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158)
- K260482 — DRE Duo
- K260885 — VERAFEYE Imaging and Guidance System (VF-VIS-002)
- K261265 — Permatage XT Settable Bone Putty
- K261604 — Enobio Dx (3 models)
- K252171 — Barbed PDO Suture
- K252323 — cobas pulse blood glucose monitoring system
- K252932 — Fast PCR Mini Respiratory Panel
- K252933 — DYNE PORT
- K252937 — ThinkQA 3
- K252963 — BTL-899TT
- K252987 — ADRx Admixture Device
- K252996 — Universal 1417PI
- K253015 — Cognitive Function Neuroimaging (cfNI) Software (1.0.0)
- K253088 — OneStim-DUO Cardiac Stimulator (MP5003-4CO)
- K253196 — Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)
- K253437 — Spiro-VISTA
- K253688 — MEDRAD® Imaging Bulk Package Transfer Spike
- K260102 — Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System
- K260346 — Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)
- K260406 — Brainomix 360 Hyperdensity
- K260514 — Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle
- K260635 — HARBOR Occlusion Device
- K260935 — Stelo Glucose Biosensor System
- K261175 — WHILL (WHILL Model C2)
- K261204 — Intense Pulsed Light Therapy Device
- K261207 — Exalta Proximal Tibia Plating System
- K261213 — Medical Monitor (40HT513D)
- K261366 — Virtus
- K261634 — Disposable Blood Lancet (Soft)
- K250129 — AViTA Breast Pump
- K250839 — Dental X-ray System
- K251326 — Respiration Rate algorithm
- K253051 — i-STAT hs-TnI cartridge with the i-STAT Alinity System
- K253052 — Fluoride Varnish (Type A,Type C)
- K253607 — UNEEG EpiSight System
- K253650 — Anura Mobile Core SDK (M1)
- K254087 — MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System
- K254145 — Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut)
- K260174 — PROBEAT-CR
- K260322 — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
- K260653 — Dexter L6 System
- K260710 — FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)
- K260849 — ICON 35; ICON 45; ICON 60; ICON 30FAF
- K260859 — Rosetta SM, Rosetta SP
- K261209 — Ion-L
- K261251 — Snorbliss® Anti-Snoring Device
- K261256 — Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)
- K261292 — PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)
- K261610 — Verge Microcatheter
- K250690 — Penumbra System (Thunderbolt Aspiration Tubing)
- K253115 — LARS ACJ
- K253192 — DeepXray Spina
- K253919 — Cryo And Thermo Therapy System
- K254121 — Colli-PeeDx Urine Collection Kit
- K260414 — Tech-Image Video Endoscope System
- K260614 — Tinnitus Therapy
- K260810 — Anteralign LS coverplate
- K260855 — Profoject Safety Pen Needles
- K261016 — MSS - Humeral reverse liners extension
- K261174 — RxSight® Insertion Device
- K261329 — Intra-Operative Positioning System (IOPS) (MC-1) +7 more
- K251251 — ChanPin Pedicle Screw Spinal System
- K252914 — Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)
- K253165 — LAP-iX2N
- K260564 — DESS Dental Smart Solutions
- K260748 — ES-Series
- K260802 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
- K260864 — Mother's Nature W1 Warming Wearable Breast Pump
- K261549 — BOBBY Balloon Guide Catheter
- K261621 — TekBrace Solo Soft Tissue Reinforcement Device
- K261806 — ERBECRYO 2 Cryosurgical Unit and Accessories
- K251944 — Lipocosm Harmonic System
- K253066 — ELEOS with NanoCept® Technology Limb Salvage System
- K253257 — Virgo Mobility Scooter (Virgo-D,Virgo-F)
- K253542 — Apollo Quattro (APQ-10M)
- K260332 — EchoNext
- K261352 — 2D Hip Planning Software
- K261402 — Dexcom G7 Continuous Glucose Monitoring System; Dexcom G7 15 Day Continuous Glucose Monitoring System
- K243192 — iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating
- K251684 — Alma TED+ System
- K253108 — VEOFIX Snap Off Screw
- K253162 — Temperature probes (5 models)
- K253204 — Catalyze
- K253296 — Digital C-ARM with 3D
- K253656 — OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System
- K254086 — EyeBOX SNAP
- K260056 — Power Wheelchair (N5515A, N5516, N5517A, N5519)
Data sourced from openFDA. This site is unofficial and independent of the FDA.