FDA 510(k) clearances — page 124
clearances on record, most recent first.
Clearances — page 124
12,301–12,400 of 175,620- K213969 — VisionAir Patient-Specific Airway Stent
- K220057 — Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization
- K220092 — YADU Surgical Gowns
- K220111 — RespiraSense
- K220156 — Electrically Powered Wheelchair, Joy Rider
- K220256 — MIM-Ablation
- K220267 — AMSafe NeuFlo Needleless Connector
- K220709 — BriefCase
- K221154 — Infant Heel WarmerTM; Heel Snuggler®
- K221170 — Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107
- K221310 — Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing
- K221492 — SteriTite Container System with MediTray Parts
- K221498 — Miha Bodytec II
- K221575 — Pre-Formed Blue
- K221764 — InBody Blood pressure monitor, Model BPBIO480KV
- K221818 — Rebellion; Phantom Multi-Bite Kerrison Rongeur
- K222028 — IdentiTi Porous Ti Interbody System, IdentiTi NanoTec Interbody System, Transcend PEEK Interbody System, Transcend NanoTec Interbody System, IdentiTi ALIF Standalone Interbody System, IdentiTi NanoTec ALIF Standalone Interbody System
- K222205 — Cold Sore Device (Model: QPZ-01)
- K222369 — PURE Laser
- K222418 — Nuvola
- K222424 — Protect-It Custom Fit Dental Guard
- K222698 — CUVIS-spine
- K222714 — Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs
- K211892 — ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)
- K212168 — A&D Medical UM-212BLE Blood Pressure Monitor
- K213666 — NuCath Wedge Pressure Catheter
- K220365 — Gemini Sterilization Wrap
- K220852 — iCare IC200
- K221449 — Genius AI Detection 2.0
- K221653 — InfaTherm Disposable Infant Warming Mattress
- K221889 — ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring
- K222080 — Garion Image-Intensified Fluoroscopic X-Ray System, Mobile
- K222427 — PRIMA TT Glenoid
- K222431 — b-ONER MOBIO Total Knee System
- K222686 — Perfit FS Dental Zirconia Fully Sintered Block
- K222700 — Tibial baseplate, Tibial insert
- K212779 — Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing
- K220138 — Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP
- K220140 — ClearCorrect System
- K220546 — Colibrí System
- K221128 — Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II
- K221759 — Cornisol
- K221892 — VISIONAIR
- K222515 — FaSet Fixation System
- K222737 — Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)
- K213464 — HemosIL Liquid Anti-Xa
- K220683 — INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)
- K221066 — Sterile Hypodermic Needles for Single Use
- K221068 — Sterile Hypodermic Syringes for Single Use with Needles
- K221073 — Sterile Hypodermic Syringes for Single Use with Safety Needles
- K221079 — Sterile Hypodermic Syringes for Single Use
- K221080 — Sterile Safety Hypodermic Needles for Single Use
- K221517 — POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens
- K221646 — CD HORIZON ASTUTE SPINAL SYSTEM; CD HORIZON Growth Rod Conversion Set; CD HORIZON SPINAL SYSTEM; CD Horizon Fenestrated Screw Set; COLORADO 2 SPINAL System; GDLH POSTERIOR SPINAL SYSTEM; SHILLA Growth Guidance System; TENOR SPINAL SYSTEM
- K221928 — ROSA® Knee System
- K221994 — Hailie Sensor NF0107 & NF0108
- K222380 — TriVerse Total Knee Replacement System
- K222743 — Route 92 Medical Full Length 070 Access System
- K201237 — Velano Vascular Blood Collection Adapter
- K202953 — Aurolase Therapy, Laser Delivery Device (LDD)
- K212262 — PCA Syringe Sets
- K213014 — Varixis Elbow System
- K213842 — ONVOY Acetabular System
- K220220 — Electronic Sphygmomanometer (Model: LT-P30)
- K221047 — SILO TFX MIS Sacroiliac Joint Fixation System
- K221613 — Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets
- K221778 — Disposable Safety Lancets
- K222267 — Arthrex 2.4 mm Volar Distal Radius Plate System
- K222354 — Elastic Traction System
- K222376 — Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)
- K222937 — Disposable Nitrile Examination Glove
- K200073 — AugMENTA Penile Implant
- K210478 — 8mm Monopolar Curved Scissors
- K210567 — Ultrasonic Surgical System
- K211611 — QIR Suite
- K212316 — DoubleChek DC-1001
- K213023 — Blood Pressure Monitor(Model:Y30001)
- K213904 — Kerecis Oral
- K220336 — Mg-PSZ Ceramic Femoral Head
- K220366 — EmbedMed
- K220758 — e-Ortho Shoulder Software v1.1
- K221003 — Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA
- K221243 — OFNat Lubricant (L15)
- K221378 — Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile
- K222046 — Unscented Menstrual Tampon
- K222090 — Safety Lancet
- K222206 — Air Compression Leg Massager (Models: S9036C, S9036B and S9036A)
- K222244 — Arthrex 3.5 mm Locking Compression Plates
- K222339 — uDR 380i Pro
- K222625 — Shield System
- K222849 — AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector
- DEN200067 — INNOVANCE VWF Ac
- K213034 — SpineAR SNAP
- K213126 — Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws
- K213417 — Ghost Spacer System
- K213716 — InnovaBurn
- K220080 — CogNet QmTRIAGE
- K221300 — Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System
- K221375 — CureSight-CS100
- K221496 — Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic Ultrasound System, Consona N6 Elite, Consona N6T Diagnostic Ultrasound System
Data sourced from openFDA. This site is unofficial and independent of the FDA.