FDA 510(k) clearances — page 70
clearances on record, most recent first.
Clearances — page 70
6,901–7,000 of 176,479- K241582 — Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)
- K241695 — Extremity All Suture System
- K241710 — 3M Attest Super Rapid Readout Biological Indicator 1492V +3 more
- K242136 — Electric wheelchair (C001)
- K242401 — EXULT Knee Replacement System
- K232559 — C&B NFH Hybrid
- K240271 — Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
- K240683 — Rx Knee System
- K241004 — Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2)
- K241010 — HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors
- K241161 — Ultrasound Imaging System (13+ models)
- K241362 — Pounce XL Thrombectomy System (PTS-1011-7F135)
- K241380 — FETOLY-HEART
- K241438 — Signus Tetris St; Signus Tetris R St
- K241745 — Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue)
- K241954 — SonoBlock; SonoBlock II
- K234064 — Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936) +1 more
- K240094 — LumiNE US
- K240990 — Mobility Scooter
- K241214 — ProPel SG3 Surgical Gown
- K241609 — Tornier Humeral Reconstruction System (Tornier HRS)
- K241638 — 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads
- K242612 — Option ELITE Vena Cava Filter System (352506070E 352506100E)
- K240233 — Pitkar Spinal Pedicle Screw System
- K240266 — Latex Examination Glove Powder Free (Ocean Blue and Natural White)
- K240697 — See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
- K240791 — ADAS 3D
- K241205 — Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE)
- K241678 — TENS & EMS Stimulator (MHD-1083)
- K241681 — Overjet Image Enhancement Assist
- K242042 — TriALTIS Spine System
- K242349 — FoLix
- K242394 — Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)
- K240486 — PM2 System and ECGuide Connector
- K231667 — Withings Sleep Rx
- K232543 — MSC SFM
- K232996 — Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)
- K233806 — T2 Plus
- K233900 — Nordica PV Cryo Mapping Catheter
- K233911 — VISULAS combi
- K233921 — Luvis Chair (LC700C)
- K233974 — Mucosal Impedance Measurement System
- K234035 — COSINE Spacer
- K234044 — ACS® LD FB Knee System
- K240411 — uAI Portal
- K240600 — SafeCross Vascular Introducer System (4001)
- K241164 — IB3D PL Spinal System
- K241415 — Orchid Safety Release Valve
- K241427 — Access Syphilis
- K241552 — MENTOR MemoryGel Enhance Single Use Gel Sizer
- K241579 — DD Hybridlayer (multicolored zirconia)
- K241672 — COPRO 3
- K241693 — FemChec Controlled Saline-Air Device (FCD-250)
- K241976 — nextaro® va, 15mm, 5µm
- K242415 — TMC Compression Implant System
- K231566 — ICX-Implant System
- K231741 — ProGear® Surgical Mask with Oxafence®, Model AV82030
- K232692 — Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)
- K233998 — TRAQinform IQ
- K240203 — URUS System (3 models)
- K241155 — Cold Sore Device (QPZ-03)
- K241356 — Fine Osteotomy
- K241605 — Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System with Nanotechnology
- K241721 — Electric wheelchair (N3901)
- K241723 — Electric wheelchair (W3902)
- K242390 — Novum IQ Syringe Pump (40800BAXUS)
- K221275 — Qraycam PRO
- K231095 — Tamper Evident Cap
- K231502 — Mini Screws
- K233977 — Velacur
- K240142 — FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP
- K240158 — Modular Medical MODD1 Insulin Delivery System
- K240646 — DreamClear
- K241071 — NextDent Jet Denture Base; NextDent Jet Denture Teeth
- K242305 — BE Plus PRO, Neurotravel LIGHT
- K242306 — SignalNED System (Model RE)
- K233805 — K5
- K240487 — EVOS Patella Plates
- K241295 — SOMATOM On.site
- K241611 — ShapeIT (SI014135)
- K242069 — Eminent Spine Scoliosis Deformity Pedicle Screw System
- K242251 — Litho 60; Litho 100; Litho 150
- K242319 — Indigo® Aspiration System Aspiration Catheter 6X
- K241592 — Arthrex VAL and VAL KreuLock Compression Screw System
- K231969 — BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808)
- K232441 — Unipro (K-UNIPRO-US)
- K233107 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5
- K233872 — Daylight
- K233932 — Alinity i Toxo IgM
- K234027 — embecta Insulin Delivery System
- K240003 — Velmeni for Dentists (V4D)
- K240180 — Orthopeasia Spinal Fixation System
- K240464 — WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV
- K241051 — Vave Wireless Ultrasound System
- K241148 — Salto Talaris Ankle PSI System
- K241256 — JetBoots PRO Plus
- K241318 — Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)
- K241326 — Cadence Ankle PSI System
- K241386 — Heyman Packing Applicator Set (GM11004580)
- K241393 — ODI-Tech
Data sourced from openFDA. This site is unofficial and independent of the FDA.