FDA 510(k) clearances — page 89
clearances on record, most recent first.
Clearances — page 89
8,801–8,900 of 175,620- K231579 — MOLLI 2
- K231595 — Electric Breast Pump
- K231685 — TE Air Diagnostic Ultrasound System
- K231737 — ANAX 5.5 Spinal System
- K232271 — SIMDA abutment
- K232500 — Lumify Diagnostic Ultrasound System
- K233091 — Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)
- K233101 — Luja Coude (20108 Male CH18 - large packaging)
- K233170 — cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)
- K233223 — OGmend® Implant Enhancement System
- K233234 — PressON Spinal Fixation System
- K233417 — AllTest Fentanyl Urine Test Cassette
- K221315 — UNIdental Symphony Implant System
- K221615 — Newclip Patient-matched instrumentation non sterile PSI
- K222997 — VVR Generator system
- K230284 — Penumbra LP Coil System
- K230511 — K3900 Ultrasound Imaging System
- K230645 — BeneHold Surgical Incise Drape with CHG antimicrobial II
- K230842 — SignalHF (IM008)
- K231069 — PERLA® TL Posterior Thoraco-lumbar Fixation System
- K231327 — POWERSEAL Sealer and Divider
- K231995 — AcuityUDR
- K232235 — Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro
- K232436 — Rapid SDH
- K233093 — Balanced Knee® System TriMax PS Plus Tibial Insert
- K233113 — ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)
- K233147 — PiXel8-RF
- K233210 — sam CS Long Duration Ultrasound Device
- K230472 — Sonopuls 190
- K230919 — Acumen IQ finger cuff
- K231509 — Aco Apache Ultrasound System
- K232051 — VISULAS green
- K232086 — spineEOS
- K232211 — REUNION Sacroiliac Joint Fusion System
- K232223 — PlaDuo System
- K232356 — Laser Cap, Model: Hat-01
- K232570 — Steerant Super Stiff Guidewire
- K232584 — Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter
- K232586 — Rexious Spinal Fixation System, Statera Spinal System, Statera-M Spinal System
- K232638 — FilteredFlo Warming Blankets
- K232683 — Knotilus+ PEEK Knotless Anchor
- K233185 — MODEL P8400 Controller for C2DXs Hemostatix Thermal Scalpel System
- K233348 — 16 Breast Coil
- K230281 — PICOCLAMP
- K230893 — Swiss LthoClast Trilogy
- K231560 — MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit
- K231732 — CleanSeal Advanced Bipolar Vessel Sealer Maryland
- K231764 — Ultrasound System 1300
- K232143 — Applanation Tonometer HT-5000
- K232201 — VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin
- K232205 — Vesco Q Enteral Feeding Pump; Vesco Q 500mL Bag Feed Set; Vesco Q 1000mL Bag Feed Set; Vesco Q 40mm Screw Cap Feed Set; Vesco Q ENPlus Feed Set
- K232305 — AI-Rad Companion Brain MR
- K232561 — Ripley Spinal Screw System by SAGICO
- K233258 — Shadow Knotless All-Suture Anchors
- K232091 — JO Coconut Hybrid Cooling Personal Lubricant
- K231539 — pRESET LITE Thrombectomy Device
- K223557 — SPECTRALIS HRA+OCT and variants
- K223909 — R2GATE Lite TM
- K230209 — Sonix Health
- K230983 — Unicare (K-UNICARE-USA)
- K230998 — Digital Wireless Intraoral X-Ray Sensor
- K231388 — NextDent Base
- K231578 — Lucitone Digital Print Denture System
- K231809 — Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement
- K231902 — GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090)
- K232042 — NexPort Trocar System (TS211001); NexPort Trocar System (TS211002); NexPort Trocar System (TS211003); NexPort Trocar System (TS211010); NexPort Trocar System (TS211011); NexPort Trocar System (TS211012); NexPort Trocar System (TS221001); NexPort Trocar System (TS221002); NexPort Trocar System (TS221003); NexPort Trocar System (TS221010); NexPort Trocar System (TS221011); NexPort Trocar System (TS221012); NexPort Trocar System (TS221020); NexPort Trocar System (TS221021);
- K232236 — Echo
- K232550 — Nitrile Examination Gloves, Dual Color Black-Blue
- K232552 — TuxDeluxe (Size 1 6100B, Size 2 6101B)
- K232922 — Pure-Vu EVS System
- K232951 — BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134)
- K233065 — V-PRO maX 2 Low Temperature Sterilization System
- K230178 — EasyOne Sky Spirometer
- K230459 — C.C. Life 21
- K230476 — Oran Park Mask
- K230478 — Acro Composites Interbody System
- K231381 — Xpert Xpress MVP; GeneXpert Xpress System
- K231664 — IRRAflow Active Fluid Exchange System (AFES)
- K231704 — Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System
- K231749 — Radio Frequency System
- K231976 — StealthStation Cranial Software, v3.1.5 (9735585)
- K232371 — Actinia® hip stems
- K232484 — KeyLift Expandable Interlaminar Stabilization System
- K232905 — Medline UNITE® REFLEX® Nitinol Staple Kit
- K232910 — CombiDiagnost R90
- K230199 — Byte Aligner System
- K230702 — Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)
- K230951 — Terumo Injection Filter Needle (NF-3013RBKE05M)
- K231225 — EConsole1
- K231395 — INNO SLA Submerged Narrow Implant System
- K231781 — OptiMesh Multiplanar Expandable Interbody Fusion System
- K231824 — SmartBolus Calculator
- K231826 — Omnipod 5 ACE Pump
- K231907 — Medline Safety Insulin and TB Syringes
- K232123 — MectaLIF Anterior Lag Extension
- K232524 — Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
- K232897 — Arthrex Small External Fixation System
- K232924 — T-Line® Hernia Mesh
- K222214 — ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
- K223911 — Lumen 155-SF
Data sourced from openFDA. This site is unofficial and independent of the FDA.