FDA 510(k) clearances — page 232
clearances on record, most recent first.
Clearances — page 232
23,101–23,200 of 176,542- K180968 — AlphaDent Implants Dental Implants System
- K182580 — Novidia Flowable Composite
- K182780 — XP Composite
- K183058 — Arm-type Electronic Blood Pressure Monitor
- K190272 — Bluephase PowerCure
- K190442 — Koios DS for Breast
- K190589 — Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments
- K190724 — MD-Temp Plus
- K190915 — OsteoFab Suture Anchors
- K190959 — ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology
- K191018 — Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors
- K191169 — NuVasive® Camber Laminoplasty System
- K191204 — Infinity Fixation System
- K191451 — CMDR 2CW (Multiple models)
- K191468 — syngo.CT Dual Energy
- K191495 — Biopsy Positioner
- K182876 — Uro-N Cystoscope
- K183138 — Certain BellaTek Express and BellaTek Flex Abutments
- K190351 — Site Seal SV
- K190617 — Wrap accessory electrodes
- K190634 — Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System
- K190687 — Twilite Appliance
- K191008 — iLab Polaris Multi-Modality Guidance System
- K191137 — 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500
- K191460 — PWD Platform Wound Dressing 3 x 5 Oblong
- K182847 — Hudson RCI Voldyne Volumetric Exerciser
- K183062 — ASAHI Silverway
- K183173 — LIGHTMED Ultrasound System
- K190166 — TriMed Nitinol Staple System
- K190524 — MRopen 0.5 T
- K190550 — IKON 40 Manual Wheelchair
- K190905 — BD Phoenix Automated Microbiology System GN Ceftaroline (0.0156-4 µg/mL)
- K190980 — Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter
- K181672 — SureTouch Mobile Pressure Mapping System
- K183021 — ClearEndoclip
- K183064 — TxTi IBF System
- K183389 — Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove
- K190101 — UltraFlex IAB
- K190251 — RecoveryRx
- K190341 — iC-GN iC-Cassette for use on the iC-System
- K190475 — Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4
- K190516 — MicroLink All-Suture Button Fixation System (Radiolucent)
- K190582 — MicroLink All-Suture Button Fixation System (Radiopaque)
- K190654 — Straumann CI RD Ceramic Healing Caps
- K190696 — Stryker Surgeon iD Mandible Recon Plate
- K191223 — NAVIO
- K191450 — Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System
- K191483 — HEALIX ADVANCE Anchor with DYNA+TAPE Sutures
- K182683 — Z-Robot Patient Positioning System
- K182733 — Rochal Bioshield Silicone Film
- K183183 — VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture
- K183602 — SwimCount Sperm Quality Test
- K190017 — LiverMultiScan (LMSv3)
- K190080 — Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)
- K190578 — SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence
- K190583 — DynaFlex
- K190782 — FlexGard Cut-Resistant Glove Liners
- K191175 — ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
- K191438 — ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector
- K191465 — Human IgM Kit for use on SPAPlus
- K182832 — Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set
- K182851 — SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
- K190096 — R2GATE
- K190097 — Straumann CARES Screw-Retained Bridges and Bars
- K190299 — Elos Accurate® Customized Abutment
- K190938 — Phototherapy System
- K191128 — Vantage Titan 3T, MRT-3010, V2.5
- K191166 — DigniCap Delta
- K191485 — Deflectable Brush Biopsy Set
- K182704 — WishBone Guided Growth System
- K190052 — Radio Frequency Ablation System
- K190743 — Venus Bliss
- K190779 — Trevo XP ProVue Retriever
- K190784 — BUHLMANN fCAL turbo
- K190785 — Reprocessed PentaRay Nav eco High-Density Mapping Catheter
- K191168 — Cepheid Xpert SA Nasal Complete Control Panel
- K191194 — CLARUS
- K191207 — Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System
- K171304 — Maxxi Rip Sensor
- K182411 — Scooter, Model: R-100
- K183032 — FUJIFILM Double Balloon Endoscope EI580BT
- K183170 — uWS-CT
- K190106 — Intra-Operative Positioning System +4 more
- K190443 — MMSphere
- K190927 — Oscillometric Blood Pressure Monitor
- K190754 — Orthoss(R)
- K182844 — ASAHI SASUKE
- K181260 — MiiS Horus Scope DPT 100
- K182139 — AXTi Titanium Stand-Alone ALIF System
- K182960 — ReliefBand
- K182963 — emFieldPro
- K183220 — OrthoScan TAU Mini C-Arm
- K183262 — EsoCheck CCD Cell Collection Device
- K183595 — Aqua Medical RF Vapor System
- K190130 — The ClearSight finger cuffs
- K190152 — Vit Kit- Freeze NX and Vit Kit- Warm NX
- K190360 — LineSider Spinal System
- K190597 — BRILLIANT EverGlow Flow
- K190750 — DePuy Synthes Plates and Screws Portfolio
- K191151 — JKH Stimulator Plus
Data sourced from openFDA. This site is unofficial and independent of the FDA.