FDA 510(k) clearances — page 224
clearances on record, most recent first.
Clearances — page 224
22,301–22,400 of 175,699- 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; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle
- 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
- K191388 — FloPatch (FP110)
- K191400 — Voyager Trajectory Array Guide (V-TAG)
- K182285 — PK High Tibial Osteotomy Correction System
- K182742 — DB-CMF
- K183354 — Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate
- K183450 — EmBody System
- K183580 — Panthera Dental Milled Bars
- K183624 — Kubtec Mozart (Xpert42)
- K190095 — Powder-Free Clear Vinyl Patient Examination Gloves
- K190122 — Renovis A200 PS Knee System as part of the Renovis A200 Knee System
- K190336 — Soniquence Bipolar Electrodes
- K190545 — VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0
- K191172 — Cepheid Xpert MRSA NxG Control Panel
- K191442 — Campylobacter Chek
- K191456 — Campylobacter Quik Chek
- K182638 — Hailie Sensor
- K182658 — Bioliner
- K182703 — EntericBio Dx Assay
- K182719 — Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro
- K182774 — STOP U (Packed Black USA), STOP U (Packed White USA)
- K182785 — LOQTEQ VA Foot Plates 2.5
- K190115 — MHD TENS
- K190387 — RayStation
- K190762 — The JASPER Spinal Fixation System II
- K190889 — Republic Spine Restore Cervical Interbody Fusion System
- K191418 — Multix Fusion Max
- K182493 — Bovine Pericardial Tissue Patch
- K182667 — Med-link Temperature Probes
- K183385 — NanoKnife System
- K183578 — Torpedo Gelatin Foam
- K190913 — QLAB Advanced Quantification Software 13
- K191049 — Stryker MIS and Footed Attachments
- K191209 — Aneroid Type Blood Pressure Kit
- K182524 — GALILEO Spine Alignment Monitoring System
- K182695 — Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter
- K190121 — IDS SHBG
- K190662 — MRI Compatibility for Existing Straumann Dental Implant Systems
- K190663 — Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6
- K190684 — LxHA PEEK Lateral IBF System
- K190936 — Q-Switched Nd: YAG Laser System
- K191368 — FlowTriever Retrieval/Aspiration System
- K190010 — Penumbra System Reperfusion Catheter JET 7
- K183195 — VIVO
Data sourced from openFDA. This site is unofficial and independent of the FDA.