FDA 510(k) clearances — page 281
clearances on record, most recent first.
Clearances — page 281
28,001–28,100 of 176,542- K172849 — Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray
- K172856 — Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider
- K173051 — Orthofix MJ-FLEX THE NEW METAIZEAU NAIL
- K173136 — Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses
- K173187 — MobileDiagnost M50
- K173284 — OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU)
- K173314 — LessRay System
- K173319 — KaVo NOMAD Pro 2 Handheld X-ray System
- K173331 — JOURNEY II XR Knee Instruments
- DEN170018 — NSS-2 System
- DEN170058 — MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay
- K170206 — Arthrex FiberTape Cerclage
- K170362 — VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS
- K171736 — Geri Embryo Incubator and Geri Dish
- K171815 — Registrado Scan
- K171873 — Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs
- K171886 — OverStitch SX Endoscopic Suturing System (ESS)
- K171901 — uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)
- K172851 — Microcyn Plus Antimicrobial Wound Care Solution
- K173003 — U50 Diagnostic Ultrasound System
- K173016 — Kindguard Powder Free Vinyl Patient Examination Gloves, Light Yellow Color
- K173289 — Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter
- K173329 — jFit Surgical Planner
- K170799 — AP 50/30 Insufflator with Insuflow Port
- K170859 — Dolphin/IQ and Dolphin/4D
- K171385 — Planmeca Romexis
- K171769 — Straumann PURE Ceramic Implants
- K172157 — DePuy Synthes Femoral Recon Nail System
- K172531 — Biograph mMR with mMR Angio Transfer Option
- K172759 — Smart External Drain (SED) System
- K173034 — FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)
- K173410 — n!ce for Planmill
- K163595 — IMPIX 3D Print Cages
- K170102 — Pekkton Ivory
- K170524 — Access AMH
- K170725 — Stryker Universal Mesh
- K170931 — CXI TriForce Peripheral Crossing Set
- K172344 — Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)
- K172525 — Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
- K172703 — Disposable Snap Electrode
- K173166 — ANTHEM Fracture System
- K171868 — A1AT Genotyping Test
- K171902 — Nexstim Navigated Brain Therapy (NBT) System 2
- K173271 — Aesculap Slim Clip Applier Forceps
- K161923 — J2A SLA Dental Implant System
- K162315 — FORTIFY Corpectomy Spacers
- K170071 — SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer
- K170534 — PROLIXUS TOTAL KNEE SYSTEM
- K170664 — Odyssey Micro Catheter
- K170900 — DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories
- K171050 — Geistlich Fibro-Gide
- K171392 — ulrichINJECT CT motion
- K171467 — BioZorb Marker GOLD / LP Marker GOLD
- K171850 — Philips CT Big Bore
- K171911 — Medline ReNewal Reprocessed Synthes External Fixation Systems
- K172006 — Alivio Ventricular Catheter and Flusher System (Alivio System)
- K172124 — Televere Podiatry Digital Imaging System
- K172226 — MX40 Release B.07
- K172453 — WATCHDOG Hemostasis Valve Kit
- K172458 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
- K172700 — OEC One
- K173273 — Aquarius 8600 1417WCI; Aquarius 8600 1717WCI
- K170229 — Dental High-speed Turbine Handpiece
- K170473 — C2 femoral stem
- K170773 — Stryker Universal Mesh
- K171131 — MHC Standard and NRFit Tip Syringes
- K171534 — SurgicalPreview
- K172083 — Idys ALIF System
- K172620 — SyndesMetrics Syndesmosis Repair System
- K172738 — RadiForce RX560, RX560-AR
- K172790 — ER-REBOA Catheter
- K173192 — CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit
- K173247 — Surgical Planning Software version 1.1
- K163694 — Rooti Rx ECG Event Recorder, Rooti Link APP Software
- K170464 — StatStrip Xpress Blood Glucose Monitoring System
- K170595 — IV Administration Sets
- K171004 — Hintermann Series H2 Total Ankle System
- K171365 — Arthrex Knee Systems
- K171473 — Compressyn Staple
- K172177 — Insulia Diabetes Management Companion
- K172392 — Lateral Spinal Truss System (LSTS) Interbody Fusion Device
- K172446 — SPIRA-C Open Matrix Cervical Interbody
- K173009 — NCompass Nitinol Stone Extractors
- K173086 — NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
- K173265 — UltraVision 2 Diagnostic Ultrasound System
- K163634 — External Hex Implants
- K172260 — Omni Foot Plating System
- K172441 — EPIC Extremity Fracture Plate System
- K172442 — Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
- K172604 — XW-100 Automated Hematology Analyzer for CLIA Waived Use
- K172712 — gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler
- K172979 — NuVasive® Growth Rod Conversion Set
- K170897 — Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site
- K170965 — Fingertip Pulse Oximeter
- K171788 — Reprocessed Halo XP Diagnostic Electrophysiology Catheter
- K171842 — Geistlich Wound Matrix
- K172045 — Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2
- K172054 — Materialise Glenoid Positioning System
- K172060 — Capio SLIM Suture Capturing Device
- K172277 — Phlebo Press DVT Model
Data sourced from openFDA. This site is unofficial and independent of the FDA.