FDA 510(k) clearances — page 272
clearances on record, most recent first.
Clearances — page 272
27,101–27,200 of 175,699- K171136 — LIA Pregnancy Test
- K171492 — B7 2C Occlusion Balloon
- K172032 — Modulift Vertebral Body Replacement (VBR) System
- K172241 — Tyece OTC EMS System, Model EM35
- K172557 — Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach
- K172580 — ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length
- K172584 — Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach
- K172650 — Materialise PKA Guide System
- K172921 — Stryker Self-Punching ICONIX
- K172984 — Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive Surface
- K173018 — MDR17 Mobile Direct Radiographic System
- K173044 — Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
- K173169 — Rapid Family
- K173378 — syngo®.via protoNeo (Version VA20)
- K170544 — Langston dual lumen catheter
- K170856 — CMS600P2 B-Ultrasound Diagnostic System
- K171121 — Masimo Root Monitoring System and Accessories
- K171158 — Single Use Electrosurgical knife
- K171270 — DIGITAL RADIOGRAPHY CXDI-410C WIRELESS
- K171589 — AEON Endoscopic Stapler
- K171742 — N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2
- K171743 — Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination Gloves
- K171961 — Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)
- K172223 — SleepRight ProRx Custom Dental Guard
- K172318 — Endoform Silver Dermal Template
- K172362 — DEKA SMARTXIDE TOUCH
- K172363 — DEKA SMARTXIDE ULTRASPEED
- K172451 — Dr.MUSIC 3s
- K172472 — Micro-MEC 1.8% Glutaraldehyde Monitor Strip
- K172514 — Trak Plus Male Fertility Testing System
- K172660 — Duravess bovine pericardial vascular patch
- K172761 — New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)
- K172850 — SterilContainer with PrimeLine Pro Lid
- K172878 — Vantage Titan 3T, MRT-3010/A7, M-Power GX
- K173023 — Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold
- K173068 — Performer Introducer
- K173305 — NeuroBlate System
- K173355 — Gastric Sizing Balloon Catheter
- K173365 — Bausch + Lomb Boston Scleral Lens Case
- K173423 — MR Wire Guide Wire Straight, MR Wire Guide Wire Angled
- K173446 — Contour 24
- K163472 — Intra.Ox Handheld Tissue Oximeter
- K163643 — SIRIO H3
- K170022 — Klockner Vega TiBase for CEREC
- K170517 — Merits Model R106/R136 Rehab Wheelchair
- K170606 — Acrylic Herbst Appliance with Micro-Recorder
- K171254 — LeEject 2 Dental Syringe and Needle System
- K171482 — NEPHROCHECK Test System
- K171543 — Renovis Surgical Hip Replacement System
- K171610 — MC3 QuickFlow Dual Lumen Catheter
- K171618 — Symetrex Long Term Hemodialysis Catheter
- K171816 — Kardia Band System
- K172130 — Resorbable Mesh Device
- K172178 — Minimally Invasive Bunion Plating System
- K172535 — Bipolar applicator CELON ProCurve V
- K172550 — OEC Elite
- K172634 — Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.