FDA 510(k) clearances — page 16
clearances on record, most recent first.
Clearances — page 16
1,501–1,600 of 176,428- K254183 — MR Conditional Cup Electrodes
- K254276 — Lynx Aspiration Catheter System
- K260460 — Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue
- K260974 — CO2 Laser Machine (Monica-I,Monica-II)
- K252552 — Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)
- K253027 — Anchor with Fiber Wire and Disposable Inserter
- K253152 — BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)
- K253855 — KardiaPSI Balloon Catheter
- K260376 — Denture Base
- K260747 — YP-710T Series NIBP Cuff; YP-840T Series Disposable Cuff
- K260775 — Polyethylene; Polyethylene Fusion; Polyethylene OrthoTape
- K261112 — CastleLoc-P Anterior Cervical Plate System
- K252558 — Lumify Diagnostic Ultrasound System
- K254200 — Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14)
- K254202 — MectaLIF 3D Metal Anterior
- K260742 — Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)
- K261130 — AccelFix Spinal Fixation System
- K261132 — Healium Intelliscan LX192LC
- K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)
- K252622 — Male Latex Condom HA
- K252954 — MammoSightAI
- K253251 — Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b)
- K254019 — Wound Geni NPWT System
- K254115 — ArteraAI Breast
- K260256 — Q-Switched Nd: YAG Laser Systems
- K260688 — Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)
- K260716 — Neowise
- DEN240075 — Prolystica Pass Thru Disinfectant Wipes
- K252073 — VOCO Profluorid Varnish + BioMin
- K252439 — Tutamen Self Adhesive Electrodes
- K252475 — ABL90 FLEX PLUS System
- K252488 — ABL90 FLEX PLUS System
- K252635 — ArthroTAK Tendon Anchor Kit
- K253030 — Capnostream35 Portable Respiratory Monitor (PM35MN)
- K253326 — Oxiplex
- K253663 — Zeta Navigation System
- K253887 — Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)
- K253966 — PERLA® TL Posterior Thoraco-lumbar Fixation System
- K254077 — OSSIOfiber® Threaded Trimmable Fixation Nail
- K254139 — BioCode® Respiratory Pathogen Panel (RPP)
- K254154 — FX V135 EASYTECH® Shoulder System
- K254234 — Phototherapy System (DUV-COMBO)
- K260314 — Ancora-SB
- K260819 — Any-Com Seal
- K260910 — EndoTool IV Cloud 1.0
- K261045 — Verifine Safety Lancets
- K261074 — BIOMONITOR IV (471155)
- DEN250023 — Aurie System
- K250680 — Bayesian Health Sepsis Flagging Device
- K251583 — Ambu® Virobac II® Exhalation Filter
- K252455 — FSYX Ocular Pressure Adjusting Pump
- K252503 — Intelligent NR
- K252849 — AffloVest® Mobile Airway Clearance Therapy
- K252858 — 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)
- K253017 — BloodSTOP iX Trauma Matrix (TM-iX-20)
- K253064 — Air Pressure Therapy System (3 models)
- K253436 — c-med0 alpha
- K253976 — iLet ACE Pump
- K254189 — Synapse 3D Base Tools (V7.2)
- K260323 — OrthoPediatrics® Locking Cannulated Blade Plate System
- K260342 — AllTest Strep A Rapid Test
- K261067 — BEE PLIF Cage
- K261404 — UltraEZ
- K252471 — Paptizer 360
- K252542 — LEO Spinal System
- K253166 — F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)
- K253401 — SCRIPT Implant System
- K253579 — Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire
- K253682 — DeepHealth ProstateAI
- K253885 — PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS +1 more
- K253914 — Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)
- K254184 — syngo Application Software
- K260589 — ES-Series
- K260606 — Echo Large Bore Introducer Sheath
- K261086 — Break Wave
- K261094 — YellowStar
- K252424 — Anti-HCV Next
- K252464 — Surgical Microscope (OMS2360, OMS2380)
- K252501 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L)
- K252831 — Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)
- K253243 — Cardinal Health Poly Reinforced Surgical Gown
- K253940 — M.U.S.T. Pedicle Screw System - Extension
- K260065 — SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx
- K260076 — SAM 3.0 Multi-Hour Continuous Ultrasound Device
- K260121 — Manual Wheelchair (7101L, 7102LHD)
- K260194 — Vacuum Pump (Model: AD-VPUM-500)
- K260248 — Ultra-Fast Warm
- K260260 — Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)
- K252409 — TearCare MGX System
- K252445 — Fusion Bioline Vascular Graft
- K252628 — CASSIE
- K252748 — Pelvic Floor Exerciser (PF01)
- K253658 — STA Satellite Max®
- K260182 — Avenir® Müller Stem; Avenir Complete Hip System
- K260660 — SABER-C System
- K261032 — NovoKnee (SteriKnee)
- K261356 — Dura-Crown
- K261357 — Grandio disc multicolor
- K253580 — Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)
- K250234 — SMARTeZ Elastomeric Infusion Pump (RS series)
Data sourced from openFDA. This site is unofficial and independent of the FDA.