FDA 510(k) clearances — page 15
clearances on record, most recent first.
Clearances — page 15
1,401–1,500 of 175,620- K260217 — AI Platform 2.2 (AIP002)
- K260287 — SP Electrocautery Device (SP20)
- K260377 — XSense Cryoablation System with CryoProbes
- K251587 — VITA VMLC Primer
- K251661 — Mariana Minerva; Mariana Nimbus
- K251864 — Rubber Utility Catheter
- K252795 — ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial
- K253068 — Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe
- K253169 — Duet Spinal Fixation System
- K253228 — YUWELL® Electronic Blood Pressure Monitor (YE650AR)
- K253244 — AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)
- K253486 — SKIA-Head (Model: SKIA-ST00)
- K253531 — Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)
- K253583 — LUX Expandable Lumbar Interbody System
- K253631 — Mobility Scooter (CL-Q3, CL-Q4)
- K253648 — Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades
- K253666 — IPL Hair Removal Device (Models: T31A, T32A)
- K260043 — Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)
- K260265 — MAGNETOM Flow.Ace; MAGNETOM Flow.Plus
- K253646 — Single Use Distal Cover MAJ-2315 (MAJ-2315)
- K251692 — Advanced Tissue Resection Device
- K251653 — SPRY TMS Therapy System (0550)
- K251890 — Disposable Ureteral Stents
- K252500 — CARA System
- K252619 — QSCHECK UISACR
- K252672 — CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)
- K252972 — CARTO 3 EP Navigation System V8.4
- K252989 — POINT Kinguide Agile Hybrid Navigation System; DRF Accessories Set
- K253445 — BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120)
- K253605 — Safety Heel Lancet
- K253653 — Xpert Hemorrhagic Fever
- K253660 — KLS Martin Pure Pectus System
- K253683 — FAQ (LED Panel); FAQ (Dual LED Panel)
- K254162 — KLS Martin Ixos System
- K260181 — LF Process Indicator Tape for Steam Sterilization
- K251903 — Erchonia DPN Laser (Model# EVRL)
- K252002 — Monaco RTP System (6.3)
- K252597 — Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)
- K252733 — ATLAS Expandable Osteotomy Wedge System
- K252814 — Profoject Low Dead Space Syringe /Profoject Tuberculin Syringe; Profoject Low Dead Space Syringe with Needle /Profoject Tuberculin Syringe with Needle; Profoject Low Dead Space Syringe with Permanent Needle /Profoject Tuberculin Syringe with Permanent Needle; Profoject Low Dead Space Safety Syringe /Profoject Tuberculin Safety Syringe
- K253002 — SkinStylus SteriLock MicroSystem (MP1209SL)
- K253203 — Retrograde Coronary Sinus Perfusion Cannulae
- K253398 — Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)
- K253612 — Acclarent AERA Eustachian Tube Balloon Dilation System
- K253623 — Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor
- K253687 — Access anti-HBc Total
- K254018 — Portable Dental X-ray Device (GT-1)
- K254148 — VERTICALE GPS Instruments
- K254188 — Meniscus Versaflex
- K260163 — AuST CSP Introducer
- K260205 — AS Software Version Asera
- K260218 — LacertaMatrix
- K260308 — TrueFit Bolus
- K252098 — PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)
- K252197 — Nobel Biocare S Series Implants
- K252561 — BTL-754FF
- K253539 — Alere NT-proBNP for Alinity i
- K253637 — Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert
- K253643 — Mobility Scooter (S3)
- K260185 — 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality
- K250550 — FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit
- K251680 — Biosteon® Screw
- K252805 — YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
- K253524 — Adaptos®Fuse Bone Graft
- K253599 — Electric Wheelchair (W-A807, W-A807L)
- K254089 — IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035)
- K260149 — Versus Catheter (VS110-9NB)
- K243854 — Contour Light (CL-100)
- K250233 — PreemptiveAI Clinical SDK
- K251581 — Wearable Ambulatory Blood Pressure Monitor (WBP-02A)
- K251619 — Babyleo TN500
- K251742 — VELO Respiratory Test
- K251802 — STAR RF Ablation System
- K251852 — cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)
- K251928 — CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)
- K252400 — Endomina EZFuse system
- K252420 — Wearable Breast Pump (Model W12)
- K252422 — Wearable Breast Pump (Model W2)
- K252512 — Armada 14 NC PTA Catheter
- K252565 — PreOp v3
- K252685 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)
- K252891 — MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)
- K253089 — NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)
- K253092 — Argos Infinity (Rev. 1.0)
- K253096 — Chartis Precision Catheter
- K253133 — Wrist Blood Pressure Monitor (BPM-W1VL)
- K253149 — Motion InBra (YM-8801) wearable breast pump
- K253564 — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)
- K254052 — DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal
- K254105 — Hive Standalone Cervical System and Hive C Interbody System
- K260130 — Willow 18 Guidewire
- K251375 — PuraCath Firefly Needleless Connector IT (9005)
- K251732 — Wrist Fracture System
- K251760 — Well-Life Incontinence Stimulation System (WL-2405i(P))
- K252490 — Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)
- K252523 — Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test
- K253201 — Lumbar Spine Truss System - Plating Solution (LSTS-PS)
- K253354 — Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)
- K253381 — Stealth AXiS Surgical System with Stealth AXiS Spine clinical application
- K253490 — Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions
Data sourced from openFDA. This site is unofficial and independent of the FDA.