FDA 510(k) clearances — page 49
clearances on record, most recent first.
Clearances — page 49
4,801–4,900 of 176,479- K243290 — BTL-785MJ
- K243322 — Altaviz Intravitreal Syringe
- K243812 — Volta AF-Xplorer
- K250053 — TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)
- K250299 — CT/ MR Tandem and Ovoid Set
- K250400 — Vigeon Laparoscopic Universal Smoke Evacuator (VG003)
- K250758 — Electric Wheelchair (F309)
- K251103 — VeriSight Intracardiac Echocardiography Catheter (VSICE2D) +1 more
- K251110 — EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
- K251126 — SKOUT system
- K251425 — turbodent touch
- K233271 — OsseOne Dental Implant System
- K242410 — NextStep Arthropedix Total Knee System
- K242670 — Lumify Diagnostic Ultrasound System
- K243110 — eFOLDi Navigator Powerchair (STPC-A)
- K243226 — Ultrasound Imaging System (3 models)
- K243419 — Altus Spine Navigation System
- K243764 — Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)
- K243824 — Preat Abutments
- K250226 — Clarius Median Nerve AI
- K250482 — Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue
- K250582 — COLONNADE Posterior Screw Fixation System
- K251133 — AVEA disposable expiratory filter/water trap (11790)
- K242975 — Mobility Scooter (Model X-01, X-02)
- K243684 — BrightHeart View Classifier
- K243776 — Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)
- K250222 — SDF Pro
- K251111 — Cary
- K251128 — Extremity Medical External Fixation System
- K241980 — !M1
- K243017 — IPL Hair Removal Device (NV-TM10A, NV-TM10C, NV-TM10D)
- K250160 — ANKYRAS
- K250253 — IPL Hair Removal Device (KCA511/KCA516/KCA522)
- K250785 — Single-use Flexible Ureteroscope
- K251094 — Alma Veil
- K240447 — ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)
- K242386 — Bluemoon
- K242754 — ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)
- K242937 — Dream Medi Sterile Surgical Gown (SurgicalGownUL)
- K242962 — Telemetry Monitor 5500 Release 4.0 (867232)
- K243370 — DentaTOOTH
- K243603 — AeviceMD
- K243893 — Second Opinion® Pediatric
- K250728 — Arthrex Synergy Vision Endoscopic Imaging System
- K242583 — AT-Patch (ATP-C130/ATP-C70)
- K242763 — JetCan® Pro Safety Huber Needle
- K242986 — SpO2 Extension Cable
- K243043 — Origin Cemented Hip Stem
- K243069 — LUMYS (V1)
- K243114 — SQA-iOw Sperm Quality Analyzer
- K243457 — Nixall Antimicrobial Solutions Skin & Wound Hydrogel
- K243757 — Shockwave CS Guide Catheter
- K243828 — CIONIC NEURAL SLEEVE (NS-200)
- K243894 — F88 URE-SD/RD Flexible Ureteroscope
- K244001 — KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)
- K244014 — i-STAT CG4+ cartridge with the i-STAT 1 System
- K250161 — Wrist Blood Pressure Monitor (12+ models)
- K250292 — OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)
- K250629 — Sutil Rich Personal Lubricant
- K251048 — Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118
- K251056 — Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode
- K251071 — Fetal EchoScan (v1.1)
- K242315 — Resolve Modular Revision Hip Stem
- K243521 — Conical Ti Base abutments
- K243870 — X°Port Lung Preservation System; X°Port Lung Preservation Solution
- K244020 — Wrinkle Treatment Device (JM1, JM2B)
- K250029 — ONE TRAY® Sealed Sterilization Container System
- K250087 — Vscan Air
- K250296 — Disposable Distal Attachment D-201 Series
- K250641 — APEX 3D Total Ankle Replacement System
- K250995 — Xpert Xpress CoV-2/Flu/RSV plus
- K250996 — Xpert Xpress CoV-2/Flu/RSV plus
- K251007 — CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)
- K251014 — APRO 45 Catheter
- K243541 — LumiRex Bronchoscope
- K243934 — Stable-L Lumbar Interbody System
- K243942 — Arctic Sun Stat Temperature Management System
- K244000 — Arm Blood Pressure Monitor (4 models)
- K250274 — ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)
- K250282 — Persona C HR
- K250295 — Dentsply Sirona Titanium Bases system
- K250328 — UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program
- K250497 — Additive Manufacturing (Light Curing) Crown Bridge Resin
- K250683 — Resolve Fundus Camera
- K250907 — Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set
- K251015 — APRO 45 Catheter and Alembic Aspiration Tubing
- K251024 — TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
- K251051 — AuST Steerable Sheath
- K242211 — PUMA-G Pediatric System
- K242255 — Qitexio® 4-Way Stopcock (QIT014)
- K242354 — AllNEB
- K242495 — LMA Fastrach ETT SU
- K243886 — ExpressCore Biopsy Device
- K243963 — Pediatric Plating Platform Hip
- K250069 — Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
- K250308 — Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)
- K250617 — Apex Flex
- K250962 — APRO 55 Intermediate Catheter
- K241663 — Eminent Spine 3D Titanium Pedicle Screw System
- K242951 — Diode laser hair removal machine (QDTM-02)
Data sourced from openFDA. This site is unofficial and independent of the FDA.