FDA 510(k) clearances — page 40
clearances on record, most recent first.
Clearances — page 40
3,901–4,000 of 175,620- K242437 — Smile Dx®
- K242624 — Medical Image Post-processing Software (uOmnispace.CT)
- K243830 — Disposable ureteral stent
- K250041 — Medical Picosecond ND: YAG Laser System (PZ-6)
- K250405 — Nerivio; Nerivio Infinity
- K250414 — CaloPix
- K250420 — Helios Dura Regeneration Matrix
- K250533 — Magnesium alloy scooter (RS100)
- K250712 — Linkt Compression Staple System
- K250775 — Symphony Thrombectomy System; Symphony 16F 82cm Thrombectomy System
- K250813 — MICROLET®NEXT 2 Lancing Device
- K250835 — ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T)
- K251288 — Veincare
- K242674 — Freedom Posterior Cervical Screws
- K242762 — Aesculap Aicon® Series Container System
- K242808 — Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5
- K250418 — Ulthera System (UC-1 Control Unit PRIME Model 2.1)
- K250786 — SP Endoscope, 0° (430600)
- K251138 — Promisemed Safety Huber Needles
- K242418 — P-Cure Proton Therapy System (PPTS)
- K242477 — Shoulder Soft Tissue Anchors
- K243509 — Archer PSI System
- K243632 — uWS-Angio Basic
- K244050 — AYON Body Contouring System (AYON SYSTEM)
- K250393 — ZircaGlow & ZircaGlow HT Zirconia
- K250421 — InThrill Thrombectomy System
- K250431 — Medical Diode Laser Hair Removal System (MNLT-D1)
- K250592 — NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)
- K250763 — Reon
- K250868 — SPECTRALIS HRA+OCT and variants
- K250360 — TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026)
- K250377 — Flowflex Plus COVID-19 + Flu A/B Home Test
- DEN240045 — Teal Wand
- K241086 — Avidhrt Sense SpO2
- K242294 — DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls
- K242388 — LensHooke X12 PRO Semen Analysis System
- K242392 — PATH BGC
- K242692 — SteadiSet Infusion Set
- K242732 — Tristel OPH
- K243107 — Water Solubility Human Body Lubricant
- K243230 — Second Opinion® BLE
- 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); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D)
- 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 (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series)
- 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 (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo
- K250292 — OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)
- K250629 — Sutil Rich Personal Lubricant
Data sourced from openFDA. This site is unofficial and independent of the FDA.