FDA 510(k) clearances — page 57
clearances on record, most recent first.
Clearances — page 57
5,601–5,700 of 175,620- K242399 — Bonebridge Osteosynthesis Plating System
- K242623 — Disposable Blood Pressure cuff; Reusable Blood Pressure cuff
- K243181 — Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo
- DEN230082 — Stone Clear (SC-LP9-01)
- K240177 — Zio AT® device (A100A1001)
- K240333 — Wearable Digital Thermometer (T31)
- K240334 — LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D)
- K240560 — ZENEX Implant System_Long
- K240670 — DRI Ecstasy Plus Assay
- K240847 — MedicCO2LON (MedicCO2LON)
- K241108 — RemedyLogic AI MRI Lumbar Spine Reader
- K241533 — NeurAxis IB-Stim (01-1020)
- K241902 — Edison System
- K242271 — Caduceus S
- K242627 — Safety Lancet
- K242711 — JOURNEY II Unicompartmental Knee System (JOURNEY II UK)
- K243186 — Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA30A Family
- K240175 — Tigon Medical Fractures, Instability, and Reconstruction (FIRE)
- K241077 — DeGen Medical Patient Specific Implant (PSI) System
- K241189 — Electric Wheelchair (ME23-EW16-BC200-01); Electric Wheelchair (ME23-EW16-BC200-02)
- K241366 — QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)
- K241612 — Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2)
- K241965 — Catheter Surface Flap Applicator Set (GM11011830)
- K242256 — QIAstat-Dx Meningitis/Encephalitis (ME) Panel
- K243080 — Riptide Aspiration System
- K243095 — Mammotome AutoCore Single Insertion Core Biopsy System
- K243126 — TRACHEOBRONXANE DUMON®
- K243157 — AtriCure cryoICE BOX (ACM)
- K243203 — OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor
- K243247 — Persona the Personalized Knee System
- K240303 — MetaLite DX Digital Pathology Software
- K241630 — ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T)
- K241718 — Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)
- K241992 — Catalyft LS Expandable Interbody System
- K242350 — Spinal Alignment Solutions Pelvic Incidence (PI) Rod System
- K242622 — Sterile Lancets for Single Use
- K243137 — Curiteva Porous PEEK Laminoplasty System
- DEN230084 — Dexter L6 System
- K240040 — VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)
- K240092 — Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504)
- K240223 — FMT Disposable and Autoclavable Temperature Probes
- K240269 — Nitrile Powder Free Examination Gloves Biodegradable (Green)
- K240918 — Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia; Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism
- K241185 — CORGRIP* SR NG/NI Tube Retention System
- K242215 — Neurophet AQUA (V3.1)
- K242353 — QIAstat-Dx Respiratory Panel Mini
- K242397 — LYNX Photocoagulator
- K242625 — Freeze Point & Private Label Versions
- K242956 — LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle
- K242969 — Pantera Pro; Pantera LEO
- K242984 — BKS Revision System
- K243030 — Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)
- K243031 — LCD Monitors C310S, G310S, C316S, G316S, C616W
- K243070 — Xpert® SA Nasal Complete
- K243173 — Salto Talaris Ankle PSI System
- K243174 — Cadence Ankle PSI System
- K243189 — TumorSight Viz
- K240391 — MUTARS® femoral stem cemented 160 mm and 200 mm
- K240543 — Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)
- K241007 — Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)
- K241089 — KeyPrint KeyDenture Base
- K241554 — Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)
- K242034 — Duet External Drainage and Monitoring System (EDMS)
- K242086 — MagDI System (MAG-01, DS-01)
- K242458 — ArgenZ MTZ
- K242462 — CEREC Cercon 4D CAD/CAM Blocks
- K242512 — ROCC Console
- K242560 — Manual Wheelchair (SYIV100-CA9221)
- K234060 — KIDNEYvault Portable Renal Perfusion System
- K240289 — Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)
- K240865 — IDS-iSYS Free Testosterone
- K241324 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
- K241753 — Immediate Molar Implants
- K241876 — Vitesse (5.0)
- K241988 — ProSeal Closed System Bag Access
- K242073 — STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)
- K242183 — Fractional CO2 Laser Therapy System (EXFU CO2)
- K242513 — FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)
- K242589 — Scarlet® AL-T
- K242829 — BluEX Lumbar Expandable Cage System
- K242847 — EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA);
- K242995 — OIC Small / Mini Fragment Plate System
- K243007 — CD Horizon Spinal System
- K243012 — MIM Symphony HDR Fusion
- K243057 — TrueFit Bolus; TrueFlex Bolus
- K240506 — KARL STORZ Holders
- K241398 — SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses
- K241478 — Tri-Wedge PTA Scoring Balloon Dilatation Catheter
- K241532 — Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)
- K241572 — ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)
- K241758 — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)
- K242099 — Sol-M Slip Tip Syringe without Needle, Sol-M Eccentric Tip Syringe without Needle
- K242193 — Arm Type Blood Pressure Monitor (BPM82)
- K242250 — PuraStat
- K243209 — nordicMEDiVA
- K222740 — Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch
- K240029 — Zio AT® device (A100A1001)
- K240783 — Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems
- K241170 — Dynamic TiBase; TRI Screws
- K242058 — Digital Prism Correction Feature (DPCF)
Data sourced from openFDA. This site is unofficial and independent of the FDA.