FDA 510(k) clearances — page 201
clearances on record, most recent first.
Clearances — page 201
20,001–20,100 of 176,479- K201042 — PROBEAT-CR
- K201276 — ExacTrac Dynamic
- K201338 — Allograft MIS Delivery System
- K193627 — Automatic Upper Arm Blood Pressure Monitor
- K193628 — AGE Automatic Wrist Blood Pressure Monitor
- K192969 — Ezra Plexo Software
- K192994 — Paragon 28 APEX 3D Total Ankle Replacement System
- K193294 — AI-Rad Companion Engine
- K193559 — NextAR TKA Platform
- K193624 — Automatic Upper Arm Blood Pressure Monitor
- K200047 — ExcelsiusGPS Cranial 1.0 Module
- K200203 — Infrascanner
- K200409 — Pelvital System
- K200427 — Sonicision Cordless Ultrasonic Dissector
- K200449 — X-Cube 90
- K200450 — X-Cube 70
- K200480 — DreamStation 2 System, DreamStation 2 Advanced System
- K200568 — B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System
- K200856 — SmartLinx Vitals Plus Patient Monitoring System
- K201243 — Disposable Specimen Retrieval Bag
- K201279 — ASSISTO Universal Applicator Clamping Device
- K201299 — HD Steth
- K201343 — Triathlon Total KneeSystem
- K201389 — Resoundant Acoustic Driver System
- K201607 — Eclipse Treatment Planning System v16.1
- K201725 — DigitalDiagnost C50
- K192928 — Optiflux Enexa F500 Dialyzer
- K193113 — GC Temp Print
- K193272 — GTK Trocars
- K200061 — HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS)
- K200637 — SR-8100 Portable X-ray Unit
- K200823 — Zimmer, Inc. Hip Joint Prostheses MR Labeling I
- K200941 — Rapid LVO
- K201035 — ETHICON Linx Esophagus Sizing Tool
- K201296 — i-Rapha Solution
- K201586 — XACT Robotic System
- K201640 — DuraDiagnost
- K192231 — Dental Glass Ceramics Blocks
- K193345 — Arthrex DynaNite Compression Plate
- K200154 — B&J DVT Compression Devices MHH800/MHH800SQ
- K200599 — Digital Thermometer
- K200656 — Delta Multihole TT Pro Acetabular System
- K200676 — ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA
- K200955 — Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch
- K201216 — CAPERE Thrombectomy System
- K201307 — VisCalor
- K201542 — Arthrex Eclipse Shoulder Prosthesis System
- K201556 — Intraosseous Fixation System
- K201571 — ACTIV.A.C. Negative Pressure Wound Therapy System
- K201575 — CMDR 2C (Multiple Models)
- K201593 — Looking Glass 4K Integrated Visualization System
- K200392 — REXSIN
- K191152 — MIS Ti-base Abutment
- K193073 — Deep Recon
- K200330 — RC-Prime Root Canal Preparation Cream
- K200652 — Lollipop BiteBlock
- K200850 — Fujifilm Ultrasonic Processor
- K201235 — Arthrex MaxForce MTP Compression Plates and Screws
- K201540 — uMR570
- K200537 — Oxxiom
- K200795 — LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit
- K183471 — IC-WHCD100 (Inspire)
- K192385 — ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable
- K192411 — Psoria-Shield AURORA
- K192872 — ulrichINJECT CT Motion
- K192880 — InferRead Lung CT.AI
- K193172 — Luna XD Ti Interbody Fusion System
- K193252 — Contour ProtegeAI
- K193259 — Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer
- K193484 — GC Fuji Triage EP
- K200285 — VenaOne
- K200674 — AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector
- K200766 — 3M Attest Steam Chemical Integrator Test Pack
- K200894 — Agape Cooling Personal Lubricant
- K200947 — InMode System with the Morhpeus8 Applicators
- K201048 — SherpaPak Pediatric Liver Transport System
- K201487 — Traxcess 7 Mini Guidewire
- K201599 — 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+
- K201633 — Terason uSmart 3200T Plus Ultrasound System
- K200138 — Versana Premier
- K200248 — Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators
- K200561 — StimPlus Patch, StimPlus Patch, StimPlus Patch
- K200880 — T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System
- K201449 — SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring
- K201477 — syngo.via View&GO
- K191276 — Dental Electrical Motor iRoot Pro
- K192778 — Kinos Axiom Total Ankle System
- K193632 — LassoStar Circular Mapping Catheter
- K200265 — Surgical Drills
- K200272 — Terragene Chemdye
- K200874 — TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End
- K201455 — Litho 150, Cyber Ho 150
- K201464 — Altapore MIS
- K192900 — H500 Multi-Sensing Oximetry System
- K193119 — Twin-Pass Dual Access Catheter
- K200068 — Arthrex DynaNite K-Wire
- K200354 — Electronic stimulator
- K200420 — Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green
- K200698 — Somnera System
- K201156 — ARTIS pheno (VE2)
Data sourced from openFDA. This site is unofficial and independent of the FDA.