FDA 510(k) clearances — page 35
clearances on record, most recent first.
Clearances — page 35
3,401–3,500 of 175,620- K251720 — OsteoFlo HydroFiber
- K251746 — Pure Impact
- K243485 — Alinity m CMV
- K243690 — SonoMSK
- K243779 — Bunkerhill Abdominal Aortic Quantification (AAQ)
- K250016 — droplet® personal lancets
- K250096 — Felix NeuroAI System
- K250204 — Endoscopic Camera System
- K250221 — StrokeSENS ASPECTS Software Application
- K250699 — Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K)
- K251032 — MiniMed 780G insulin pump
- K251212 — Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)
- K251453 — Arthrex iBalance Partial Knee System
- K251719 — Momentum® Posterior Spinal Fixation System
- K251933 — SnugFit ASA Extension
- K243647 — Synapse PACS (7.5)
- K250022 — HeroTracker Sense
- K250484 — PIUR tUS inside
- K250670 — EchoConfidence (USA)
- K250987 — aprevo® posterior/transforaminal lumbar interbody fusion device
- K250990 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL
- K251000 — Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)
- K251088 — Otsuka Digital Feedback Device
- K250972 — Primum Hydrophilic Guiding Catheter
- K242988 — Genostis Osteosynthesis System
- K243077 — Affirm 800
- K243130 — Integral Dental Unit
- K243144 — X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
- K243183 — RTMsense Respiratory Monitoring System
- K243187 — Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)
- K243190 — USTOMED Bone Fixation/Bone Augmentation Systems - PIN
- K243388 — Disposable Distal Cap
- K243682 — SonoPlex STIM; SonoPlex II
- K243816 — Testa TP Pivoting Spacer System
- K243900 — eMotus Respiratory Motion Management System
- K250310 — VIKING Fixed Curve Diagnostic Catheter
- K250522 — Multi4 System
- K250585 — LumenaTM Ureteral Access Sheath
- K250610 — Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)
- K250648 — Philips iCT CT system
- K250828 — CPS Locator 3D Plus Delivery Catheter
- K250969 — JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST
- K250984 — Maestro System (REF100)
- K251116 — Luja Coudé
- K251210 — Ampa One System (AMPA-001)
- K251329 — Diode laser device (RF3120-BI)
- K251431 — FIX-C PEEK ACIF SA System
- K251642 — Dental CBCT X-ray System
- K251654 — BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter and BD Insyte Autoguard BC Pro Shielded IV Catheter
- K251660 — T3 Pro Implants ZimVie Packaging System
- K242846 — Doppler FHR Detector (BF-500D+, BF-560)
- K243079 — NeuroTrac® MyoPlus Pro (MYO120U)
- K243175 — Disposable Intermittent Catheter (TPU Catheter)
- K243179 — Sterilization Pouch and Roll
- K243275 — Equinoxe® Scapula Fracture System
- K243391 — AISight Dx
- K243636 — Neuralytix iD3 System (NTX-9001)
- K250519 — Lap.Ox Laparoscopic Tissue Oximeter
- K250548 — Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)
- K250929 — TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm)
- K250940 — Atmo Gas Capsule System
- K250956 — HardyDisk AST Gepotidacin 10µg (GEP10)
- K250967 — Sherlock
- K251395 — The Rialto SI Fusion System
- K251613 — SwissGraft X
- K251632 — Optimas MAX System
- K251694 — safety lancet
- K251717 — Freedom® Total Knee System Titanium Tibial Base Plate
- K251728 — Velacur One (LI-1100)
- K242845 — EGIS Biliary Double Bare Stent (BDB080405)
- K243112 — Curapuls 670
- K243184 — SAT CenterFlow Molding Balloon Catheter (IN20-00313)
- K250302 — Flexible Partial Resin
- K250329 — GeniPhys Collymer Self-Assembling Scaffold
- K250747 — Globe® Pulsed Field System
- K250774 — SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture
- K250921 — CORIOGRAPH Pre-Op Planning and Modeling Services
- K250943 — Sysmex XR-Series (XR-10) Automated Hematology Analyzer
- K250966 — CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H)
- K251003 — X-PAC® LLIF Expandable Lateral Cage System
- K251371 — Sysmex XR-Series (XR-20) Automated Hematology Analyzer
- K251606 — Power Wheelchair (D26)
- K251611 — Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)
- K251627 — BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)
- K251725 — ANAX OCT Spinal System
- K243009 — MIST IC
- K250268 — HyperSnap Surgical System (HSS)
- K250326 — Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)
- K251358 — Bridge Plus Occlusion Balloon (590-002)
- K251362 — PediFlex Flexible Nail System
- K251644 — ProAM ALIF System
- K251648 — GPS Advanced; GPS Advanced Cannula
- K242924 — OPXION Optical Skin Viewer (OPXSV1-01F)
- K243142 — Cranial 4Pi Immobilization
- K243339 — WiTOF
- K250143 — Digital Prism Correction Feature (DPCF)
- K250470 — Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)
- K250862 — EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100)
- K250885 — Ceftobiprole BPR 5 µg Disc
- K251271 — TempFIT Temporary Crown and Bridge Resin
Data sourced from openFDA. This site is unofficial and independent of the FDA.