FDA 510(k) clearances — page 48
clearances on record, most recent first.
Clearances — page 48
4,701–4,800 of 176,479- K250243 — ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U) +3 more
- K250370 — SCENARIA View Phase 5.0
- K250489 — FP3D
- K250534 — Biomic Color Opaque
- K250602 — X-PAC® N-GAGE Lumbar Plate System
- K250866 — Sovereign Posterior Cervical System
- K251231 — ViewFlex X ICE Catheter, Sensor Enabled
- K242547 — AirFit F20 Mask System; AirFit F20 NM Mask System
- K242755 — Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)
- K243301 — MapRT
- K243411 — Diagnostic X-ray System
- K243601 — Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set
- K243643 — restor3d Reverse Total Shoulder Arthroplasty System
- K250020 — Diagnostic Ultrasound System (11+ models)
- K250038 — Muscle Stimulator Device (PZ-100)
- K250122 — SleepRight Snore Aid
- K250390 — CloSYS® Dry Mouth Sensitive Mouth Rinse
- K250447 — BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)
- K250456 — Dentemp Pro-Comfort Dental Guard
- K240554 — InferRead Lung CT.AI
- K241581 — Hemodialysis Catheter
- K241671 — 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
- K242438 — Clearo
- K242569 — Mixed Reality Spine Navigation
- K242585 — Cystatin C
- K242706 — Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio
- K242731 — MasteRad MiniX Mobile Digital Imaging System (Mini-X)
- K243105 — Ruby Intravascular Catheter
- K243176 — BLESSING System
- K243371 — Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1
- K243602 — Arthrex Spine Endoscope
- K243617 — uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis
- K243837 — iBSM
- K243927 — MobileLink Acetabular Cup System - inhouse coatings
- K244008 — Spectral CT
- K244033 — Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)
- K250086 — OTS Hip
- K250099 — Mobius3D (4.1)
- K250110 — Diagnostic Ultrasound System (12 models)
- K250141 — Synthecure Synthetic Calcium Sulfate
- K250971 — Embosphere Microspheres
- K251184 — AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System
- K240857 — Youmagic FLM System (YM5-U1)
- K242155 — DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)
- K242176 — BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)
- K242479 — BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU
- K242518 — Hypertension Prediction Index (HePI) Algorithm
- K242519 — Lumify Diagnostic Ultrasound System
- K242931 — HFT750U
- K243165 — Limfa Therapy System (Limfa Therapy)
- K250213 — OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit) +1 more
- K250276 — Nitinol Enhanced Device (NED)
- K250432 — Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500)
- K250444 — NEXUS® Hip Stem
- K250451 — NeurAxis IB-Stim (01-1020)
- K250454 — HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)
- K251156 — NPseal
- K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
- K242072 — CeraRoot TL Implant System (TL)
- 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) +6 more
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.