FDA 510(k) clearances — page 26
clearances on record, most recent first.
Clearances — page 26
2,501–2,600 of 175,620- K252946 — BioBrace® Extra-Articular Ligament Augmentation Kit
- K253348 — TargetCool-e
- K250115 — Hemastyl() Wound Dressing
- K250776 — Lithoblast Single Use Holmium Laser Fibers
- K251715 — FlowArt® Vial Access Device Vented
- K251874 — PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)
- K252234 — IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16, FDA17, FDA18, FDA19, FDA20, FDA21S, FDA22S, FDA23S, FDA24S, FDA25, FDA26, FDA27, FDA28, FDA29S, FDA30S, FDA31S)
- K252637 — Community Containers (Flap and Daisy)
- K253010 — Mini Superhawk Suture Anchor System
- K253099 — LIFEPAK 15 AC Power Adapter (41577-000333)
- K253331 — PressON Spinal Fixation System
- K253461 — Demi Pro
- K251522 — Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE
- K242227 — GENEO X ELITE
- K251034 — Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44)
- K251595 — COVID-19 Detect Rapid Self -Test
- K243078 — HexaPLUS S OneDrill Implant System
- K243815 — SoClean 3+
- K250085 — On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System
- K250249 — Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
- K250351 — Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)
- K251082 — HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)
- K251602 — Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging
- K251708 — EvoEndo Single-Use Endoscopy System
- K251835 — Yomi Robotic System
- K251866 — Tegaderm Post-Op Transparent Antimicrobial Dressing
- K251927 — Zeta Navigation System (ZNS131-US)
- K252001 — Collagen Wound Dressing
- K252209 — IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032)
- K252312 — Eleganz IM Threaded Nail System (IM Threaded Nail System)
- K252544 — TMINI Miniature Robotic System
- K252737 — DeGen Medical Latitude-C AM Cervical Interbody Fusion System
- K252903 — Verruca-Freeze H Plus
- K250645 — SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)
- K251366 — EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)
- K251651 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
- K251795 — Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)
- K251851 — DIASAFEplusUS (F00013010)
- K251876 — cleadew GP hydra one
- K252272 — ORA Method LED Gua Sha (GS-04)
- K252553 — Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)
- K252600 — Pediatric Plating Platform I Small-Mini
- K252867 — VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup
- K252870 — Invisalign Specifix Attachment System
- K252910 — Orca Air/Water and Suction Valves
- K252911 — Lux HD 2530 detector (Lux HD 2530)
- K252939 — COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS
- K253094 — iFuse Bedrock Granite Implant System
- K250060 — GT300; GT300-C
- K250298 — Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)
- K250536 — MetaFore Small Screw System
- K251162 — CUSA® Clarity Ultrasonic Surgical Aspirator System
- K251363 — ProKnow DS
- K251422 — BD Saf-T-Intima Subcutaneous Catheter System
- K251699 — The Botticelli (Model: Athena)
- K252163 — Elecsys Phospho-Tau (181P) Plasma
- K252766 — 14Fr Low Profile Introducer Kit
- K252874 — Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01
- K244041 — Ultrasound Therapy Workstation (XMS-UET2)
- K250187 — Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)
- K250364 — Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
- K250688 — Cedar Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US)
- K250894 — Eminent Spine Posterior SI System
- K252150 — Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm (TB2-0545FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm (TB2-0535FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm (TB2-0525FC); THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm (TB2-0520FC)
- K252214 — AIAS Cephalon
- K252572 — Prodeon Urethral Sheath System
- K252851 — deepLive (OSP12 + DMS)
- K252948 — TrueBeam, TrueBeam STX, Edge and VitalBeam
- DEN240073 — PainChek (PainChek Adult)
- K250173 — Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley Oral RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (115-XXOR) Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (119-XXNR)
- K251565 — Wheelchair (N817)
- K251603 — Tigertriever 17 Ultra Revascularization Device
- K252007 — BlineSlide
- K252140 — Heylo System
- K252502 — Folding Mobility Scooter (KD101)
- DEN220077 — ProSense System
- K242946 — HESTIA (L200-A)
- K243968 — Revolve Surgical System
- K250028 — Anti Snore Mouthpiece
- K250031 — Amplatzer Guidewire
- K250039 — HPACS
- K250073 — Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01
- K250662 — Bunkerhill MAC
- K251426 — da Vinci SP Surgical System (SP1098)
- K251464 — TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)
- K251468 — Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A)
- K251639 — xvision Spine system
- K251646 — extriCARE® 1000 Negative Pressure Wound Therapy System
- K251859 — EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
- K252129 — AETOS Shoulder System Stemless Humeral Prosthesis
- K252178 — MAGENTIQ-COLO (ME-APDS)
- K252517 — Manual Wheelchair (SYIV100A008)
- K252806 — Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)
- K252820 — PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)
- K243152 — GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device
- K250523 — Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5)
- K250551 — 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)
- K250766 — LungQ 4
- K250860 — BreatheBand® (Model 1000)
- K251124 — G-Bond Universal
Data sourced from openFDA. This site is unofficial and independent of the FDA.