FDA 510(k) clearances — page 35
clearances on record, most recent first.
Clearances — page 35
3,401–3,500 of 176,479- 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) +3 more
- 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 +2 more
- K250688 — Cedar Endovenous Radiofrequency Catheter (ERA-C70-US) +2 more
- K250894 — Eminent Spine Posterior SI System
- K252150 — Ultrasonic Bipolar Generator (USG-410) +5 more
- 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) +1 more
- K243152 — GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device
- K250523 — Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1) +4 more
- K250551 — 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)
- K250766 — LungQ 4
- K250860 — BreatheBand® (Model 1000)
- K251124 — G-Bond Universal
- K251215 — Philips IntelliSpace Cardiovascular
- K251398 — IPL Hair Removal Device (IPL-001, IPL-002)
- K251442 — TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)
- K252059 — CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)
- K252114 — MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL
- K252440 — EasyTeleMed (2.0.2)
- K252758 — Cannulated Screw and Kirschner (K wire) System
- K252769 — Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116)
- K250026 — Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000)
- K250083 — PRO-DOSE System
- K250767 — Newclip Patient-matched instrumentation non sterile PSI
- K251501 — Visby Medical Men's Sexual Health Test
- K251767 — Vena MicroAngioscope System
- K251825 — Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)
- K251899 — E Blator
- K252096 — Light Therapy Decollete Mask (1019135)
- K252447 — Picosecond laser device (BMPS4)
- K252804 — Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI20S WH, UI20WG +4 more
- K243270 — TigerConnect Alarm Management
- K250050 — miDiagnostics HSV-1&2 CSF Test
- K250331 — Astrasono A3Pro Bladder Scanner (A3Pro)
- K251197 — Dexter L6 System
- K251669 — IBP transducer adapter cable, Argon/BD/Ohmeda, 2m +8 more
- K251690 — Arthrex SpeedFLEX Implant
- K251799 — Mobility Scooter (6 models)
- K252072 — Francisella tularensis Real-time PCR assay
- K252085 — Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)
- K252106 — External Fixation Mini Rail System
- K252722 — Biopsy Forceps
- K243833 — Portable oxygen concentrator (JAY-1000P)
- K243983 — Paltop Dental Implant System
- K250023 — SMART PCFD
- K250123 — Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)
- K251104 — SureTome SW Sphincterotome with DomeTip
- K251334 — NEW DOUBLO 2.0
- K252051 — allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627)
- K252054 — SpineAR SNAP (SyncAR Spine)
- K252441 — Primero Safe Access System
- K252594 — UltraGuideCTR® image guided soft tissue release system
- K252770 — iLet ACE Pump
- K253236 — G-BLOCK
Data sourced from openFDA. This site is unofficial and independent of the FDA.