FDA 510(k) clearances — page 34
clearances on record, most recent first.
Clearances — page 34
3,301–3,400 of 175,620- K243296 — Disposable Biopsy Needle
- K243655 — TurbAlign
- K250034 — Natural rubber latex male condom
- K250156 — Choice 2 DC
- K250266 — Ceragem Automatic Thermal Massager (CGM MB-2401)
- K250671 — FreeStyle Comfort (AS200 / FreeStyle Comfort)
- K250761 — KALA Therapy Wand (Model: KALA-03)
- K250762 — ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)
- K250772 — Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter
- K250820 — Disposable Trocars
- K250942 — Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK)
- K251134 — RipCord
- K251149 — AviClear Laser System
- K251155 — BD Cathena Safety IV Catheter
- K251352 — Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)
- K251436 — Resolve Anterior Cervical Plate System
- K251470 — ResiCem EX
- K251472 — Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System
- K251482 — AEON Endoscopic Powered Stapler
- K251786 — Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®
- K251808 — Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR Systems
- K243252 — ZBPro Diagnostic
- K244004 — Microcurrent Facial Device (CEC101, EE0101, EEI101)
- K250032 — Marquee Disposable Core Biopsy Instrument and Instrument Kit
- K250063 — ARENA Star, Galaxy Star
- K250072 — CONDUIT SYNFIX Evolution Secured Spacer System
- K250283 — RAP Femoral Venous Cannulae
- K251145 — Arthrex PushLock Suture Anchors
- K251169 — Vivid Pioneer
- K251830 — Sonosite LX Ultrasound System
- K251885 — CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant
- K251945 — TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)
- K242562 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
- K243500 — ARCHITECT iGentamicin
- K243731 — HEXIM Implant; Samwon General Abutments
- K250108 — OptiVu Shoulder
- K250133 — HARBOR Occlusion Device
- K250193 — Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue)
- K250247 — panaSIa SI Fusion System
- K250505 — EZ-FIDUCIALS
- K251520 — Cios Alpha; Cios Flow
- K251759 — Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers
- K240908 — Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)
- K241525 — ExcelsiusXR
- K250065 — DENSITY; DENZA; DENSITY Noir
- K250342 — Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl
- K250695 — Single-use Ureteral Access Sheath
- K251447 — K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)
- K251741 — PathLoc Lumbar Interbody Fusion Cage System
- K251761 — Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode
- K251766 — TumorSight Viz
- K251776 — EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert)
- K251804 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
- K243884 — TAVIPILOT
- K250496 — Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)
- K250827 — aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams
- K251502 — TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System
- K251863 — CustomSurg OrthoPlanner
- K243123 — IPL Treatment Device (MDSQMC-01)
- K243207 — BD Vacutainer® Eclipse Blood Collection Needle
- K243220 — Onera STS 2 (ONERA STS 2)
- K243255 — URIS Long Implant & Abutments
- K243280 — Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)
- K243678 — TalisMann Neuromodulation System
- K243679 — MammoScreen® (4)
- K243826 — SMR Reverse HP Shoulder System
- K250105 — Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)
- K250165 — Pastelle
- K250286 — Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)
- K250398 — Innovita Flu A/B Antigen Rapid Test
- K250448 — Disposable Percutaneous Nephrostomy Dilatation Kit
- K250733 — 3DOSE 1ml Syringe
- K250822 — SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse
- K250838 — Denudation Pipettes
- K251054 — Hem-o-lok PurplePlus Large Polymer Ligating Clips
- K251080 — IdentiTi II Cervical Interbody System
- K251291 — Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers
- K251390 — MTA vpt
- K251528 — syngo.via MI Workflows; Scenium; syngo MBF
- K251599 — Single-use Ureteral Access Sheath
- K251671 — Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems
- K243399 — Boehringer Laboratories Liver Retractor
- K243468 — Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)
- K243701 — AuroLase® System
- K243868 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses
- K250279 — RC-SwiftPrep
- K250312 — Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small
- K250391 — Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife® (Perfexion)
- K250415 — G0 Blood Pressure Monitoring System (G0)
- K250524 — Mendaera Guidance System
- K250587 — Orthoscan TAU Mini C-Arm
- K250684 — OPUSWAVE Dual Sensor Imaging System
- K250729 — Power Wheelchair (MOB1107)
- K250779 — CS-Pro MED
- K250848 — Identity Shoulder System
- K251031 — Fiber Laser Treatment Systems (HS-232,HS-233)
- K251049 — SurgiLight 1470 Diode Laser System (Model:Halo)
- K251241 — EMPOWR Revision Knee (EMPOWR Revision Knee Symmetric TT Cones)
- K251285 — Electric Wheelchair (HG-630)
- K251490 — 8 mm Assist Cannula; 12 mm Assist Cannula
Data sourced from openFDA. This site is unofficial and independent of the FDA.