FDA 510(k) clearances — page 307
clearances on record, most recent first.
Clearances — page 307
30,601–30,700 of 176,542- K161273 — StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis
- K162226 — Reliant Multistage Dilatation Balloon Catheter
- K162786 — PASS LP Spinal System
- K162988 — PreludeSYNC Radial Compression Device
- K163258 — CrossFT Knotless Suture Anchor with Disposable Driver
- K161466 — ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
- K161686 — F&P InfoSmart
- K162802 — Barrx Anorectal RFA Wand
- K162851 — eLyx-PRO
- K162924 — Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White) +2 more
- K163006 — VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)
- K163014 — AOS Small Bone Nailing System
- K163705 — EzRay Air W
- K170074 — nvc
- K160591 — D.O.R.C. Disposable Cryo Probe
- K161231 — Facilis Spinal System
- K161275 — EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip
- K161823 — Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs
- K162606 — Elecsys TSH assay, cobas e 801 Immunoassay analyzer
- K162618 — CONCORD Plus Radiopaque Bone Cement
- K162962 — OrthAlign Plus System
- K163107 — Lifestyles Zero Lubricated Latex Male Condom
- K160589 — Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe
- K160660 — Medline Waste Station
- K161090 — Cranial PSI
- K161178 — da Vinci Xi Surgical System
- K161255 — meso-relle (AAL34, AAL36, AM30G)
- K161414 — Anatomic Total Knee System
- K161418 — Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set
- K161492 — Juno VPAP ST-A
- K161593 — GMI Frontier Dental Implant System
- K161650 — Polysmith Sleep System, Model NTI7593
- K162137 — Fever Scout Continuous Monitoring thermometer
- K162242 — Comfort Flo Humidification System
- K162397 — Titan 3 Low Speed Angle Attachments
- K162399 — Atellica CH Magnesium (Mg)
- K162430 — UniStrip1 Generic Blood Glucose Test Strips
- K162434 — NC Gallant PTCA Catheter
- K162472 — TrueBeam-TrueBeam STx-Edge
- K162764 — JAZZ FRAME SYSTEM
- K162932 — Ranfac Fat Aspiration Cannula
- K163069 — OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
- K163113 — Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series
- K163605 — LEDEX WL070+
- K163620 — Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves
- K153587 — Taps for Resorbable Screws
- K161091 — STIMPOD NMS460 Nerve Stimulator
- K161274 — Bondiloxs Topical Hemostatic Granules
- K161412 — F&P Brevida Nasal Pillows Mask
- K161904 — GEO Bone Screw System
- K162121 — Siconus SI Joint Fixation System
- K162197 — EndoClot
- K162432 — Multi-Link X2 ECG Cable and Lead Wire System
- K162651 — Breast BI 7 MR Coil Mammavention 3T
- K162817 — Noddle(TM)
- K162895 — Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5
- K163156 — SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides
- K163254 — Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens
- K163310 — NovaBone IRM
- K163657 — Quantum Workstation
- K161514 — Precision Thin Reciprocating Blade, 0.010in.
- K162455 — Humelock Reversed Shoulder
- K162663 — WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A
- K163231 — Chameleon PTA Balloon Catheter
- K163554 — hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test
- K153128 — Kolplast Cervical Sample Collection Kit
- K160965 — SuperLine
- K161106 — PANPAC DISPOSABLE VACUUM CURETTES
- K161328 — Cantab Mobile
- K161762 — DynaMatrix/Dynamatrix Plus
- K162164 — GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord
- K162489 — RED Light Device
- K162511 — LELO RESPECT HEX Natural Rubber Latex Condom
- K162775 — Legion Cone System
- K162864 — OsteoVation Impact
- K163519 — RX DC
- K163534 — Lumipulse G FSH-N Calibrators
- K163541 — Magseed Magnetic Marker System
- K163546 — Lumipulse G Progesterone-N Calibrators
- K161217 — VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)
- K161902 — Meridian M110 Fetal Monitoring System
- K162173 — Elecsys CYFRA 21-1 CalCheck 5
- K162323 — Tooth Shade Resin Material
- K162336 — Contour Next EZ Blood Glucose Monitoring System
- K162500 — Ostial Sprit Cannulae
- K162532 — WellDoc BlueStar, WellDoc BlueStar Rx
- K162694 — Ayers Rock Cervical interbody fusion system
- K162754 — FREND Vitamin D Test System
- K162884 — SpineGuard DSG Zavation Screw System
- K163176 — Exilis XP II
- K163205 — 48CH Head Coil
- K163521 — Lumipulse G LH Calibrators
- K163533 — EzDent-i; E2; ProraView
- K163544 — Lumipulse G Prolactin
- K163635 — ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems
- K160178 — Lympha-Flow(LF1200)
- K161204 — ENDOCAM Flex HD Camera System 5521
- K161281 — Dentalis Bio Solution Implants
- K161517 — Mortara Surveyor Patient Monitor
- K162057 — ConceptoMed Luer-Jack Slip 10ml
Data sourced from openFDA. This site is unofficial and independent of the FDA.