FDA 510(k) clearances — page 385
clearances on record, most recent first.
Clearances — page 385
38,401–38,500 of 175,770- K140461 — MACH LED 2MC
- K132021 — AHP 300, EMERGENCY PORTABLE VENTILATOR
- K132483 — INNESIS PEEK CERVICAL CAGE
- K133933 — INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
- K140257 — SIGNATURE PLANNER, SIGNATURE GUIDES
- K131140 — OMNYX IDP FOR HER2 MANUAL APPLICATION
- K133606 — N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE ACL TIBIAL IMPLANT, VARIOUS CLASS I ANCILL
- K133939 — MODIFIED DISTAL RADIUS PLATING SYSTEM
- K140199 — VUPAD
- K140259 — VARIAX CLAVICLE HOOK PLATE
- K140271 — TABLET VIEWER SOFTWARE FOR IMAGE SUITE
- K140414 — IMBIBE NEEDLE
- K140420 — VADO STEERABLE SHEATH
- K140541 — IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C
- K131848 — VASHE WOUND SOLUTION (4.0 OZ), (8.5 OZ & (16.0 OZ)
- K131984 — SYNTHES SYNSONIC ULNA NAIL
- K132850 — BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM
- K133721 — INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL 44-TLIF CONTOUR OBLIQUE AND THE INFILL 60
- K134033 — MIROMATRIX BIOLOGICAL MESH
- K134044 — EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM
- K140505 — ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL
- K140584 — ICEROD CX CRYOABLATION NEEDLE
- DEN130040 — IOGYN SYSTEM
- K122298 — AJEX 1200 H / AJEX 240H MOBILE X-RAY GENERATOR
- K130263 — STERRAD 50/100S/200 TEST PACK
- K131075 — X-RAY TV SYSTEM SONIAL VISION G4
- K131861 — DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES
- K132572 — I-HIP TOTAL HIP SYSTEM
- K132988 — VITAL COUGH
- K133116 — VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC - RADEL), VIDEO ARTHROSCOPE TRAY (PLASTIC
- K133170 — QUICK JET M
- K133174 — ORTHOSCAN FD MINI C-ARM
- K133210 — B&B BUBBLER
- K133344 — MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS
- K133408 — NEUROSTAR TMS THERAPY SYSTEM
- K133515 — PEEK FUSION IMPLANT
- K133540 — FLOCAP
- K133560 — ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM
- K133636 — EXTREMITY MEDICAL HAMMERTOE DEVICE
- K133940 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)
- K133984 — CORONIS 5MP
- K134016 — ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER
- K140201 — AXERA 2 ACCESS SYSTEM
- K130603 — PATHFAST CTNL CALIBRATORS
- K132002 — SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR
- K132373 — BIOMET ACCESS SYSTEM
- K133004 — VENTED MILLEX -GV, CATHIVEX -GV
- K133455 — CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC
- K133493 — SINGLE USE STERILE SYRINGE WITH NEEDLE
- K133631 — LEXIPLIANT DILATOR SHEATH SET
- K133719 — PDE-NEO
- K133930 — FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET
- K140106 — S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
- K140485 — MANDREL GUIDEWIRE
- K140534 — ELECSYS PRECICONTROL TS
- K131760 — WHIP MIX PREPPIES PLUS
- K131939 — AMICO DH-W35 OPHTHALMOSCOPE SERIES
- K132320 — INTELLIVUE CL RESPIRATION POD
- K132759 — VENTRAIN
- K133508 — RESOLUTIONMD MOBILE
- K133539 — TOTAL ACROSS
- K133544 — OP300
- K133599 — CORGRIP
- K133680 — ENCORE SYSTEM
- K133775 — EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKING
- K133807 — MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT
- K140029 — AMIPLIVUE HSV 1&2 ASSAY
- K140300 — COLLAGEN TENDON SHEET-DDI (CTS-DDI)
- K140415 — MONOTEX
- K140637 — PEREGRINE SYSTEM INFUSION CATHETER
- K131703 — NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM
- K132017 — HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUIT
- K132965 — SOLACE SOUND GENERATORS
- K133640 — ASIR-V
- K133663 — NIO COLOR 2MP
- K133673 — ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA
- K133972 — ASPIRE CRISTALLE
- K133993 — CAAS WORKSTATION
- K140079 — SILEX SACROILIAC JOINT FUSION SYSTEM
- K140137 — SAFETY BIOPSY NEEDLE SYSTEM
- K140393 — RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3
- K140449 — CD HORIZON SPINAL SYSTEM
- K140452 — VEGA KNEE SYSTEM
- K140457 — NAUTILUS SPINAL SYSTEM
- K130550 — RSP MODULAR GLENOID BASEPLATE, GLENOID TAPER ADAPTER, RETAINING SCREW
- K132250 — INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM
- K132656 — PRODENSE BONE GRAFT SUBSTITUTE
- K133125 — WITHINGS BLOOD PRESURE MONITOR
- K133232 — PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA INCISION MANAGEMANT SYSTEM WITH PEEL& PLACE DRES
- K133382 — QB TEST
- K133453 — IOVERA
- K133593 — T:SLIM INSULIN DELIVERY SYSTEM
- K133974 — VARIAX DISTAL RADIUS PLATING SYSTEM
- DEN130049 — SIMPLEXA HSV 1&2 DIRECT
- K131553 — XTRA
- K131652 — LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
- K131877 — SAVE II, SAVE II BASIC
- K132011 — APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SET
- K132031 — AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL
- K132104 — ELIBRA SOFT-TISSUE FORCE SENSOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.