FDA 510(k) clearances — page 392
clearances on record, most recent first.
Clearances — page 392
39,101–39,200 of 176,542- K133903 — BIO-PROBE TRANSDUCER (ADULT)
- K140042 — 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME
- K140339 — VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
- K140473 — DUALGUARD
- K140648 — ST AIA-PACK C-PEPTIDE II CALIBRATOR SET
- K140696 — STREAMLINE TL SPINAL FIXATION SYSTEM
- K123555 — KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY
- K131098 — EMERGENCY PORTABLE VENTILATOR
- K131563 — SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM
- K131855 — PENTAX VIDEO COLONOSCOPES (EC FAMILY)
- K132009 — CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM
- K132401 — MEGA ISQ
- K133182 — HTFX-222
- K133212 — ZELTIQ COOLSCULPTING SYSTEM
- K133285 — STRYKER TEMPORARY CONDYLAR PROSTHESIS
- K133716 — TRC-PASTE
- K133837 — VIORA V-TOTAL
- K134008 — MD-FLEX HEAVY BODY
- K140047 — LEXICONTURE MECHANICAL DILATOR SHEATH SET
- K140609 — RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS
- K130171 — FLIGHT 60 VENTILATOR
- K130456 — WUNDER PREGNANCY TEST
- K130531 — ULTRAFUSE
- K132423 — THE GYNOCULAR
- K133366 — ORTHROS POSTERIOR STABILIZATION SYSTEM
- K133554 — SURGICAL LIGHT HANDLE COVER
- K133949 — POWDER FREE NITRILE PATIENT EXAMINATION GLOVE,BLUE AND ORANGE COLORED,NON-STERILE TESTED FOR USE WITH CHEMOTHERAPY DRUGS
- K140089 — CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO)
- K140482 — MANDREL GUIDEWIRE
- K132902 — SYNGO DUAL ENERGY SOFTWARE PACKAGE
- K133155 — HYDROPHILIC COATED GUIDEWIRE
- K133235 — THREADED PEEK K-WIRE
- K133743 — BAXANO SURGICAL MIS SPINAL SYSTEM
- K133844 — SPEED TRIAD
- K140007 — ABACUS TM SPACER SYSTEM
- K140069 — LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0
- K140372 — FRAGMENT PLATE SYSTEM
- K130014 — A1C GEAR SYSTEM
- K130878 — CLOUDEKG
- K130959 — AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GEL
- K132381 — CLEARMRI HELIOS-RG8 COIL ACCESSORY KIT
- K132911 — I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREW
- K133377 — NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT REPLACE
- K133470 — BARD RITECATH INTERMITTENT CATHETER
- K133572 — ARIA RADIATION THERAPY MANAGEMENT
- K133669 — MEDINAUT KYPHOPLASTY SYSTEM
- K133777 — TORNIER INSITE(TM) FT PEEK KNOTLESS SUTURE ANCHOR
- K133873 — TRIBALL INCENTIVE SPIROMETER
- K133910 — NORDICBRAINEX
- K133936 — ARTUS C. DIFFICILE QS-RGQ MDX KIT
- K140018 — TSP HIP FRACTURE PLATING SYSTEM
- K140315 — US ENDOSCOPY DISTAL ATTACHMENT CAP
- K140702 — 8MP COLOR LCD MONITOR, RADIFORCE RX850
- DEN130016 — XSTAT
- K130757 — KOBOLD SECURE LOCK TRANSFER GUIDE TUBE SET; KOBOLD LUER TRANSFER GUIDE TUBE SET
- K131202 — MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35X
- K131541 — FLEXIBLE COOAGEN NERVE CUFF
- K132105 — PERCLOT TOPICAL
- K132447 — VITALCONNECT PLATFORM BY VITAL CONNECT INC.
- K132488 — ZOLL CODE WRITER
- K132914 — ACUITY PRO LEAD DELIVERY SYSTEM
- K133139 — VIZION ULTRA
- K133614 — ALEUTIAN IBF SYSTEM
- K133834 — DEPUY GLOBAL UNITE SHOULDER SYSTEM
- K133914 — VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE
- K140003 — COROENT SMALL INTERBODY SYSTEM
- K140043 — DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD
- K140072 — CRYOTOP(R) SC
- K140131 — SUB-Q SUBCUTANEOUS TISSUE INFUSION SET
- K140376 — VARIAX 2 SYSTEM
- K140402 — MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SET
- K140460 — MACH LED 2SC
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.