FDA 510(k) clearances — page 601
clearances on record, most recent first.
Clearances — page 601
60,001–60,100 of 176,637- K070739 — ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500
- K070825 — LD8 DIGITAL WRIST BLOOD PRESSURE MONITOR
- K070887 — ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS)
- K070910 — SYSMEX MODEL UF1000I
- K071018 — MONARCH NASAL IMPLANT
- K071075 — TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A
- K071152 — PALOMAR ERBIUM HANDPIECE
- K071173 — RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D
- K071215 — VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927
- K071216 — VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2721, 195 7927
- K071222 — INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES
- K071331 — VITREA VERSION 4.0
- K062192 — OSTIAL PRO STENT POSITIONING SYSTEM
- K063743 — RHYTHM TOUCH Q 2-WAY
- K070431 — WELMED, INC. SURGICAL GOWNS
- K070456 — MICRUS COURIER ENZO MICROCATHETER 0.017
- K070595 — SPORVIEW STEAM SELF-CONTAINED BIOLOGICAL INDICATOR
- K070801 — IMM HYPODERMIC NEEDLE SET
- K070905 — ENDOSSEOUS DENTAL IMPLANT SYSTEM
- K070931 — MODEL PMT850
- K070974 — LIGHT RELIEF, MODEL LR150, LR200
- K071014 — MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR
- K071108 — TEXIUM SYRINGE
- K071301 — ANTLIA I WOUND IRRIGATION SYSTEM
- K071355 — SMARTSPONGE SYSTEM
- K061323 — MODIFICATION TO RELIADENT DENTAL IMPLANT SYSTEM
- K063269 — 5MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2010-5NC
- K063367 — 45L CORE INSUFFLATOR, MODEL F114
- K063489 — STRYKER INTRADISCAL RF GENERATOR
- K063611 — SALINE/ CONTRAST MEDIA INFUSION CATHETER
- K063873 — ICARE TONOMETER TA01I
- K070050 — VITALITY HIP SYSTEM MODEL#420
- K070116 — POWER PORT-A-CATH AND POWER PORT-A-CATH II; IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS NEEDLE
- K070124 — GASTROSTOMY REPLACEMENT TUBE, MODEL 253
- K070473 — BLOOD PRESSURE MONITOR, MODELS ZSBP-OXX AND ZSBP-1XX
- K070557 — MP 719
- K070807 — CUTANEOUS ELECTROTHERAPY AND RECORDING ELECTRODES; TENS ELECTRODES
- K070971 — MODIFICATION TO SENTINEL CLIN CHEM CAL
- K071135 — DEPUY CI HIP INSTRUMENTATION
- K071243 — METAL HEMI IMPLANT
- K062825 — AOS MARKER SEEDS
- K062826 — AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS
- K063480 — STRYKER RF INTRADISCAL ADAPTOR, MODEL 406-750
- K070064 — AMYLASE EPS REAGENT
- K070234 — JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS
- K070286 — BIO-CONSOLE, MODEL 560
- K070396 — MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45
- K070763 — EUROIMMUN ANA IFA: HEP-20-10
- K070827 — KARL STORZ SCB INTERFACE CONTROL, MODEL 20090120
- K070831 — VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION
- K070920 — FUJI IP CASSETTE TYPE PC
- K070934 — PANOSOL II TRU-BLU, MODEL UBL-417
- K070956 — SEA2 SELF ETCH ADHESIVE
- K071005 — HEARTWAY LIGHTWEIGHT POWER CHAIR, P15
- K071040 — WRIGHT MODEL 51 AND 52 SEQUENTIAL COMPRESSION SYSTEMS
- K071054 — RADIODEXTER, DEXTROSCOPE, DEXTROBEAM, MODELS 1.0, MK10, MK3 & MK4
- K071078 — .DECIMAL RANGE COMPENSATOR
- K071099 — NEURO II-SE, MODELS: OR-DR-OR, OR-MB
- K071114 — SYNGO IMAGING (VERSION V30)
- K071311 — NEOCOIL 1.5T 8-CHANNEL SHOULDER ARRAY COIL
- K071314 — SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS
- K063494 — DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS
- K070295 — SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM
- K070536 — MEDILAS D FAMILY LASERS
- K070759 — POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM
- K071006 — HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1
- K071076 — SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS
- K071188 — MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM
- K062563 — FEMTEN CERVICAL TENACULUM
- K063668 — ROC LUMBAR SYSTEM
- K070047 — NUNC IVF DISHES AND NUNC IVF 4-WELL DISH
- K070180 — WALLABY 4
- K070235 — BODYGUARD PAIN MANAGER INFUSION SYSTEM
- K070562 — EZ PLUS IMPLANT SYSTEM
- K070565 — COFIELD TOTAL SHOULDER SYSTEM
- K070688 — NEXFIX COMPRESSION STAPLE
- K070834 — CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS)
- K070964 — KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM
- K070990 — APEX MEDICAL MOBINEB, 9R-027 SERIES
- K071077 — .DECIMAL APERTURE
- K071095 — ASPIRA PLEURAL DRAINAGE SYSTEM
- K071117 — MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS
- K071204 — SITE-RITE 6 ULTRASOUND SYSTEM, MODEL SITE-RITE 6
- K071229 — SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPY
- K071267 — PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMIN
- K063806 — SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED
- K070284 — FRALEX SR 1500 LASER SYSTEM (FRALEX II SR LASER SYSTEM)
- K070645 — SERADYN QMS TOPIRAMATE
- K071091 — MODIFICATION TO BILOK SCREW
- K071115 — MODIFICATION TO BILOK ST SCREW
- K071217 — BLADDERSCAN BVI 9400 ULTRASOUND
- K071231 — EDAC QUANTIFIER
- K062525 — REPROCESSED LIGASURE VESSEL SEALER/DIVIDER
- K063104 — FOX MEDICAL DIODE LASER SYSTEM 810NM
- K063764 — SOUTHERN SPINE ANTERIOR CERVICAL STABILIZATION SYSTEM, KWIK- FIX CERVICAL SYSTEM, AND KWIK-FIX / TS CERVICAL SYSTEM
- K070024 — THOR VR SINGLE DIODE LASER TREATMENT PROBE, MODEL 200 MW SINGLE VR DIODE PROBE
- K070457 — SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFAB
- K070724 — IOS EXTERNAL FIXATOR, MODEL 2-0-0
- K070758 — STRYKER PEEK ZIP SUTURE ANCHOR
- K070885 — UNIVERSAL TAPER DELTA FEMORAL HEAD
Data sourced from openFDA. This site is unofficial and independent of the FDA.