FDA 510(k) clearances — page 859
clearances on record, most recent first.
Clearances — page 859
85,801–85,900 of 175,890- K991738 — DIGITAL VIDEO RECORDING SYSTEM
- K991794 — ENDOSCOPIC SPINAL ACCESS SYSTEM
- K991815 — EXPLORER 3D
- K991893 — PARALLAX TRACER RADIOPAQUE PARTICLES
- K991921 — INTERMITTENT COMPRESSION BOOT FOR OTC
- K991958 — KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT
- K991960 — SERFAS, SERFAS GENERATOR, SERFAS CONSOLE, SERFAS PROBE, SERFAS HANDPIECE CABLE, SERFAS FOOTSWITCH
- K991972 — INFANT FLOW SYSTEM
- K992025 — PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING
- K992046 — SONOLINE 7XX DIAGNOSTIC ULTRASOUND SYSTEM
- K992120 — DYNAWELL OR DYNAWELL
- K992336 — MONARCH II MINI MASK
- K992439 — NORODYN 8000 SEMG SYSTEM, ND-8000
- K992462 — OSTEONICS UNIVERSAL DISTAL CEMENT PLUG
- K982724 — THERADYNE ROVER POWERED WHEELCHAIR
- K982969 — NONIN PULSE OXIMETER AND CARBON DIOXIDE DETECTOR, MODELS 9843, 9845 AND 9847
- K983395 — FETALGARD 3000 FETAL MONITOR
- K984304 — RIWO DRIVE GENERATOR
- K984567 — VENTANA ER PRIMARY ANTIBODY (CLONE 6F11)
- K984569 — AB2 MED-FLO SOLUTION SET
- K990428 — DRAINAGE BAG
- K990440 — GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE
- K990907 — REMOTE INTRODUCER, MODEL PI-1000
- K991669 — PMS 750 FINGERSWITCH
- K991674 — CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODELS PC155BJS, PCI156BJS, PC185BJS, PC186BJS
- K991678 — WHITESIDE BIOMECHANICS SPINAL SYSTEM
- K991718 — OPERATING LAPAROSCOPE, 10-5 MM, ANGELED, OPERATING LAPAROSCOPE 12-7MM, ANGLED, OPERATING LAPAROSCOPE, 10-5,,. OBLIQUE, D
- K991757 — NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE
- K991791 — SOUND VASER SYSTEM
- K991792 — CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBE
- K991820 — HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI
- K991889 — ULTIMAX HAIG II NAIL SYSTEM
- K991895 — RAMPIPELLA, SINGE PORT (720196) & WEDGE-SHAPED PORT (720217)
- K991920 — DERMAPHYLYX HYDROPHILIC FOAM WOUND DRESSING
- K991931 — CTD MARK I TRACTION DEVICE
- K991949 — LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDERED)
- K991950 — LAGLOVE BRAND NITRILE SURGICAL GLOVE-STERILE (POWDER-FREE)
- K992029 — ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
- K992035 — MANUAL WHEELCHAIR
- K992052 — MODELS LYNX AND PANTHER MOTORIZED SCOOTERS
- K992109 — ENCORE FULLY COATED HIP
- K992346 — KINEMATIC II ROTATING HINGE KNEE
- K992363 — SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THIN
- K992473 — EXPRESSEYE
- K992499 — GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLE
- K992514 — CONVERTORS BREATHABLE SURGICAL GOWNS
- K983333 — BUFFALO FILTER VIROSAFE HRF- #VSHRFO1
- K983364 — BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801
- K990545 — JETSONIC 2000
- K991268 — GONOSTAT GONOCOCCAL DETECTION KIT
- K991481 — PARAGON
- K991776 — NITRILE EXAMINATION GLOVES POWDER FREE (WHITE)
- K991779 — NITRILE EXAMINATION GLOVES POWDER FREE (BLUE)
- K991839 — ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER
- K992550 — LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, 3
- K984214 — CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER
- K984530 — DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE
- K990648 — KELLER VITAL SIGNS MONITOR, KMS 890+
- K990883 — LAGLOVE BRAND BLUE COLOLRED NITRILE EXAMINATION GLOVE (POWDERED)
- K991632 — FOTONA NOVALIS ER: YAG LASER SYSTEM
- K991634 — FOTONA NOVALIS R RUBY LASER SYSTEM
- K991665 — HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01
- K991701 — MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD)
- K991717 — CARESIDE MG
- K991766 — ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A
- K991826 — PLANMED SOPHIE AND SOPHIE CLASSIC
- K991938 — CAPHOSOL ARTIFICIAL SALIVA
- K992051 — RADIFOCUS OPTITORQUE
- K992252 — LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965
- K992365 — AIA-PACK FOLATE ASSAY
- K992422 — ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/OPI2000; STATUS DS COC/THC/OPI2000
- K992503 — SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES
- K984532 — CADPLAN HELIOS OPTION 6.0
- K990263 — IMMUNOCARD STAT! E. COLI O157:H7
- K990842 — SAS ROTA TEST
- K991316 — TOUCH TEAR IGE MICROASSAY KIT
- K991623 — NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERIO-VENOSA, AGUJA PARA FISTULA ARTERIO VENOSA
- K991628 — MODIFIED LX-20 CO2 LASER SYSTEM FAMILY, LX-20SA
- K991720 — KRONUS OPTIQUANT THYROGLOBULIN KIT
- K991890 — AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA
- K991961 — 3M LVR SYSTEM
- K992138 — MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES
- K992428 — ACCUTOUCH POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE
- K990666 — HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELL
- K991284 — ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM
- K991715 — BIOSTINGER-V BIOABSORBABLE MENISCAL REPAIR DEVICE
- K991788 — SALTER LABS PEP DEVICE
- K991790 — ULTIMAX ANKLE FUSION ROD SYSTEM
- K991806 — VHS SUPRACONDYLAR PLATE SYSTEM
- K991877 — MACMED PAEDIATRIC INTRAMEDULLARY NAIL
- K992040 — FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES
- K992229 — MXU-125 OR TMX-125
- K992291 — H20- TETHERED OPTION
- K992406 — VAPR 2.3MM END EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM
- K983618 — DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATE
- K984029 — SILGEL STC-S
- K984085 — RITEFLO SPACER
- K990041 — UROSTYM BIOFEEDBACK AND STIMULATION PROBES
- K991216 — HOFFMAN IVF-1
- K991261 — ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLDING MICEOPIPETTE, ASSISTED HATCHING/ZONA DRILLING MICROPIPET
Data sourced from openFDA. This site is unofficial and independent of the FDA.