FDA 510(k) clearances — page 784
clearances on record, most recent first.
Clearances — page 784
78,301–78,400 of 176,637- K012820 — AIA-PACK CTNI 2ND-GEN ASSAY
- K013094 — ORTHOSONIX ENERGEX
- K013151 — ASMOTOM AUTOMATED TREPHINE SYSTEM
- K013200 — RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01
- K013282 — GORE INTRODUCER SHEATH
- K013293 — NIPRO HYPODERMIC NEEDLE
- K013327 — CTS-415
- K013401 — K-SYSTEMS CULTURE BAG SEALER AND CULTURE BAGS TYPE CBS-1 AND CB-01
- K013538 — ETHANOL
- K013541 — SHOULDER COIL
- K013703 — SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175M
- K013813 — MODIFICATION TO:APEX MEDICAL IF-4100
- K013866 — CONVOY ADVANCED DELIVERY SHEATH KIT
- K013939 — JOSTRA FLOWPROBE FP-32E
- K004008 — STRESS GUARD, MODEL HERDEV1
- K010526 — MODIFICATION TO THE GRIP
- K011454 — SPINE SCOPE, MODEL 2180
- K012378 — 3D HUMERAL HEADS
- K012686 — CAIRD TECHNOLOGY HOLTER 2000
- K013086 — WET LIGHT PERSONAL MOISTURIZER
- K013090 — SOPRO 67D OPERATING ROOM CAMERA
- K013092 — HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
- K013242 — AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM
- K013271 — DXS DIGITAL X-RAY SYSTEM
- K013334 — ENDOFLIP
- K013337 — PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI
- K013358 — DYNAPULSE 5000A MINI ABP BLOOD PRESSURE MONITORING SYSTEM
- K013367 — CARDIOCOLLECT PORTABLE ELECTROCARDIOGRAPH
- K013493 — INDIGO OPTIMA LASER SYSTEM
- K013516 — INVACARE ELEVATING SEAT OPTION ESS6
- K013528 — CRYSTAL 5000 PHASES ARRAY TMJ COIL
- K013739 — MODIFICATION TO EBI XFIX DFS SYSTEM
- K013801 — ULTRASAFE DENTAL INJECTION SYSTEM
- K013815 — MEDRAD QWIK-FIT SYRINGE
- K013842 — IMMUNO-TROL LOW CELLS
- K013935 — ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS
- K013992 — NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY
- K013069 — BIOSPEED
- K013070 — JAMSHIDI BIOPSY NEEDLE
- K013071 — SECURCUT ASPIRATION BIOPSY NEEDLE
- K013076 — SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR
- K013379 — SAS STREPALERT
- K013411 — PULPDENT CAVITY PREPARATION IV
- K013423 — MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS
- K013580 — SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE
- K013767 — SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN, FROM AN EXTERNAL INFUSION PUMP
- K013807 — MICROJET QUARK, MODEL U100 OR U40
- K003075 — KNIGHTSTAR 330 VENTILATOR
- K010388 — SONDREX P.A.L. SYSTEM
- K010443 — CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH X-COATING
- K012501 — H.M.T. ACUPUNCTURE NEEDLE
- K012583 — ACUGLIDE BRAND ACUPUNCTURE NEEDLES
- K012587 — RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE HANDLE, DISOISABLE HANDPIECE REUSABLE TELESCOPE
- K012762 — MJS POSTERIOR STABILIZED KNEE SYSTEM
- K013063 — GRIP LOCK ANCHOR, MODEL 411374
- K013066 — HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
- K013246 — DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01
- K013344 — INTERA I/T
- K013788 — TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5
- K013792 — MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
- K013890 — SURGICAL DYNAMICS MENISCAL STAPLE
- K001003 — Z-NET
- K011244 — ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM
- K011451 — REUNITE FUSION SCREW
- K011683 — NURVO 9000 ENDOCAVITARY COILS
- K011849 — MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS
- K012588 — OXOID PYLORI TEST KIT, MODEL DR0130M
- K013050 — THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
- K013060 — ICS MEDICAL MODEL VG-30 VIDEO GOGGLES
- K013400 — SYNERGY FLOW
- K013708 — REFERENCE CHECK, CATALOG NUMBER-RCN-10
- K013753 — DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
- K013804 — SOCRATES ROBOTIC TELEMONITORING SYSTEM
- K012186 — MASTER & FRANK SURGICAL GOWNS (STERILE)
- K013031 — MOST OPTIONS SYSTEM
- K013035 — GUARDIAN LIMB SALVAGE SYSTEM
- K013036 — NOMOS MOTORIZED CRANE II
- K013037 — EXCEL A.V FISUTAL NEEDLE SET
- K013040 — LIGHT SABER INTRODUCER NEEDLE
- K013055 — THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
- K013098 — KIMAX REMOTE VIEWING STATION
- K013146 — VIATRONIC V3D CALCIUM SCORING
- K013244 — COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE
- K013256 — BI-3M NEEDLE-FREE INJECTOR SYSTEM
- K013333 — LATEX EXAMINATION GLOVES POWDERFREE POLYMER COATED WITH PROTEIN CONCENT LABEL CLAIM
- K013537 — ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
- K013686 — KODAK DIRECTVIEW TABLETOP CASSETTE
- K013727 — STERILE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CLAIM LESS THAN 50 UG/G
- K013734 — MAS LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL 1 AND 2, DADE LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL
- K013878 — CYBERMED, INC., V-WORKS
- K013880 — DAYLITE XENON LIGHT SOURCES
- K993535 — METAPAK MULTI-PURPOSE INSTRUMENT TRAY
- K003324 — PLASMA SPRAYED SHOULDER
- K011893 — COSMETICA (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES
- K012337 — BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM
- K012631 — REPROCESSED SOFT TISSUE ABLATORS
- K013017 — MEDIGROUP KEY TUBE
- K013027 — MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123
- K013028 — PALOMAR SLP 1000
- K013047 — FOTONA DUALIS ND:YAG LASER SYSTEM, FOTONA TWINLIGHT ND:YAG LASER SYSTEM
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