FDA 510(k) clearances — page 811
clearances on record, most recent first.
Clearances — page 811
81,001–81,100 of 176,637- K003965 — MRI SAFE INSTRUMENTS
- K003995 — SPECULITE/ORALLITE
- K004014 — MD 30 COMPACT
- K010084 — REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RP
- K010206 — DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137
- K010218 — VISTAKON (HEFILCON C) CONTACT LENSES
- K010223 — BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT)
- K010266 — TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000
- K010287 — SCIMEDX PHASE II PR3 IGG ANTIBODY EIA
- K010298 — MN-4 COARSE MANIPULATOR
- K010409 — CBC-SF
- K010445 — PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM
- K010606 — SAFARI
- K010609 — ACCUSONIC, MODEL AS-260
- K002297 — YORAMED, MODEL T-202
- K002315 — WISEBANDS SKIN CLOSURE DEVICE
- K003267 — SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A
- K003301 — DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER
- K003344 — MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 2
- K003346 — RANDOX GLUCOSE (GOD/PAP)
- K003501 — N PROTEIN STANDARD UY CALIBRATOR
- K003557 — ACON THC ONE STEP MARIJUANA TEST STRIP(URINE); ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE)
- K003899 — IFIS-SA INTEGRATED FUCTIONAL IMAGING SYSTEM
- K003955 — LASEREX INTEGRE, MODEL LP2532
- K004050 — PANASONIC TELE-HOMECARE SYSTEM
- K010070 — ULTRAPAK NEHA
- K010085 — EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED)
- K010103 — SURSHIELD WINGED INFUSION SET
- K010116 — PLANMED SOPHIE, PLANMED SOPHIE CLASSIC
- K010351 — INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM
- K010425 — EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY)
- K010427 — LORENZ FIDUCAIL SCREW
- K010447 — MODIFICATION TO ACTICOAT FOAM DRESSING
- K010463 — DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES
- K010523 — MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST
- K010591 — OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER
- K010617 — SPIFE IFE CALIBRATOR AND CONTROL KIT
- K010631 — NEMIO
- K992706 — GALIX GBI -3S-LP
- K002382 — 'ALL 2000' % OXYGEN ANALYZER
- K010024 — O2/CO2 NASAL FILTERLINE
- K010061 — DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND
- K010191 — Y2000 POCKET RESCUE
- K010352 — CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM
- K010359 — INNOVO
- K010402 — SMOOTH-FLO CIRCUIT
- K010687 — BIOSORBFX AND BIOSORBPDX MESH
- K001353 — MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM
- K001354 — MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEM
- K002153 — ULTRASONIC NEBULIZER, MODEL NE-520
- K002862 — PRONEB ULTRA MODEL NUMBER 85B0100
- K003017 — GRAMSORB SYNTHETIC ABSORBABLE SUTURE
- K003173 — ASPIRE COVERED STENT AND DELIVERY CATHETER
- K003503 — N LATEX CYSTATIN C
- K003614 — LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM
- K003746 — 3D-DOCTOR
- K003911 — TERRAY STAINLESS STEEL ROD (STRAIGHT, L, RECTANGLE)
- K003947 — FUNCTIONAL BRAIN MAPPING OPTION FOR MRI
- K004015 — BEAM BLOCK TRAYS
- K010062 — STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM
- K010373 — SIMPLICITY SOFT Y INFUSION SET FOR USE WITH THE MINIMED INFUSION PUMPS AND MINIMED MEDICATION RESERVOIRS (MODEL MMT-103)
- K010405 — 7230 ULTRASOUND IMAGING SYSTEM WITH TEI
- K010428 — ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349
- K010434 — OPTETRAK B-SERIES TOTAL KNEE SYSTEM
- K010437 — MODIFICATION TO EBI XFIX DFS RAIL SYSTEM
- K010562 — ALPHA DX SYSTEM
- K003837 — FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM
- K010082 — D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM
- K010126 — PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)
- K010165 — ERO SCAN OAE TEST SYSTEM
- K010391 — ATLAS MULTI-PURPOSE DSA SYSTEM
- K010392 — ATHENA REMOTE CONTROLLED RF SYSTEM
- K010393 — APOLLO MOBILE C ARM SYSTEM
- K010435 — PHILIPS BV PULSERA/ENDURA
- K010548 — MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
- K010572 — BD VISIDRAPE OPHTHALMIC DRAPES; BD VISIFLEX INCISE DRAPE
- K002150 — SONICAID FM820, SONICAID FM830
- K003299 — OPD-SCAN, MODELS ARK-10000 AND ARK-9000
- K003594 — CARRIAZO BARRAQUER SINGLE USE MICROKERATOME
- K003816 — ARTHREX TITANIUM CORKSCREW, 3.5 MM, ARTHREX TITANIUM CORKSCREW, 5.0 MM, ARTHREX TITANIUM CORKSCREW 6.5MM
- K003867 — EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET)
- K010040 — SLEEVED FILTER
- K010182 — VCF PERSONAL LUBRICANT
- K010367 — MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM
- K010390 — ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS
- K010495 — CENTURA PHOTOTHERAPY SPOTLIGHT
- K010505 — TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY
- K010521 — NICOLET VERSALAB
- K000881 — PERFADEX SOLUTION FOR ORGAN PRESERVATION
- K002907 — PVS 1300 NEURO GUIDE WIRE
- K003058 — LASER 3 SPSC300
- K003369 — LIFECARE COMPACT TENS DEVICE
- K003787 — NEWTOM QR-DVT 9000
- K003820 — DISPOSABLE CB-PE MICROKERATOME BLADES
- K003824 — OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI
- K003826 — FOCUS DAILIES PROGRESSIVES
- K003861 — BENZ-MF (VISIBILITY HANGLING TINT) (METHAFILCON A) SOFT DAILY WEAR CONTACT LENS (LATHE-CUT)
- K003908 — SEROJET
- K004034 — MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12
- K010416 — HERACERAM 75
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