FDA 510(k) clearances — page 609
clearances on record, most recent first.
Clearances — page 609
60,801–60,900 of 175,825- K062746 — FERRITIN-LATEX, MODELS 1418-2070, 1418-0279
- K062938 — MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH NITROFURANTOIN (2 - 256 UG/ML
- K063315 — INTELLIVUE PATIENT MONITORS, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90
- K061375 — RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730
- K061601 — ASAHI PRECIOUS GUIDE CATHETER
- K061829 — ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
- K062131 — NIO 5MP-M-21 (NIO 5MP MAMMO); MDNG-5121 BB
- K062399 — ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE
- K062416 — RETINAL FUNCTIONAL IMAGER (RFI)
- K062487 — APERFIX FEMORAL IMPLANT WITH INSERTER
- K062493 — LAVA SOFTWARE
- K062510 — AESCULAP STERILCONTAINER SYSTEM
- K062523 — TRU-MR LARYNGOSCOPE SET
- K062851 — OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDED
- K062906 — ENA HFO COMPOSITE SYSTEM
- K063046 — NITRILE POWDER FREE EXAMINATION GLOVES (GREEN)
- K063185 — RII INFRARED EAR THERMOMETER, MODELS TH5XY SERIES
- K063280 — INJEKT SYRINGE
- K063283 — DEFINIUM 5000 X-RAY SYSTEM
- K063373 — FLEX LOOP COIL SET 3T
- K063389 — GO GO ELITE TRAVELLER PLUS 4 WHEEL SCOOTER, MODEL SC54
- K052716 — RAPIRUN H. PYLORI ANTIBODY DETECTION KIT
- K053524 — C-PORT DISTAL ANASTOMOSIS SYSTEM
- K061933 — HAGER MIRAMATIC BOX SHARPS CONTAINER AND CAP TRAP NEEDLE RE-CAPPER
- K062123 — VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV
- K062400 — IMPRESSIX, COLORCHANGE ALGINATE
- K062643 — KINETIC ANTERIOR CERVICAL PLATE
- K062934 — SIERRA
- K063289 — 2MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-2NC
- K053420 — TENACORE SP02 SENSORS
- K061002 — MAXIMA ANTERIOR CERVICAL PLATE SYSTEM
- K062065 — RIVA LUTING PLUS
- K062419 — TRIDENT LARGE DIAMETER ACETABULAR INSERTS
- K062677 — ELI 350 ELECTROCARDIOGRAPH
- K062944 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (GN) 0.5-64UG/ML
- K063302 — SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES
- K062074 — IRIDEX WIRELESS FOOTSWITCH
- K062262 — CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS
- K062403 — IMAX CEPH DIGITAL X-RAY SENSOR
- K062441 — BARRX HALO COAGULATION SYSTEM; GENERATOR, MODEL 90-9000; OUTPUT CABLE, MODEL 90-9010; FOOTSWITCH, MODEL 90-9020
- K062619 — DENLASER 800 PLUS
- K062871 — LUMACARE LC-122M NON-COHERENT LIGHT SOURCE
- K063085 — MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM
- K063158 — SYNTHES ANTEGRA SYSTEM
- K063204 — SPIDERFX EMBOLIC PROTECTION DEVICE
- K063222 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004
- K063252 — ATB ADVANCED PTA DILATATION CATHETER
- K060544 — SALTO TALARIS TOTAL ANKLE PROSTHESIS
- K061696 — IQQA-LIVER SOFTWARE
- K061718 — INNOVACON SPECTRUM II TEST CARD
- K062434 — ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528
- K062898 — SBI LATERAL RHEAD IMPLANT
- K062908 — ORTHROPRO HEMI TOE
- K062920 — ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP
- K062984 — MEDLINE HYPODERMIC NEEDLES
- K063144 — VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM
- K060907 — KARL STORZ VIDEO GASTROSCOPES
- K061653 — SOYALA FULL FACE MASK
- K062064 — RIVA BOND LC
- K062109 — BINAXNOW INFLUENZA A & B TEST
- K062155 — DIGITAL MXR-D FLOWMETER
- K062161 — GORE PROPATEN VASCULAR GRAFT
- K062186 — ASAHI PTCA GUIDE WIRE, FIELDER J, MODEL AGP140000J, AGP140300J
- K062241 — ADJUSTABLE MULTI-CATHETER SOURCE APPLICTOR
- K062384 — CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE
- K062474 — SMITHWICK CAROTID SHUNT
- K062605 — PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T
- K062723 — HALO90 COAGULATION CATHETER
- K062733 — TOMAS PIN SD 6, 8, AND 10 MM
- K062782 — INION ANCHRON PLUS BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6001
- K062839 — MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
- K062884 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)
- K062955 — POWDER FREE LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
- K063081 — AEQUALIS SHOULDER SYSTEM
- K063102 — MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML)
- K063120 — COLOR LCD MONITOR, RADIFORCE, MODEL RX210
- K063207 — S-SCAN MRI SYSTEM
- K063241 — CSTC-002A, EXTENDED FIELD OF VIEW SOFTWARE OPTION
- K063266 — 3MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-3NC
- K063267 — ISITE PACS, V 4. X
- K061848 — HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU1
- K061905 — HORIZON CARDIOLOGY ECG-MCKESSON'S ECG MANAGEMENT SYSTEM, MODEL 1.0
- K061935 — SENSACARE SAW-102 WRIST DIGITAL BLOOD PRESSURE MONITOR
- K062127 — MEDIC4ALL TELEMEDICINE SYSTEM, MODEL VMS-01 (NIBP)
- K062228 — ZIMMER HIP COMPUTER ASSISTED SOLUTIONS ELECTROMAGNETIC AND IMAGELESS INSTRUMENTATION
- K062369 — IRIDEX OCULIGHT TX
- K062409 — K-ETCHANT GEL
- K062930 — LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
- K052599 — 66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A
- K052742 — HEPASPHERE MICROSPHERES
- K062043 — BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500
- K062135 — ART SHIELDED BREAST APPLICATOR
- K062422 — HUMERAL HEAD, MANUAL DRIVER
- K062440 — GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091
- K062757 — XERON PACS
- K063079 — I-STOP TRANS OBTURATOR MALE SLING
- K063093 — SECTRA WORKSTATION, VERSION 11.1
- K053225 — CELLU M6 KEYMODULE I
- K061908 — NICOLETONE SYSTEM V32 AMPLIFIER
- K062412 — CRYOMATIC
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