FDA 510(k) clearances — page 688
clearances on record, most recent first.
Clearances — page 688
68,701–68,800 of 175,825- K041385 — MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM
- K033819 — INVACARE 3G TARSYS
- K033985 — PERIPATCH SLEEVE, MODELS G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10
- K040559 — MODIFICATION TO UNITY NETWORK ID
- K040604 — INNERVUE DIAGNOSTIC SCOPE SYSTEM
- K040610 — VERSA-DIAL HUMERAL HEAD
- K040611 — MODULAR RADIAL HEAD REPLACEMENT DEVICE
- K040613 — EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS
- K040654 — SENSILASE PAD 3000
- K040683 — BIODERM SCIENCES WOUND DRESSING
- K040699 — LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS)
- K040789 — DURABRAID SUTURE
- K040868 — SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH
- K041048 — POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE
- K041179 — MODIFICATION TO THE NAC PLUS NEEDLELESS ACCESS CONNECTOR
- K041235 — PHILIPS MP20, MP30, MP40, MP50. MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS
- K041347 — MODIFICATION TO EN-BLOC BIOPSY SYSTEM
- K041401 — MODIFICATION TO M2376A DEVICELINK SYSTEM
- K032767 — LILY VOLUME METERIC ADMINISTRATION SET, MODELS IB-2111 AND CIB-120ES
- K033512 — PROCYON SPINAL SYSTEM
- K033711 — FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM
- K033743 — COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT
- K033790 — THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES
- K040071 — ENNOBLE DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN
- K040149 — PSI-TEC PERISTALTIC INFILTRATION PUMP
- K040407 — QUICKELISA ANTHRAX-PA KIT
- K040458 — MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
- K040589 — MODIFICATION TO AVANT 9600 PULSE OXIMETER
- K040650 — BONAMATES SERIES
- K040681 — SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
- K040712 — AIR SAFETY HEPA, MODEL 3500
- K040720 — SURGASSIST COMPUTER MEDIATED LINEAR CUTTER DIGITAL LOADING UNITS, 30 MM, 55 MM, 75 MM
- K040726 — VENTLAB NASAL CPAP CANNULA
- K040790 — MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS
- K040791 — POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
- K040834 — NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000
- K040944 — RESCONTROL II
- K040994 — COSMEDENT CORE PASTE
- K041201 — ULTRACLIP II MR
- K041341 — GOLDEN SPYDER, MODEL GS-300
- K033489 — AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN
- K033859 — BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY
- K040391 — TOTAL BILIRUBIN REAGENT SET
- K040642 — LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINA
- K040655 — SWIFT ANTERIOR CERVICAL PLATE SYSTEM
- K040729 — SOLARIS D890 THERAPY PROBE
- K040748 — ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM
- K040966 — MODIFICATION TO CAREMATIX WELLNESS SYSTEM
- K041134 — COMBOMAP PRESSURE AND FLOW SYSTEM
- K041203 — SUMMIT OCT SPINAL SYSTEM
- K041240 — SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED
- K032983 — SENSITIVE SKIN ANTIBACTERIAL BANDAGES
- K033048 — CAS 740 SERIES MONITOR, MODELS 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS
- K040395 — CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES
- K040615 — COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM
- K040659 — MCCUE PLC ENERGIST ULTRA VARIABLE PULSED LIGHT SYSTEM
- K040713 — MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEM
- K040869 — EXPORT CATHETER
- K040919 — NUCLEOTOME PROBE SET, MODEL 21200
- K041188 — GRAND WORK PLASTICS PRODUCTS CO., LTD., SYNTHETIC VINYL PATIENT EXAMINATION GLOVES - POWDERED
- K041198 — NIC36 AMPLIFIER
- K041199 — MEDI-PUMP ASPIRATOR, MODEL 1615
- K030474 — PH BUFFERING PLASTIC APPLICATOR TAMPON
- K032170 — TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000
- K032522 — TECRES SPACER-K TEMPORARY KNEE PROSTHESIS
- K032644 — KOLPEXIN SPHERE
- K033458 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST
- K033971 — SCORPIO TOTAL KNEE SYSTEM WITH PERI-APATITE COATING
- K040265 — LITTLE GRAFTER SCREW
- K040293 — HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY
- K040544 — DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062
- K040552 — MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130
- K040664 — OMNILIGHT VL-2004, PL-2004, DL-2004, AND WL-2004
- K040758 — MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT
- K040891 — KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES)
- K040964 — SCORPIO TOTAL KNEE SYSTEM - POSTERIOR STABILIZED TIBIAL INSERTS
- K041114 — PROFEMUR TAPERED HIP STEM
- K041115 — GII QUICKANCHOR PLUS
- K041116 — SUPER QUICKANCHOR PLUS
- K041117 — PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732
- K041118 — MODIFICATION TO CD HORIZON SPINAL SYSTEM
- K041217 — MODIFICATION TO BONE GRAFT WASHER
- K041283 — PROCERA BRIDGE ZIRCONIA
- K041337 — PRO WALKER ML-300 FOLDABLE WHEELCHAIR
- K041358 — VENOJECT LUER ADAPTER
- K031738 — SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER
- K032397 — DUAL YELLOW LASER, MODEL DUAL YELLOW D10B
- K032897 — C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96
- K033663 — SPINAL CONCEPTS INC. CODA
- K033704 — MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS
- K040090 — COMPPAC 200HD; CS12 POWER SUPPLY (AIRCRAFT/VECHILE); PS11 POWER SUPPLY (MAINS)
- K040411 — DRI OXYCODONE ASSAY
- K040512 — LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401
- K040581 — MEDVIZERTM VITELCARE PATIENT MONITORING SYSTEM
- K040672 — PORTA REFLEX
- K040914 — POLYVIAL/POLYPAK, CONTACT LENS CASE AND STORAGE SYSTEM CONTAINER FOR OPHTHALMICS
- K041160 — AVON EXTRA-SMALL PATELLO-FEMORAL REPLACEMENT
- K041227 — MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA
- K041267 — CARDIQ ANALYSIS III
- K041270 — CT COLONOGRAPHY II
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