FDA 510(k) clearances — page 887
clearances on record, most recent first.
Clearances — page 887
88,601–88,700 of 175,890- K983132 — IGM
- K983140 — CT BIOPSYVIEW
- K983167 — TRF
- K983209 — SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I
- K983221 — IGG
- K983285 — ENGLE DENTAL FAMILY OF DELIVERY SYSTEMS
- K983304 — SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT
- K983356 — C4
- K983359 — IGA
- K983441 — C3
- K983507 — VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAY
- K983693 — DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR
- K983722 — STRATUS CS TROPONIN I CALIBRATOR
- K983857 — AUTOVENT 1500
- K981378 — DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1
- K981666 — 2.5 MM LACTOSORB SCREWS
- K981691 — SILICONE SOFT RELINE
- K981772 — HALOLITE AAD SYSTEM
- K981845 — HAWK ANAESTHESIA INDUCTION UNIT
- K981886 — VRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER
- K981950 — SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500
- K982016 — PIPER IPPB MODEL 2055
- K982454 — BIPAP VISION VENTILATORY SUPPORT
- K982748 — BI-POLAR CORD SET 1.88 TR, BI-POLAR CORD SET 1.83 TR, MODEL #'S SB223, SB 224
- K982769 — MITRA IMAGING INC. EXHIBIT
- K982773 — QUICKSET LIQUID AND POWDER
- K982775 — BAUSCH & LOMB RENU MULTI-PURPOSE SOLUTION
- K982870 — EPIFILM OTOLOGIC LAMINA
- K982878 — EARSCAN 3
- K982921 — MEDRAD 0.5T, 1.0T & 1.5T BREAST COIL, MODELS M21BRC, M42BRA, M64BRA
- K982959 — MEDRAD QUAD C-SPINE COIL, 1.5T MODEL, M64CSC, 1.0T MODEL M42CSC
- K983101 — BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24
- K983178 — COAMATIC HEPARIN
- K983206 — SMALL VAGINAL/RECTAL ELECTRODE
- K983247 — SUPER PORCELAIN ADDMATE
- K983294 — ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712
- K983394 — MODIFICATION TO TIELLE HYDROPOLMER DRESSING
- K983513 — VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
- K983562 — MASCOT MD HEMATOLOGY ANALYZER/ MODEL MD 700
- K983621 — NEEDLE GUIDE
- K980576 — VARIAN ENDOMETRIAL APPLICATOR FOR VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER
- K981600 — LATEX EXAMINATION GLOVES BUBBLE GUM FLAVOURED PRE-POWDERED
- K982611 — UNIJECT LATEX EXAMINATION GLOVES (POWDER FREE)
- K982713 — RT DESKTOP
- K982717 — SOMNOPLASTY SYSTEM, MODELS S2, 1010/2010,2000/1000,1100,3000/30XX/6000, 1200
- K982776 — 9303 NEONATAL/ADULT VITAL SIGNS MONITOR
- K982836 — CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM
- K982839 — CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300
- K982919 — MEDRAD QUAD T/L COIL (1.5T, 1.0T & 0.5T) MODELS M64TLC, M42TLC, M21TLC
- K982932 — MEDRAD ANTERIOR NECK COIL, 1.5T & 1.0T MODEL NUMBERS M64ANC AND M42ANC
- K982985 — CITREX HOSPITAL SPRAY DISINFECTANT
- K983069 — PHILIPS DUO DIAGNOST
- K983245 — POS-T-VAC (AVP-1000)
- K983246 — POS-T-VAC (IVP-600)
- K983619 — BARCHENS COMPANY DIGITAL PACIFIER THERMOMETER
- K973985 — AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU)
- K981034 — SILENT NIGHT II
- K981366 — STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES
- K981371 — LTV 1000 VENTILATOR
- K982766 — PASTE OPAQUE EX-3
- K983067 — FINE-JECT
- K983122 — MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KIT
- K983124 — MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KIT
- K983207 — SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K981096 — SEMPERMED SURGEONS' GLOVES - SUPREME
- K981497 — STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS
- K981508 — VECTORVISION SPINE MODULE
- K982131 — NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
- K982673 — JUST BETWEEN US, PERSONAL LUBRICANT & CONDOM
- K982675 — AIRWATCH II ZONELESS
- K982676 — AIRWATCH II ZONE
- K982789 — MEDICAL AIR COMPRESSOR, MODEL # 8413419
- K982824 — X-RAY TIMER MODEL I.E.D. 7888 I.D. 7881 AND B764ID
- K982834 — RESTGRID PACKAGE/GYROSCAN NT
- K982835 — ELECTRODE SWITCHBOX, MODEL 11-081002
- K982916 — MEDRAD 1.5T, 1.0T & 0.5T SHOULDER COIL, MODELS M64SHC, M42SHC, M21SHC
- K983273 — XCT 2000 L PQCT BONE DENSITOMETER
- K983436 — GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM
- K983447 — WISE (II) IMAGE MANAGEMENT SYSTEM
- K983643 — GENESIS BLS
- K983705 — EMT RESUSCITATOR
- K983785 — AUTOVENT 1000
- K973138 — SPIROCARD
- K974581 — MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT
- K980799 — HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL
- K981207 — CLEARPLAN EASY FERTILITY MONITOR
- K981528 — SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM
- K982082 — HANDISOL WOUND HEALING
- K982225 — SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504
- K982541 — VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608
- K982662 — DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW
- K982693 — MEDINE DISPOSABLE STERILE ZONED IMPERVIOUS SURGICAL GOWNS
- K982723 — MAICO MA42
- K982733 — OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE
- K982793 — PIEZO TRONIC
- K982810 — SHELHIGH NO-REACT VASCUPATCH
- K982970 — MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER
- K983080 — AUROLLOYD KF
- K983081 — BEGOPAL 300
- K983082 — BEGOCER G
Data sourced from openFDA. This site is unofficial and independent of the FDA.