FDA 510(k) clearances — page 874
clearances on record, most recent first.
Clearances — page 874
87,301–87,400 of 176,637- K984141 — GBACT + KIT
- K990247 — MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470
- K990488 — SENSIFLEX POWDERFREE LATEX EXAMINATION GLOVE
- K990734 — DPD-12PCC
- K990736 — GC RELINE SOFT/EXTRA SOFT
- K990844 — STARDENTAL AXCS STERILE WATER SYSTEM
- K991088 — VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE
- K991156 — GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM
- K991158 — LATEX EXAMINATION GLOVES- POWDER FREE, SIZES EXTRA SMALL, SMALL,MEDIUM,LARGE,EXTRA LARGE
- K991175 — MODIFICATION TO ALCYON DIRECT BILIRUBIN
- K991299 — MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI
- K991430 — SMARTPREP CENTRIFUGE SYSTEM
- K991462 — QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED
- K991515 — INSURE PREGNANCY TEST
- K991528 — MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR
- K991612 — STERISHARP 2.5-GALLON RSDC, MODEL #RSDC2.5G
- K991640 — HEALTH AID PREMIUM PRE-POWDERED NITRILE EXAMINATION GLOVES
- K991648 — REUSABLE CONTOUR II NASAL MASK
- K991661 — SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
- K983551 — CRIT-SCAN II MONITOR
- K983604 — INTRA-UTERINE TRANSFER, INTRA-FOLOPIAN TRANSFER
- K984614 — NORMAL SALINE FLUSH SYRINGE
- K990015 — ELECTRODE NEEDLES
- K990432 — SURGISORB
- K990663 — INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY, MODEL FP880-150
- K990721 — ISOLOCK SPINAL SYSTEM
- K990753 — GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER
- K990875 — DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING
- K990891 — DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING
- K990902 — MODIFICATION OF MLT R694 RUBY LASER SYSTEM
- K990908 — MILLENNIUM
- K990968 — E-SCAN
- K991527 — CHROMOPHARE D500, D530, D650
- K991635 — MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
- K991703 — STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM
- K981246 — BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730)
- K983805 — THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO
- K984120 — THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH
- K984135 — THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
- K984169 — DIGI-SNAP
- K984497 — TEMP TELLER-INFRARED TYMPANIC THERMOMETER, MODELS TT-200, TT-201
- K990739 — QUANTEC-E ENDO SYSTEM
- K990963 — RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE)
- K991415 — SUPERGLOVES, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
- K991431 — 14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT
- K991493 — BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
- K991673 — CORDIS TEMPO ANGIOGRAPHY CATHETER
- K990239 — COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
- K990763 — VITRON M
- K990978 — ALBUMIN BCG, MODEL AL 103-01
- K990980 — BUN, MODEL BU 104-01
- K990981 — GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE (R2), MODEL GL101-02
- K991108 — CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01
- K991109 — CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02
- K991111 — BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02
- K991244 — TOTAL IRON, MODELS FE 109-01, FE 109-02
- K991247 — URIC ACID, MODEL UA112-01
- K991386 — EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK)
- K991466 — EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE)
- K981549 — LACTATION TECHNIQUES MODEL B
- K983862 — CLOUD 1 HUMIDIFICATION SYSTEM
- K990045 — BERACLAMP, MODEL BC-1
- K990574 — STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964
- K990593 — PELVX INCONTINENCE DISH, MODEL 301-306
- K991231 — HITACHI VERSIFLEX
- K984261 — SURESTEP BLOOD GLUCOSE MONITORING SYSTEM
- K984328 — LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001
- K984395 — SURGEON'S GLOVES
- K990346 — BAYER ADVIA 1650 CHEMISTRY SYSTEM
- K990572 — SONOTOME
- K990878 — BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE)
- K990882 — LAGLOVE BRAND COLORED NITRILE EXAMINATION GLOVES (POWDER FREE)
- K991039 — EASYSAFE RETRACTING NEEDLE SYRINGE
- K991270 — SMARTEMP
- K991317 — POWDER-FREE LATEX SURGEON'S GLOVE SAFESKIN PFS PLUS CONTAINS 50MLGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
- K991428 — ASCENT KNEE SYSTEM
- K991644 — MICROGAS 7650 TRANSCUTANEOUS MONITOR
- K991732 — CENTRAFIX EXTERNAL FIXATOR
- K973078 — WRIST BLOOD PRESSURE METER MODEL SE-330
- K973592 — WALKCARE P200 SYSTEM
- K983840 — WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)
- K984270 — VAPO-SOLUTION FOR USE IN MDT HARVEY CHEMICLAVE STERILIZERS, MODELS 5000, 5500, AND 6000
- K990193 — IODINE BRACHYTHERAPY SEEDS, MODEL 3000
- K990560 — LIFE IMAGING SYSTEMS, MODEL L3DI
- K990690 — POLYMER COATED POWDERFREE LATEX EXAMINTATION GLOVES
- K990710 — BARRIERPLUS SYNTHETIC POWDER-FREE SURGICAL GLOVES
- K990839 — TRU-CORE I REUSABLE BIOPSY INSTRUMENT
- K991057 — EXTRA LARGE BODY COIL FOR OPART (MRT-600)
- K991220 — VITRON H
- K991221 — VESTOGUM
- K991435 — AII-PRO 100 PLUS AND ALL-PRO 200
- K983831 — VECTORVISION2
- K984285 — OSTEOGRAM BONE DENSITOMETER
- K984407 — BIPAP HARMONY S/T, MODEL 1001445
- K990016 — VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLS
- K990522 — WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS
- K990538 — BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE
- K990635 — VISTA STEREOSCOPE SYSTEM
- K990645 — GALLINI ATRA-CUT NEEDLE
- K990731 — EASTGATE PERSONAL MONITOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.