FDA 510(k) clearances — page 867
clearances on record, most recent first.
Clearances — page 867
86,601–86,700 of 175,890- 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
- K990894 — ETB TROCAR SYSTEM
- K991010 — ACP
- K991120 — VACUTAINER BRAND CTAD TUBE (MULTIPLE)
- K991182 — MODIFICATION OF N/T PROTEIN CONTROL SL
- K991364 — MODIFICATION TO TENOR SPINAL SYSTEM-PLATES
- K991387 — ELAN ALKALINE PHOSPHATE REAGENT KIT
- K991429 — DIAMOND II VALVE
- K991460 — MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
- K991583 — NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR
- K982925 — LAMINOSS DENTAL IMPLANT
- K984022 — PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT
- K990493 — INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE
- K990509 — OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818
- K990672 — LACRIMAL INTUBATION SET, DACRYOCYSTORHINOSTOMY (DCR) SET
- K990936 — THE VAULT
- K990955 — MODIFICATION OF:BIODERM FOAM WOUND DRESSING
- K990964 — SIGNADRESS DUODERM DRESSING
- K991324 — TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE)
- K991394 — STAPES PROSTHESES
- K991589 — FLEXIBLE VASCULAR CLAMP, VERSION 2
- K983216 — CVS PERSONAL LUBRICANT
- K983665 — MANOMETRIC ASSEMBLIES
- K983720 — ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO-
- K984052 — SYNERGY IOM SYSTEM
- K984229 — LATEX EXAMINATION GLOVES (POWDERED)
- K990381 — TOTALBOND
- K990474 — ORATEC INTERVENTIONS ORA-50 S PROGRAMMABLE ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES
- K990585 — INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER
- K990586 — CONMED ABC PROBE FOR FLEXIBLE ENDOSCOPES
- K990652 — INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER
- K990665 — BQ/BM INTEGRATED LASER DELIVERY SYSTEM
- K990669 — MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9)
- K990699 — ORTHO-GLOW GLITTER
- K990716 — GALLINI BYCUT NEEDLE
- K990840 — NUGARD NITRIL POWDERFREE NITRILE EXAMINATION GLOVE
- K990841 — NUGARD NITRIL NITRILE EXAMINATION GLOVE
- K990848 — TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATION
- K990879 — PRE POWDERED LATEX EXAMINATION GLOVES
- K990935 — JACKSON ESOPHAGEAL DILATOR
- K991030 — PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
- K991172 — IONOSIT BOND
- K991461 — OSTEONICS SCORPIO TOTAL KNEE RELAXED BACK P/S TIBIAL BEARING INSERT
- K991627 — WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600
- K983715 — THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
- K983875 — VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II REAGENT PACK
- K984537 — KERATOME SYSTEM, MODEL K3000
- K990561 — OPTICAL FORCEPS
Data sourced from openFDA. This site is unofficial and independent of the FDA.