FDA 510(k) clearances — page 870
clearances on record, most recent first.
Clearances — page 870
86,901–87,000 of 175,890- K990915 — INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY
- K990916 — INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY
- K990948 — S575 INTRAORAL DOCKING DENTAL CAMERA
- K981995 — QUICKDRAW VENOUS CANNULA
- K982053 — EEG ELECTRODES MODEL 445 SERIES
- K983338 — FREIBURG FLAP APPLICATOR SET, PART NUMBER 089.095
- K984589 — PHOTOTHERAPY LAMP
- K990387 — ENDOMETRIAL SAMPLER
- K990754 — CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50
- K990939 — FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
- K991130 — FLEXPLUG
- K980903 — RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COAT
- K990159 — DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111
- K990189 — MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER
- K990199 — SMARTRECORDER, MODEL 2500
- K990434 — CARESIDE CKMB
- K990439 — CARESIDE CK
- K990972 — HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE T
- K983830 — COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER
- K983948 — BEACON, MODEL 211060
- K984446 — `BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH
- K990031 — NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES
- K990147 — BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771
- K990248 — DICOM IMAGE MANAGER, MODEL 3-D VISUALIZATION OPTION
- K990281 — S-38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, THE ESSTECH PS & SV (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
- K990406 — KINGLI ACUPUNCTURE NEEDLE
- K990458 — STRAUMANN EXTRAORAL IMPLANT SYSTEM
- K990715 — SHIMADZU CEILING TUBE SUPPORT CH-30GH
- K990824 — REVISED C-REACTIVE PROTEIN CALIBRATOR
- K990825 — REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE
- K990928 — LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405
- K991034 — CONVERTORS SURGICAL GOWNS
- K974236 — MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 20CM SB
- K982132 — BLEASE 6200 ANAESTHESIA VENTILATOR
- K983341 — STANDARD CT/MR APPLICATOR SET,RING CT/MR APPLICATOR SET, VAGINAL CT/MR APPLICATOR SET, FLETCHER WILLIAMSON APPLICATOR SE
- K984222 — QUANTA LITE LYME IGG ELISA
- K984234 — QUANTA LITE LYME IGM ELISA
- K984504 — NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES
- K990010 — ALTHIN MEDICAL AB ALTRACART II
- K990260 — OPART
- K990399 — ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8
- K990409 — ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K)
- K990759 — VIEW COM
- K990919 — STRAIGHT ASPIRATOR, 90 DEGREE ASPIRATOR,45 DEGREE ASPIRATOR,7 FRENCH ASPIRATOR,EXTENDED STRAIGHT ASPIRATOR,13.9 CM STRAG
- K991018 — ACCUSIGN BAR, BIOSIGN BAR, STATUS BAR
- K991076 — ACCUSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP
- K991078 — ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8
- K991079 — ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO
- K991080 — ACCUSIGN MTD, BIOSIGN MTD
- K991082 — ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA RAPIDTEST D.A.U. 2 BAR/BZO
- K991084 — ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/MTD
- K982134 — DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851
- K982144 — MEGA 4
- K982145 — MEGA 3
- K984213 — NEARLY ME RETOUCH SILICONE SCAR REDUCTION SHEETS
- K990332 — DUMEX IODOFORM PACKING STRIP
- K990361 — HEADED BIO-ABSORBABLE CORKSCREW MODEL #AR-1921BU
- K990414 — SMITH & NEPHEW HANDPORT SYSTEM
- K990417 — DERMACOOL
- K990594 — INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1
- K990595 — INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B
- K990895 — OXYCON LENS
- K990999 — MODIFICATION OF: EBI SPINELINK SYSTEM
- K991150 — NELLCOR PURITAN BENNETT, GOODKNIGHT 418G
- K983461 — UNI-FLEX RESIN
- K983892 — COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P
- K990170 — HOLTER 2000
- K990172 — TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA
- K990231 — WILTEK HOT BIOPSY FORCEPS
- K990395 — BARRIER SURGICAL GOWNS
- K990418 — ONTRAK TESTCUP-ER M2K
- K990449 — HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE
- K990711 — CODAN CHEMOSPIKE
- K990845 — MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15
- K990983 — MODIFICATION TO IMTEC SENDAX MDI
- K982722 — AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD
- K983102 — CARDIAC DIAGNOSTIC SYSTEM MODEL CH 2000
- K984056 — LTV 1000
- K990123 — PVR-100/VASOGRAM
- K990129 — TL250 INTERFERENTIAL/MUSCLE STIMULATOR INTERFERENTIAL CURRENT THERAPY MUSCLE STIMULATOR
- K990224 — LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET
- K990370 — MSB (ELECTRICAL STIMULATION) ELECTRODES (DISPOSABLE). (TENS/FES/NMES)
- K990813 — REHCOR
- K990861 — WOUND DRESSING/ABD PAD, MODEL #10810
- K982137 — BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE
- K982617 — TRACER
- K984059 — ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER
- K984337 — ELASTYLON POWDER-FREE SURGICAL GLOVE
- K984389 — TOP WHOLESOME FACE MASK
- K990082 — EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09
- K990277 — O-RING ABUTMENT
- K990363 — BIOMESH BIODEGRADABLE GTR BARRIER
- K990539 — BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE)
- K990540 — BRIGHTWAY BRAND LATEX EXAMINATION GLOVE (LOW PROTEIN)
- K990541 — BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE)
- K990542 — BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)
- K990543 — BRIGHTWAY BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE)
- K990827 — MICROPLATE NEONATAL GALT ASSAY
- K982365 — ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMAT
- K982940 — LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.