FDA 510(k) clearances — page 845
clearances on record, most recent first.
Clearances — page 845
84,401–84,500 of 175,890- K983860 — MTM BIOSCANNER K TEST STRIPS, CAT # BSA610
- K990959 — K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM
- K992482 — DELIGHT II HAIR REMOVAL SYSTEM (THE DELIGHT SYSTEM)
- K992949 — SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST
- K993142 — ELITE CUSTOM
- K993143 — VITALITY SYSTEM
- K993485 — VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE
- K993771 — CARESIDE DIRECT BILIRUBIN
- K993851 — SODEM PERFORATOR DRIVE
- K993853 — K-ASSAY MULTI-ANALYTE CALIBRATOR
- K993936 — 15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE, 5MM SITESELECT BREAST BIOPSY DEVICE
- K993993 — HARDYDISK AMIKACIN 30MCG
- K994075 — GEIGER DISPOSABLE ELECTROSURGICAL ELECTRODE, MODEL 435
- K994149 — MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO.
- K994166 — GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE
- K990079 — FASTSEAL CHEST WOUND DRESSING
- K990416 — OMNICORDER BIOSCAN SYSTEM
- K992008 — PHARMASEED, MODEL BT-125-1
- K992074 — MPM REGENECARE WOUND GEL
- K993209 — SOFTLIGHT Q-SWITCHED ND: YAG LASER WITH OPTIONAL BEAM-SHRINKING HANDPIECE ACCESSORY
- K993342 — DUCPREP BREAST ASPIRATOR, MODEL PMPO2
- K993424 — THE TRUE Y CLIP, THE MICRO Y CLIP, THE LAPAROSCOPIC Y CLIP
- K993651 — O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER
- K993731 — SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM
- K994068 — S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
- K991139 — GUGLIELMI DETACHABLE (GDC)
- K992092 — STAT-SHELL DISPOSABLE SPO2 SENSOR
- K992211 — SPO2 WRAP SENSOR
- K992390 — HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD
- K992402 — 5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH
- K992587 — EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM
- K993486 — PARAGON LENS CARRIER
- K993487 — PARAGON LENS VIAL
- K993544 — SPACE-OR RETRACTOR
- K993717 — ENIGMA HI-BASE DENTURE BASE MATERIAL
- K993932 — SOLITAIRE 2
- K994038 — MODULAR REACH HIP
- K994039 — ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR I.V. INFUSION PUMP-6 THERAPY CONFIGURATION, AB
- K994145 — VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS
- K980760 — KLS-MARTIN MMF SCREW
- K981784 — IGM MININEPH ANTISERUM
- K990173 — PATHFINDER II ANGIOGRAPHIC CATHETER
- K990258 — QUANTECH TOTAL B-HCG ASSAY
- K990899 — HEMOCHEK-A1C SAMPLE COLLECTION KIT
- K991074 — BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST
- K991697 — UNI-GOLD H. PYLORI
- K992232 — FIRST RESPONSE 1-STEP PREGNANCY
- K992456 — GRADILEIDEN V TEST
- K992502 — AXIS %CDT TURBIDIMETRIC IMMUNOASSAY
- K992954 — KEELER CRYO MASTER & PROBES
- K993107 — BIO-RAD HOMOCYSTEINE BY HPLC
- K993227 — PHILIPS INTURIS DICOM RECORDER
- K993359 — RAPTOR TREATMENT PLANNING SYSTEM
- K993381 — TONGUE STABILIZER DEVICE
- K993590 — FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET
- K993612 — BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA
- K993645 — CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM
- K993655 — MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS
- K993673 — SNN FLUORO NAVIGATION SYSTEM
- K993681 — DIGITEC TWO STAGE COMPRESSION KIT
- K993687 — UROVIEW 2800
- K993710 — MODIFICATION OF PARAPOST CEMENT
- K993716 — PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE
- K993727 — BINDAZYME ANTI-DSDNA EIA KIT
- K993755 — EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5
- K993796 — RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA, OPIATES, AMPHETAMINE AND METHAMPHETAMINE
- K993812 — CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL R96 K, VIRAL TRANSPORT KIT, MODEL R99 K
- K993868 — THE SOUNDVASER DISSECTION SYSTEM
- K993883 — M-PACT CORNEAL LIGHT SHIELD
- K993935 — DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPI
- K993947 — KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAMILY
- K993962 — PENSIL TRAUMA, MODEL WWS6100
- K993994 — HARDYDISK AZITHROMYCIN 15MCG
- K994009 — CG-2100 ECG TRANSMITTER
- K994045 — PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2
- K994101 — E. HISTOLYTICA II
- K994110 — LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
- K994175 — MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE
- K994187 — SYNTHES CERVIFIX SYSTEM
- K981783 — C3 MININEPH ANTISERUM
- K981785 — C4 MININEPH ANTISERUM
- K981915 — TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION
- K982100 — IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS
- K990849 — DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS)
- K991439 — POLLER CALIBRANTS
- K991835 — HANG UPS POWER II
- K991964 — EIS THREADED SCREW FRACTURE FIXATION
- K992121 — EMBOLIZATION COIL SYSTEM
- K992355 — LACTOSORB TRAUMA PLATING SYSTEM
- K992531 — ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM
- K992635 — INTERFACE MODULE IDDD
- K993048 — ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST
- K993096 — PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITOR
- K993169 — MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A
- K993289 — SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEM
- K993371 — SADDLE SHAPED PATELLA
- K993375 — CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER
- K993386 — LATEX EXAMINATION POWDERED GLOVES
- K993402 — OPUS SPINAL SYSTEM
- K993432 — ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z46
Data sourced from openFDA. This site is unofficial and independent of the FDA.