FDA 510(k) clearances — page 852
clearances on record, most recent first.
Clearances — page 852
85,101–85,200 of 176,637- K993585 — VARELISA TPO ANTIBODIES, MODEL 12348/12396
- K993949 — SOLO-CARE BRAND HARD SOLUTION
- K994253 — VACLOK SYRINGE
- K991647 — TFX MEDICAL INTRODUCER KIT
- K993361 — TUBING EXTENSION SET
- K993463 — INTRAVASCULAR ADMINISTRATION SET
- K993672 — REBAR MICRO CATHETER, MODELS 105-5080, 105-5086
- K994252 — INTRODUCER SHEATHS, VESSEL DILATOR, GUIDEWIRE
- K993461 — QUEST INTERSEGMENTAL ROLLER TRACTION TABLE
- K993556 — LIQUIBAND DENTAL
- K993850 — URINALYSIS REAGENT STRIPS (10 PARAMETERS)
- K993873 — ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD
- K993919 — DYNATRON 900
- K994111 — CELSITE, MODELS ST401L, ST405L
- K994251 — KETAC-MOLAR QUICK
- K993232 — WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
- K993330 — THERMOCHEM-HT SYSTEM
- K993969 — SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION
- K994186 — DISETRONIC D-TRON INSULIN INFUSION PUMP
- K994219 — AT HOME DRUG TEST, MODEL 9073
- K994220 — AT HOME DRUG TEST, MODEL 9078
- K994233 — AT HOME DRUG TEST, MODEL 9068
- K994234 — AT HOME DRUG TEST, MODEL 9083
- K994236 — AT HOME DRUG TEST, MODEL 9133
- K994237 — AT HOME DRUG TEST, MODEL 9063
- K992148 — HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT
- K992927 — STEALTHSTATION TREATMENT GUIDANCE PLATFORM
- K993030 — MODIFICATION TO ISOLA SPINAL SYSTEM
- K993283 — OSCAR NET/CD, MODEL M1.82 600 . O/A/B/C
- K993288 — SULZER CARBOMEDICS CARDIOFIX PERICARDIUM
- K993338 — INTEGRATED DIGITAL MEDICAL RECORD (IDMR)
- K993450 — LATEX SURGICAL GLOVES, PRE-POWDERED
- K993529 — POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K993542 — ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL V46
- K993562 — POWDER FREE LATEX STERILE SURGICAL GLOVES
- K993575 — RESOLVE QUICKANCHOR
- K993621 — HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MIC
- K993693 — INVIGRA
- K993862 — MODUS SAGITTAL SPLIT PLATE
- K994197 — DISENTRONIC PENFINE INJECTION PEN NEEDLE
- K991441 — CADENCE DOPPLER ULTRASOUND SYSTEM
- K991541 — A-MED VASCULAR CANNULA, MODELS V24-10-08, V24-10-16, V24-10-32, V24-21-08, V24-21-44
- K991562 — PASCAL MEDICAL AB MENIETT 20
- K993591 — BLADEWORKS DISPOSABLE ALK TUBING
- K993643 — NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100
- K993650 — URETERAL ACCESS SHEATH SET - NEW MODELS
- K993761 — CARDIOVASCULAR MEASUREMENT SYSTEM - VIEW
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.