FDA 510(k) clearances — page 820
clearances on record, most recent first.
Clearances — page 820
81,901–82,000 of 176,637- K002391 — NITRILE PATIENT EXAMINATION GLOVE, POWDERED, NON-STERILE, (MULTIPLE COLORS)
- K002749 — ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D
- K002753 — SPARTAN A-10
- K002755 — NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE
- K002761 — FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS
- K002853 — SCITON IMAGE HAIR REMOVAL LASER
- K002884 — PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES
- K002893 — FLUOROLAB PLUS
- K002941 — ACETABULAR PLATES
- K002987 — REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE
- K003029 — INFUSOMAT P
- K003245 — HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML
- K003374 — FERMIT PLUS
- K003377 — FERMIT N PLUS
- K003587 — CLEARGLIDE PRECISION BIPOLAR DEVICE
- K994078 — U1 HIP SYSTEM
- K002807 — 3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING
- K003110 — MEDCOMP BIO-CATH CATHETER LINE
- K003266 — SIREMOBIL ISO-C 3D
- K003276 — TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107
- K003398 — WIRECLIP TORQUER
- K003421 — DEPUY C-STEM SYSTEM
- K003445 — FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2
- K003534 — PENTRA 5D
- K000806 — KARL STORZ HYSTEROMAT II
- K001510 — OS-2000 OPTICAL SONOGRAPHY SYSTEM
- K002493 — DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION) NEWBORN/INFANT ARTERIAL FILTER
- K002740 — TIBIAL & PATELLAR COMPONENTS FOR THE PROFIX & GENESIS II TOTAL KNEE SYSTEMS
- K002766 — NICOLET VASOGUARD
- K003034 — COLTENE AURA COMPOMER RESTORATIVE SYSTEM
- K003096 — FASTPACK CALIBRATORS
- K003239 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506
- K003242 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623
- K003379 — V-40/C-TAPER ADAPTER SLEEVE
- K003429 — MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL
- K003497 — DISPOSABLE PRESSURE MONITOR
- K000004 — ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509
- K001278 — SENSAIRE DIAGNOSTIC SPIROMETER
- K001525 — CAPTIA SYPHILIS-G ELISA TEST SYSTEM
- K002010 — STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421
- K002472 — DELTA 32 AND DELTA 32 TACT
- K002593 — POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
- K002721 — AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH
- K002781 — MEDICAL CABLES PATIENT MONITORING CABLES FOR ECG, EEG, SPO2, AND BLOOD PRESSURE MONITORS
- K002787 — MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120
- K002818 — NIRTRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDERED, NON STERILE
- K002819 — NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR) POWDERED, NON STERILE
- K002834 — SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSOR
- K002861 — EO GAS STERILIZATION PROCESS INDICATOR TAPES, MODEL CI 124
- K002938 — B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16
- K002986 — A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5
- K003030 — LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET
- K003095 — FASTPACK CONTROL
- K003213 — ALMATEX POWDER-FREE LATEX EXANINATION GLOVES WITH PROTIEN LABELING CLAIM 50 MICROGRAMS OR LESS
- K993852 — FIRST CHECK HOME DRUG TEST PANEL 4
- K002064 — COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL
- K002262 — DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM
- K002288 — ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER
- K002708 — KAVO CORUND HANDPIECE 2013
- K002714 — WARTNER WART REMOVAL SYSTEM
- K002916 — SURGI-VISION PROSTATE COIL
- K002991 — ZAP DUAL CURING LIGHT
- K003011 — SELF ETCH BONDING PRIMER
- K003361 — RENEW LS-2
- K003373 — PROCAD ADD-ON
- K003391 — OSTEONICS ALUMINA C-TAPER HEAD
- K003473 — DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM
- K001521 — SOFTSENS
- K002263 — BRANAN MEDICAL CORPORARTION MONITECT THC DRUG SCREEN TEST
- K002264 — BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST
- K002265 — BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE DRUG SCREEN TEST
- K002268 — BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEN TEST
- K002342 — BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST
- K002852 — N/T PROTEIN CONTROL SL
- K003069 — ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM
- K003093 — ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30
- K003359 — COLOSCREEN-ES
- K003414 — VARELISA TG (THYROGLOBULIN) ANTIBODIES,
- K003488 — SYNCHRON CONTROL
- K000651 — DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM
- K001564 — SCAN LT40 (40 CHANNELS)
- K001692 — NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8
- K002098 — SALUMEDICA NERVE CUFF
- K002184 — COD COMPRESSION OSTEOTOMY DEVICE
- K002757 — ONCOLOGY SALVAGE SYSTEM
- K002764 — HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR
- K002765 — LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE
- K002886 — IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)
- K002931 — METRX SYSTEM
- K003028 — CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC
- K003046 — IMAGE VASCULAR LASER
- K003384 — VERSALINK TITANIUM ROD-TO-ROD COUPLERS
- K003413 — ALUMINA V40 HEAD
- K003428 — ISS OFFSET HEADS
- K000404 — PC ECG 1200
- K001520 — ALPHA OMEGA DUAL COOLER-HEATER
- K001563 — SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET
- K001600 — <GENX> CODA INCUBATOR CELLMATE
- K001613 — COMFIT CHEMO PLUS PLUS POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
- K001651 — BIO-RAD %CDT TIA
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