FDA 510(k) clearances — page 890
clearances on record, most recent first.
Clearances — page 890
88,901–89,000 of 175,890- K982690 — BARCO MEDICAL DISPLAY CONFORMITY AND CONSISTENCY SOFTWARE
- K983109 — MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANY
- K983321 — MICROFUSE DUAL RATE INFUSER
- K971549 — VMT SYSTEM
- K981445 — ULTIMA AIRFLOW SENSOR, 0510
- K982064 — ACTION STORM RANGER II, ACTION STORM POWER 9000
- K982099 — MOMENTUM NO. FS008 WHEELCHAIR
- K982489 — RFG-3C PLUS
- K982490 — TENOR SPINAL SYSTEM
- K982550 — BROWSER (EVENT SOFTWARE) MODEL # 4500E
- K982583 — SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TXL
- K982585 — DEPUY AMK TOTAL KNEE SYSTEM DEPUY COORDINATE ULTRA KNEE REVISION SYSTEM
- K982734 — OLYMPUS MH-246R BALLOON SHEATH, FOR URINARY TRACT USE
- K982783 — VAIL 1000 ENCLOSED BED
- K982849 — PANTHER WHEELCHAIR
- K982886 — OTI MODULAR SHOULDER SYSTEM
- K982905 — MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE
- K982918 — DEPUY C-STEM SYSTEM
- K982989 — QUICKIE SUSPENSION WHEELCHAIR SERIES MODEL XTR
- K983121 — NON-STERILE KIRSCHNER WIRES AND STEINMANN PINS, MODELS #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220
- K980484 — AESCULAP SPINE SYSTEM EVOLUTION
- K982358 — HISTOFREEZER DEVICE
- K982359 — NC-STAT
- K982375 — STRYKER HIP ARTHOROSCOPY SET
- K982538 — BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP
- K982598 — OTI FEMORAL LOCK TOTAL HIP SYSTEM
- K982670 — CONTEMPORARY ACETABULAR COMPONENT
- K982907 — MAGNATEK 40
- K982914 — AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTS
- K983027 — TRIMETHOPRIM/SULPHAMETHOXAZOLE
- K980812 — IMX HOMOCYSTEINE
- K981295 — UPRO
- K981345 — CHOLESTRON PRO II CHOLESTEROL TEST
- K981630 — VYGON DOUBLE LUMEN UMBILICAL CATHETER
- K981861 — LINER 1:HARD RELINE LIQUID
- K982848 — COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT
- K983023 — MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
- K972140 — A1 ACOUSTIC RHINOMETER
- K972675 — CO2 GAS WARMING UNIT (6-800-00)
- K972866 — HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT
- K973203 — THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES
- K973447 — OMNIFLATOR 6630(6-630-00)
- K974170 — DUOSTAR
- K980839 — AVOCET PT
- K981337 — DIGITAL CLINICAL THERMOMETER, MODELS ST-833A & ST-834A
- K981711 — SYSMEX AUTOMATED COAGULATION ANALYZER CA-500
- K981876 — SYNTHETIC EXAMINATION GLOVE, POWDERED
- K982020 — METRON QA-IDS I.V. PUMP TESTER
- K982113 — UMECO OPTIMA 694 RUBY LASER SYSTEM
- K982256 — OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP
- K982349 — SOMATOM PLUS 4WITH VOLUME ZOOM CT SCANNERS
- K982422 — EAGLESOFT CHAIRSIDE
- K982440 — NITRILE PATIENT EXAMINATION GLOVE
- K982459 — TEMPFIL F - 2
- K982463 — EXTRACRANIAL RADIOTHERAPY SYSTEM
- K982482 — HANDMASTER NMS1
- K982509 — ORTHO IMPLANT AND ACCESSORIES
- K982620 — MEDIVISION CYSTOSCOPE
- K982623 — AESCULAP NEEDLESCOPIC INSTRUMENT SYSTEM
- K982648 — JOAN II
- K982704 — DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE
- K982752 — SEARE BIOMEDICAL CHIN IMPLANTS
- K982753 — SEARE BIOMEDICAL NASAL IMPLANTS
- K982762 — SEARE BIOMEDICAL PECTORALIS IMPLANT
- K982763 — SEARE BIOMEDICAL MALAR IMPLANTS
- K982779 — MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOMER CEMENT TYPE 1
- K982781 — DEMOLIZER #47 ONE-GALLON POINT OF GENERATION SHARPS CONTAINER
- K982806 — CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE
- K982807 — POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE
- K982822 — FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72
- K982868 — ETEST RIFAMPICIN WITH INDICATIONS FOR S. PNEUMONIAE
- K982891 — CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS
- K983041 — SEARE BIOMEDICAL SILICONE SHEETING
- K983043 — SEARE BIOMEDICAL SILICONE BLOCK
- K983161 — KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC
- K974813 — COMBISON 530D WITH POWER DOPPLER MODE
- K974901 — HYBRID CAPTURE SYSTEM CMV DNA ASSAY
- K981055 — XKNIFE-4
- K981306 — DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM
- K981553 — AUTOMATED MEDICAL REPORT WRITER
- K981834 — PERCEPTION INC, GPS-6TBMD DIAGNOSTIC ULTRASOUND SYSTEM
- K982446 — DYNAMIC SHIELDING RADIATION TABLE
- K982983 — LSVP INTERNATIONAL BIOPSY FORCEPS
- K982993 — PHILIPS OMNIDIAGNOST
- K983130 — LIQUID IMMUNOLOGY CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS
- K983241 — ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS
- K980997 — PGK DEVICE (MODIFIED)
- K981226 — IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3
- K981394 — BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720
- K981817 — COAMATIC PLASMIN INHIBITOR
- K981867 — IS-VZU IGG TEST SYSTEM
- K982382 — COBAS INTEGRA REAGENT CASSETTES
- K983131 — AST
- K983147 — ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P
- K971924 — BLUNT SYRINGE CANNULA
- K973637 — PRESS-MATE ADVANTAGE
- K980817 — PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L
- K981299 — SILVERLON CONTACT WOUND DRESSING
- K981940 — MULTAPUMP DISPOSABLE PUMP HEAD AND ACCESSORIES
- K982266 — HYDROCISION ARTHROJET SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.