FDA 510(k) clearances — page 851
clearances on record, most recent first.
Clearances — page 851
85,001–85,100 of 175,890- K993000 — BARD HYDROPHILIC COATED GUIDE WIRES
- K993147 — DECAP
- K993517 — COMBISON 530D/VOLUSON 530D, TISSUE HARMONIC IMAGING (THI) OPTION
- K984203 — SIUI APOGEE 800PLUS ULTRASOUND IMAGING SYSTEM
- K984433 — QUANTECH CK-MB ASSAY
- K990677 — ABSOGEL CHEMOTHERAPHY GLOVES
- K990826 — INTERACTIVE MR LOCALIZER/ MAGNETOM OPEN AND OPEN VIVA SYSTEM
- K991483 — ABBOTT ARCHITECT GLYCATED HEMOGLOBIN
- K992323 — DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES
- K992512 — ALTIVA CORPORATION NTR 3.3 MM SELF-TAPPING SCREW IMPLANTS, ALTIVA CORPORATION CORPORATION NTR-3.3 MM SELF-TAPPING HA COA
- K992599 — DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR
- K992704 — IL TEST VON WILLEBRAND FACTOR
- K992976 — K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR
- K993034 — MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD
- K993223 — RAPICURE 200 (CURING AND WHITENING LIGHT)
- K993387 — IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K
- K993477 — HRW WRIST ARRAY COIL
- K990738 — DR. JAHANGER'S CUTTER
- K991918 — NUTRISAFE EXTENSION TUBE
- K992560 — MAPS 10000
- K992574 — OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500A
- K992583 — MASS (MICRO-ACCESS SPINE SYSTEM)
- K992586 — KONICA LASER IMAGER, DRYPRO MODEL 722
- K992618 — RESPALERT
- K992649 — ATD AUTOMATIC BRIDGE REMOVER
- K992841 — TG MEDICAL POWDERED NITRILE BLUE EXAMINATION GLOVES
- K992953 — SURGEONS GLOVE, BROWN LATEX POLYMER COATED, POWDER FREE WITH PROTEIN LABEL CLAIM
- K993091 — PALMAZ XL TANSHEPATIC BILIARY STENTS
- K993093 — HEALTH-PLUS, SANITEX, RELIANCE (50 MICROGRAMS)
- K993287 — POWDER FREE (SILICON COATED) LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
- K993490 — QUICKSTRIP ONE STEP OPIATES TEST
- K993491 — QUICKPAC II ONE STEP OPIATES TEST
- K990410 — SERAQUEST EB VCA IGG
- K991601 — DUAL LUMEN CATHETER, MODEL DL-35-90
- K991879 — SPRING-WOUND EPIDURAL CATHETER
- K992169 — ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE
- K993245 — CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM
- K993266 — PROWLER PLUS INFUSION CATHETER
- K993354 — K-ASSAY APO B
- K983000 — CRICOTHYROTOMY TUBE
- K983613 — PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES
- K984465 — OXYCONALPHA WITH OPTION ECG
- K990233 — ST-302 INFRAREX
- K991281 — ELECTRIC MOBILITY CAVALIER SCOOTERS
- K992070 — COOK ULTRA QUIET VACUUM PUMP & REGULATOR
- K992156 — SYNSATION STERILE POWDER FREE, POLYVINYL CHLORIDE MEDICAL EXAMINATION GLOVES
- K992266 — IV ADMINISTRATION SET
- K992421 — GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076
- K992542 — TUBULAR ELECTRODE DEVICE
- K992551 — ALPHA INFUSION PUMP
- K992601 — TEMP TELLER - DIGITAL THERMOMETER, MODELS DT-101, DT-102, DT-103, DT-201, DT-202, DT-203
- K992616 — SDB CERCLAGE SYSTEM
- K992617 — HEX BUTTON
- K992643 — MODEL IRC 1001 AEROSOL COMPRESSOR
- K992653 — SHELLY PROTECTED AV FISTULA NEEDLE
- K992667 — ZMR HIP SYSTEM-REVISION TAPER
- K992784 — NEXT GENERATION RODDING SYSTEM
- K992830 — SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER NITRILE GLOVE
- K993045 — BARIATRIC LAPAROSCOPE, MODEL 367
- K993097 — HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATINO GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAM
- K993192 — ILLUSION
- K993231 — SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES
- K993240 — SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES
- K993258 — SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES
- K993269 — IQ NASAL MASK, MODEL P/N 50160
- K993307 — ARIA LX CPAP SYSTEM
- K993373 — ROTORBLADE SUTURE ANCHOR
- K993433 — VIRTUOSO LX SMART CPAP SYSTEM
- K982521 — SKINTACT ECG ELECTRODES, S&W ECG ELECTRODES
- K992097 — ENDOREZ
- K992522 — SPECTRUM DESIGNS SPECTRAGEL
- K992544 — TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM
- K992926 — GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195)
- K993173 — GOLD CORE 55
- K993175 — GOLD CORE 75
- K990023 — HYBRID CAPTURE II CT-ID TEST
- K990397 — FLEXIBLE FIBERSCOPES & ACCESSORIES
- K991140 — ORATEC INTERVENTIONS VULCAN EAS ELECTROTHERMAL ARTHROSCOPY SYSTEM AND ACCESSORIES
- K991385 — DADE BEHRING N HIGH SENSITIVITY CRP ASSAY
- K991456 — MICROWAVE DELIVERY SYSTEM, MODEL MMC-300
- K991543 — INTRAOP CATHETER
- K991696 — STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM
- K991853 — INTERACOUSTICS EP 15 ABR STAND ALONE UNIT
- K991970 — SCAREASE SHEETS & SCAREASE GEL
- K992269 — VENTIL-A ORAL PROTECTOR
- K992603 — XRT 600 R/F, WRF 0600
- K992619 — AMIGO MODEL 680000 (AMIGO EXCITE F 350)
- K992627 — FIRST CLASS POWER RECLINE SEATING SYSTEM, MODEL S500
- K992628 — FIRSTCLASS POWER TILT AND RECLINE SEAT SYSTEM, MODEL S400
- K992698 — STENTOR, PAGEVIEW
- K992760 — SELECT-SUTTER MICRO BIPOLAR FORCEPS
- K992796 — ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000
- K992837 — 3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATED LC-ABP)
- K992858 — ABBOTT AXSYM HOMOCYSTEINE
- K992902 — AMBU HAND POWER SUCTION PUMP
- K993009 — HYDROCISION ARTHROJET SYSTEM WITH CAUTERY
- K993211 — PICCOLO SODIUM TEST SYSTEM
- K993294 — DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM
- K993341 — INTELLISYSTEM II COLOR MONITOR
- K993345 — K-ASSAY APO AI
Data sourced from openFDA. This site is unofficial and independent of the FDA.