FDA 510(k) clearances — page 941
clearances on record, most recent first.
Clearances — page 941
94,001–94,100 of 175,890- K962312 — KEY CHAIN EMERGENCY AIRWAY
- K963920 — 8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER,
- K964818 — ORION SERIES SURGICAL LASER SYSTEM (Q-SWITCHED ND:YAG CONFIGURATION)
- K965041 — OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) SYSTEM
- K965042 — MICRODL DIARYCARD SPIROMETER
- K970083 — DYNABITE HOT GI BIOPSY FORCEPS
- K970887 — BLOOD FLOW ANALYZER
- K970992 — PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS
- K971024 — SOFTSCAN
- K971031 — AUDALLION III HEARING SYSTEM
- K971032 — DANAVOX MODELS 163/162 BTE
- K971065 — DENTICA PULSED ND: YAG LASER SYSTEMS AND ACCESSORIES
- K971291 — HEARTPORT ENDOARTERIAL RETURN CANNULA
- K971379 — TINAQUANT RHEUMATOID FACTOR ASSAY
- K971428 — COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0
- K971439 — STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES
- K971449 — VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)
- K971908 — CREA OR CREATININE
- K971967 — BUN
- K971976 — DIASCREEN REAGENT STRIPS
- K961634 — NIL - POWDER-FREE LATEX EXAMINATION GLOVES
- K964264 — HIGH RANGE PEROXIDE TEST STRIP
- K964295 — N-ASSAY TIA TRANSFERRIN TEST KIT
- K964368 — ELECSYS CEA ASSAY
- K964724 — POWDER-FREE LATEX EXAMINATION GLOVES
- K965044 — GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102
- K970131 — ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE
- K970150 — MYCOPLASMA IGG ELISA TEST SYSTEM
- K970991 — DATEX ENGSTOM MANUAL RESUSCITATOR
- K971053 — ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS
- K971111 — TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER
- K971162 — LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR
- K971190 — N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
- K971247 — SNT DISPOSABLE BIOPSY NEEDLE
- K971276 — GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER
- K971405 — SPECIALITY URINE 1,2
- K971467 — SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU)
- K971709 — TOTAL THROXINE MICROPLATE EIA(225-300)
- K971779 — TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA
- K971823 — ACTIVE TESTOSTERONE EIA (DSL-10-4000)
- K971902 — ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT
- K971952 — LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600)
- K972004 — ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS
- K925501 — NYLON COATED SPECULA
- K961779 — MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER
- K961787 — BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS
- K962597 — LXN FRUCTOSAMINE TEST SYSTEM
- K963349 — DEVILBISS 8650D
- K963575 — HBF-1000 OMRON BODY COMPOSITION ANALYZER
- K964025 — MITAYA ALUMINUM INTERSPACED X-RAY GRID
- K964507 — ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST
- K964785 — VERIDOSE DIODES
- K970507 — PEAK FLOW METER
- K970590 — N/A
- K970592 — N/A
- K970785 — SIMS HYPERINFLATION BAG SYSTEM
- K970959 — INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT)
- K970964 — MAESTRO DIGITAL IMAGE AND PATIENT RECORD STORAGE SYSTEM
- K970970 — CARDIOMATCH
- K970983 — PERITONEAL/CARDIAC CATHETER
- K971001 — AUTIMO
- K971054 — OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS
- K971074 — THERAPAX SXT 150
- K971087 — SUNGLASSES (FRAME,CELLULOSE PROPINATE, LENS, ACRYLIC)
- K971115 — GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE
- K971158 — DUALINE 400 CIC
- K971186 — AMO DIPLOMAX/OPSYS CONSOLE
- K971230 — SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUS GASTROSTOMY KIT
- K971253 — VARIOUS ARTHROSCOPES, ENDOSCOPIC BLADES, MANUAL INSTRUMENTS
- K971274 — C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM, AT1 AUTOTRANSFUSION SET, PSQ SET
- K971399 — AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC
- K971707 — SUNGLASSES (NON-PRESCRIPTION)
- K971805 — ELECTROSURGICAL TIP CLEANER, TIP CLEANING PAD, LECTROBRASIVE TIP CLEANER, ELECTROSURGICAL TIP CLEANER, ELECTRODE TIP CLE
- K971875 — OPTIM-EYES 450
- K960724 — BIO-GIDE RESORBABLE BILAYER MEMBRANE
- K961711 — ASPISAFE GASTRIC TUBE
- K963612 — DURATION STABILIZED UHMWPE
- K963653 — WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM
- K964842 — IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT
- K965173 — DURATION STABILIZED UHMWPE KNEE COMPONENTS
- K970177 — ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA
- K970934 — CB ERBIUM/2.94(TM) ER:YAG LASER
- K970955 — ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM
- K971061 — OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY
- K971248 — KANEDA SR ANTERIOR SPINAL SYSTEM
- K971334 — PILLING WECK SECONDARY FLEXIBLE SLEEVE WITH TROCAR
- K971444 — 3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES
- K971505 — SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT
- K971674 — VALLEYLAB SINGLE USE SOLID LAPAROSCOPIC ELEC. SPATULA (STRAIGHT & CURVED) J&L HOOK, BALL CONMED SOLID SHAFT ELECTRODE ST
- K971713 — N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
- K971817 — OLYMPUS CK-MB REAGENT
- K971886 — ACCUTEST HCG-URINE
- K971954 — LIQUICHEK URINE CHEMISTRY CONTROL (CAT.NO. 397,398)
- K952172 — HOTMAN
- K963717 — MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS)
- K964679 — WHITE RIVER AUTOMATIC BREAST PUMP
- K970528 — CLYDE CORONARY GUIDEWIRE
- K970917 — SOLOS 10MM OPERATING LAPAROSCOPE
- K970946 — MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SET
- K970954 — O.B. APPLICATOR TAMPONS
Data sourced from openFDA. This site is unofficial and independent of the FDA.