FDA 510(k) clearances — page 1420
clearances on record, most recent first.
Clearances — page 1420
141,901–142,000 of 175,890- K864468 — TRACHEOBRONCHIAL SUCTION CATHETER
- K864503 — MODIFIED RLV-2100 B
- K864535 — TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110
- K864601 — CCS POLYSAFE(TM) ENDOCARDIAL PACING LEAD
- K864637 — MODIFIED ESCHMANN DILATATION CATHETER
- K864640 — ANCOR PERVENOUS ACTIVE FIXATION UNIPOLAR LEAD
- K864682 — SALT CREEK P.I. TRAY
- K864738 — MODEL 366-14 INTERMEDICS LEAD CONNECTOR CAP
- K864823 — BEHIND THE EAR HEARING AIDS, BERNAFON COLIBRI, C1
- K864856 — MODEL 5866-24 PACEMAKER LEAD ADAPTOR
- K864878 — ICU/CPU TRANSPORT TRAY
- K853952 — METRIFLOW AFM-100 PERIPHERAL VASCULAR BLOOD FLOWME
- K861205 — 1990A BIO-RESISTANCE BODY COMPOSITION ANALYZER
- K862867 — EUB-310 ULTRASONIC SCANNER
- K863470 — DALTEX IV INFUSION PUMP
- K864211 — IL TEST 97575-15, HEPARIN ASSAY
- K864224 — ABBOTT SPECTRUM GLUCOSE REAGENT
- K864333 — DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY
- K864392 — PROTIME AUTOMATE TEST KIT
- K864481 — COAGULATION INTRINSIC DEFICIENT PLASMAS
- K864497 — COAGULATION EXTRINSIC DEFICIENT PLASMAS
- K864646 — SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE
- K864669 — AM CATH ESWL STENT
- K864674 — MICRODILUTION IDENTIFICATION PANELS
- K864706 — RAICHEM(TM) AMMONIA REAGENT
- K864727 — CULT-UR
- K864733 — LKB 2260 MACROTOME
- K864740 — BONE MARROW COLLECTION MEDIUM
- K864755 — PSEUDOMONAS CEPACIA SELECTIVE AGAR, DRI & PRE-FORM
- K864817 — S&W MODEL HIGH-LOW MAT TABLE, VARIOUS MODELS
- K864907 — SUNTANNING LAMP
- K864945 — TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY
- K862211 — ULTRASOUND TRANSDUCER ASSEMBLY
- K862459 — MODIFIED CIRCUIT BURN-IN PROCESS IMPLANTABLE PULSE
- K862724 — VEIN VALVE CUTTER
- K863308 — 2200I PHYSIOLOGICAL MONITOR
- K864007 — EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER
- K864235 — BARD(R) WM HARVEY(R) BLOOD OXYGENATOR/MODEL H-1600
- K864262 — ARTERIAL 20/40 MICRON FILTERS W/WO HEPARIN COATING
- K863069 — MAGNESIOMETER
- K863580 — DERMATEC TRANSPARENT FILM DRESSING
- K864236 — SYNCHRON CX3
- K864303 — QKO (TM) AMYLASE B-HA
- K864634 — AP1 COLORIMETER
- K864713 — CHLORIDE REAGENT
- K864715 — EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93
- K864776 — A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS
- K864906 — ALANINE AMINO TRANSFERASE ALT/SGPT
- K864939 — BECKMAN DRI-STAT TRIGLYCERIDES-GPO REAGENT KIT
- K864495 — MEDSURG VASCULAR ACCESS PORT INFUSION TRAY
- K864570 — PAMITEX,LONG LOVE,DESIRE,SKIN LESS,GINZA,LOVE TIME
- K864892 — ELLISON ARTHROSCOPY CHEATER
- K863237 — HYDROXYLAPATITE BONE GRAFT MATERIAL
- K863736 — FMS MODEL 110
- K863780 — ADA-1000 (ADVANCED DIGITAL ARRAY)
- K863970 — MLC ENDOTHELIAL CELL COUNTER
- K864076 — HERCON ANTISEPTIC TRANSPARENT DRESSING
- K864138 — MINIMED MODEL 404-S EXTERNAL INFUSION PUMP
- K864263 — NEOPROBE PORTABLE RADIOISOTOPE DETECTOR
- K864264 — TRICOTEX WOUND CONTACT LAYER DRESSING
- K864284 — MUSCLE MASTER (MEDIUM VOLTAGE STIMULATOR)
- K864292 — DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY
- K864558 — U66 EMS
- K864584 — FLUOROVISION CONTRAST ENHANCER
- K864625 — MYOPAC (TM), MODEL 9600
- K864630 — KC/EMG DIAGNOSTIC ELECTROMYOGRAPH
- K864639 — REUSABLE SURGICAL KERATOSCOPE
- K864653 — MODEL 2060 W/6 CM(2) & MODEL 2100 W/10 CM(2) TRANS
- K864676 — HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM
- K864747 — VARIOUS SYRINGES W/NEEDLES, W/OUT NEEDLES, NEEDLES
- K864764 — CULTURIA MACCONKEY-MUG/CLED SYSTEMS
- K864777 — MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 3ML/CC
- K864778 — MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 30ML/CC
- K864779 — MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CC
- K864781 — MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 20ML/CC
- K864788 — EXACTECH TOTAL HIP INSTRUMENTS
- K864880 — COLLINS POSITIONING DEVICE
- K864881 — ARTHROSCOPIC ANKLE HOLDER
- K863215 — FASCICULATED I ROD
- K863239 — FASCICULATED BOAT ROD
- K863271 — FASCICULATED S ROD
- K864184 — MCGHAN LONGTERM MAMMARY EXPANDER/GEL-SALINE DESIGN
- K864185 — MCGHAN LONGTERM MAMMARY EXPANDER, RTV DESIGN
- K864291 — HIGH FREQUENCY NEEDLE-TYPE EPILATOR
- K864550 — CARETEX SHOE COVERS
- K864736 — AKRO-SIL PLUS
- K864801 — THE KEYMED HI-LIGHT 250 LIGHT SOURCE
- K864804 — CLOWARD DISPOSABLE ARMRESTS AND FACE REST
- K864805 — CLOWARD SURGICAL SADDLE
- K864824 — INFECTIOUS TISSUE KIT
- K864846 — RADIOGRAPHIC - LEG SECTION
- K864901 — 2000LT WHEELCHAIR
- K864918 — HEALTH PRODUCTS, INC. ORTHODERM THERAPY CHAIR
- K864551 — BIOPSY ADAPTER #H4221BG
- K864780 — MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 1ML/CC
- K864782 — MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 10ML/CC
- K864783 — MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 5ML/CC
- K861856 — NBP 488, TPR 488
- K862602 — AXION IV GOLDLINE SERIES
- K862668 — HEALTHPHONE(TM)
Data sourced from openFDA. This site is unofficial and independent of the FDA.