FDA 510(k) clearances — page 554
clearances on record, most recent first.
Clearances — page 554
55,301–55,400 of 175,825- K081276 — ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H
- K081440 — BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES
- K081480 — KEGEL8 PELVIC EXERCISER, MODEL OPH 400
- K081569 — DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS
- K081694 — DENJECTOR
- K081712 — FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700
- K081774 — SOLX 790 TITANIUM SAPPHIRE LASER
- K081778 — NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS
- K081945 — 21.3-INCH (54CM) MONOCHROME LCD MONITOR MS21I2 (MDL2127A)
- K081994 — STARLIGHT
- K082264 — CONTURA LUMEN MARKER
- K082312 — PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM)
- K082324 — TRUFILL DCS SYRINGE
- K082342 — MODIFICATION TO CAPSTONE SPINAL SYSTEM
- K082368 — CARDIUS-1, -2, -3, AND CARDIUS 1,2,3 XPO SPECT IMAGING SYSTEMS, 2020TC SPECT IMAGING SYSTEM
- K082483 — QUANTRA
- K082484 — ACCELAWAVE SYSTEM
- K082494 — DRAD3000E/RADREX-I
- K071455 — ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR
- K073508 — PARKONE
- K080579 — EFFECTIV (TM) CAP
- K080592 — HLM TUBING SET WITH BIOLINE COATING
- K080682 — HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE
- K080696 — ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01
- K080751 — ARCHITECT CYCLOSPORINE
- K081338 — ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP
- K081450 — RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110
- K081523 — EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
- K081693 — NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS
- K081704 — SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS
- K081711 — LUCENT MAGNUM+
- K082073 — ACTIFUSE FLOW BONE GRAFT SUBSTITUTE
- K082087 — EYEFEEL OPHTHALMIC WARMER
- K082307 — EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT
- K082343 — VASCUTRAK 2, MODELS: V14 AND V18
- K082393 — CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
- K082467 — ENSITE FUSION DYNAMIC REGISTRATION TOOL
- K080775 — MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS
- K081557 — PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER
- K081644 — BEAMER ARGON PROBE
- K081656 — VISUALASE THERMAL THERAPY SYSTEM
- K081789 — DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR
- K081898 — EXPEDIUM SPINE SYSTEM
- K082156 — ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 40591213
- K082273 — UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
- K071783 — VERSAPOD (TM) INSTRUMENT TRAYS
- K073328 — CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA
- K073545 — AUDICOR, HEMO AMBULATORY MONITOR
- K080221 — EA STIMULATOR
- K080776 — GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72
- K081374 — CHARLOTTE LISFRANC BONE SCREW, CHARLOTTE LISFRANC PLATE
- K081659 — RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L
- K081744 — PASCAL SYNTHESIS DELIVERY SYSTEM
- K081919 — UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM
- K082146 — METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD
- K082246 — DIGNITY 100
- K082293 — SURGVIEW INTEGRATED VISUALIZATION SYSTEM
- K082485 — MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A
- K082496 — PACSMATE MMD-3213M MONITOR
- K080116 — TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM
- K081013 — MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN
- K081151 — COMPUMEDICS NEUVO
- K081241 — WEIGAO EMPTY CARTRIDGE SYRINGE
- K081547 — BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC
- K081623 — SYNTHES RIB FIXATION SYSTEM
- K082036 — LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK
- K082560 — PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT
- K071803 — ARDS DENTAL IMPLANTS
- K073615 — BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED
- K080196 — Z3D CONTRAST ACUITY
- K080332 — POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330
- K080435 — OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181
- K080531 — CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY
- K080960 — PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS
- K081016 — SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM
- K081225 — CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM
- K081277 — XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)
- K081357 — 5MP GRAYSCALE FLAT PANEL DISPLAY, MODEL, 6GF6201-5C$2# (WHERE $ = A-Z AND # = 0-9)
- K081455 — RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06
- K081518 — ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK
- K081614 — ZEUS SMALL CERVICAL CAGE AND LARGE, EXTRA LARGE, CURVED AND STRAIGHT LUMBAR CAGES
- K081702 — CARBOXYLATE CEM, PHOSPHATE CEM
- K081747 — MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
- K081913 — METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER
- K081961 — 3M UNITEK LAVA CHAIRSIDE ORAL SCANNER
- K082144 — AMICAS PACS, VERSION 6.0
- K082216 — TBD ETHICON MESH
- K082383 — FORTOSS VITAL
- K082426 — RENASYS EZ
- K070250 — NUTRITONE FACIAL BEAUTY SYSTEM
- K070488 — MICARDIA ANNULOPLASTY BAND DR
- K080089 — SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS
- K080412 — ABSORBABLE SYNTHETIC SUTURE WITH NEEDLE ATTACHMENT (PGA BRAIDED)
- K080992 — AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTEM
- K081601 — VEO MULTIGAS MONITOR FOR POCKET PC
- K082206 — BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES
- K082235 — BLACKSTONE PILLAR XL PEEK SPACERS
- K073317 — STARLIGHT, MODEL PD9012
- K073478 — SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS
- K080094 — OLYMPUS TOTAL BHCG TEST SYSTEN
Data sourced from openFDA. This site is unofficial and independent of the FDA.