FDA 510(k) clearances — page 545
clearances on record, most recent first.
Clearances — page 545
54,401–54,500 of 175,825- K083271 — BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY
- K083347 — IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS
- K083572 — BD BACTEC Plus Aerobic/F Culture Vials
- K083657 — CONQUEST PTA BALLOON DILATATION CATHETER
- K080766 — VIDAS RUB IGG
- K081173 — ENDOSCOPIC CO2 REGULATION UNIT UCR
- K081746 — D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT
- K081768 — COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES
- K081928 — D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT
- K081971 — BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES
- K082677 — AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
- K082818 — SUBCUTANEOUS NEEDLE INFUSION SET
- K082909 — RSVP HALF SPHERE PHANTOM, MODEL DDP010
- K083049 — TORNADO ROTATABEL SNARE AND POLYP CATCHER
- K083249 — QUICKIE RHYTHM
- K083344 — HELIODENT PLUS
- K083348 — IMAGE-ARENA APPLICATIONS
- K083434 — TT1 GENERAL PURPOSE COIL
- K083474 — ZIMMER ANGLED CONTOUR ZIRCONIA ABUTMENT
- K083576 — MISER CONTRAST MANAGEMENT SYSTEM
- K083613 — QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY
- K083638 — FIXATION TROCARS
- K081008 — BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS
- K081148 — SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER
- K082637 — CRANIAL PERFORATOR
- K082651 — ENDOSSEOUS DENTAL IMPLANT SYSTEM
- K082801 — PHANTOM PLUS CAGE SYSTEM
- K082829 — AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS)
- K082926 — ZUMA, MODEL 55-XXXX/56-XXXX
- K082938 — EZLASE
- K082953 — ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01
- K083173 — VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM
- K083476 — NOVEON MODEL LS1100-03
- K083549 — ABT GLUCOSE CONTROL SOLUTION
- K081083 — CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS
- K081207 — INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM, MODEL IS2000, WITH DA VINCI CONNECT AND ONSITE
- K081309 — E.COLI/P. AERUGINOSA PNA FISH
- K081608 — PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS)
- K081751 — ADIN DENTAL IMPLANTS SYSTEM
- K081827 — HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS
- K081855 — IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS)
- K081920 — BD GENEOHM CDIFF ASSAY
- K081930 — UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
- K082086 — KEY RING ALCOHOL BREATHALYZER
- K082114 — ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00
- K082503 — DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL
- K082630 — VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES
- K082639 — ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTS
- K082643 — 3.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM ANGLED SIDE EFFECT ELECTRODE WITH INTEGRATE
- K082729 — RIMCLOSE BONE ANCHOR
- K082758 — PRISMAFLO II
- K082813 — STRYKER LED LIGHTSOURCE
- K082859 — HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED
- K082898 — AMEDICA DRUG SCREEN TEST CUP
- K082911 — SMOOTHCOOL HR SYSTEM
- K082993 — SURGISEAL TOPICAL SKIN ADHESIVE
- K083084 — CT BRAIN PERFUSION FOR ZIOSTATION
- K083254 — ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM
- K080149 — HEATER BASE, MODEL PMH7000
- K080172 — BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216
- K081355 — BIOFLEX LD-R100 TREATMENT HEAD
- K082079 — REGEN COLLAGEN SCAFFOLD (CS)
- K082233 — VIKY
- K082527 — ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREWS
- K082676 — GENADYNE A4 WOUND VACUUM SYSTEM
- K082701 — URONIRS, MODEL 2000
- K082715 — DEPUY GLOBAL AP CTA HUMERAL HEAD
- K082765 — ASTOFLO PLUS
- K082809 — ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM
- K082837 — STERILE FIELD SALINE PRE-FILLED SYRINGE(S)
- K082925 — XENON-100 SCB LIGHT SOURCE, MODEL 20132620
- K082956 — ALPHA ORTHOPAEDICS AT2 SYSTEM
- K083042 — WOUND FLUSH, STERILE WATER & NORMAL SALINE
- K083301 — X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE RETURN CATHETERS
- K083413 — COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM
- K083437 — MODIFICATION TO T2 RECON NAIL SYSTEM
- K083527 — INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS
- K080458 — MIS CREST WIDENER
- K080794 — POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
- K081165 — ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM
- K081412 — PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
- K081498 — TENSO-COMFORT BLOOD PRESSURE METER, MODELS BPM 105 AND BPM 205
- K081715 — FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM
- K081788 — INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200
- K081814 — REPROCESSED ENT SHAVERS
- K081960 — INVISALIGN SYSTEM
- K082094 — BARD PTFE (TEFLON) COATED GUIDE WIRES
- K082116 — HEMOSTASYL PASTE
- K082180 — PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440
- K082344 — STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)
- K082421 — HEARTSUITE HEMODYNAMICS 7.10
- K082481 — FLOWPICC CATHETER
- K082590 — SYMPHONY METER REMOTE
- K082625 — SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES
- K082631 — THROMBO TEK PSE, MODEL 90-480
- K082725 — GRAFTGUARD PRESSURE CONTROLLING SYRINGE
- K082731 — ML24000 UVA-1 PHOTOTHERAPY CABINET
- K082766 — MODIFICATION TO MINISPIR, SPIROLAB III
- K082783 — CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE
- K082904 — STASYS MOTION CORRECTION SOFTWARE
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