FDA 510(k) clearances — page 594
clearances on record, most recent first.
Clearances — page 594
59,301–59,400 of 176,637- K061828 — LORENZ BIOTECH APTIVA, VERSION 2.13
- K070787 — LATITUDE ELBOW PROTHESIS
- K071010 — TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS
- K071029 — CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS)
- K071263 — NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500
- K071274 — GSO GS1 SPACER
- K071336 — ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307
- K071424 — PMAX NEWTRON XS
- K071476 — SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP
- K071530 — KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM
- K071811 — ETOH FLEX REAGENT CARTRIDGE (DF22)
- K071902 — AMS MINIARC SLING SYSTEM
- K071913 — IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01
- K072210 — CHISON, MODEL 8300
- K062865 — SMALL VOLUME SYRINGE
- K063607 — SPINEASSIST SYSTEM
- K070158 — R-PORT LAPAROSCOPIC ACCESS DEVICE
- K070988 — SC PROFI FINE PEN NEEDLE, MODELS; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G)
- K071908 — DOCTOR'S LIGHT LED DENTAL CURING LIGHT
- K071936 — WOUNDSTAT, MODEL TC1001
- K072195 — THROMCAT THROMBECTOMY CATHETER SYSTEM
- K072207 — DURAGEN XS DURAL REGENERATION MATRIX
- K072220 — PEDI CO2 EASY
- K072234 — THERMOGARD XP THERMAL REGULATION SYSTEM
- K062623 — AXIOM LUMINOS DRF
- K070918 — 4DDOME
- K070962 — CORAL PEDICLE SCREW SYSTEM
- K071172 — MODIFIED MERCI RETRIEVER, MODEL 90060
- K071350 — DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
- K071422 — 15.5F HEMO-STREAM HEMODIALYSIS CATHETER SET
- K071531 — MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
- K071648 — EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS
- K071686 — POWDERED VINYL PATIENT EXAMINATION GLOVES
- K071703 — ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC
- K071872 — VELASHAPE
- K072012 — REFLEXION SPIRAL VARIABLE RADIUS CATHETER
- K063190 — SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC
- K063729 — DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00
- K070185 — TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA RED, 660-001
- K070708 — OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104
- K070780 — CONMED LINVATEC XO BUTTON
- K070981 — SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (PLASMAPORE)
- K071438 — PSS SYSTEM
- K071461 — MODEL 300D HOME OXYGEN LIQUEFIER
- K071548 — WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED
- K072175 — TITANIUM HIP TOOL LOCKING PLATE
- K070376 — CONMED LINVATEC 300W XENON LIGHT SOURCE
- K071032 — ARTHREX UNIVERS II SHOULDER PROSTHESIS
- K071316 — MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN
- K071317 — MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-GENTAMICIN SYNERGY SCREEN
- K071361 — R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001, 002,004,005
- K071380 — MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM
- K071623 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, AMPICILLIN-SULBACTAM (GN) 1/0.5-32/16 UG/ML
- K071822 — URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12
- K072027 — FORU KV10HB
- K072096 — CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04
- K070002 — BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER
- K070034 — REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES
- K070036 — REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES
- K070267 — DEPUY GCK TIBIAL COMPONENTS
- K070970 — NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F
- K071190 — ROOT ZX II
- K071320 — EVERLIFE POWERED MUSCLE STIMULATOR, MODEL E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311
- K071404 — SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE
- K071518 — DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS
- K071586 — BIORAPTOR 2.3 PK SUTURE ANCHOR
- K071669 — INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP
- K071790 — GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, JOURNEY BCS KNEE SYSTEM
- K071834 — STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM
- K071985 — GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND
- K072060 — QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V
- K072089 — ARTHROCARE SPINEWAND
- K072104 — HEARTWAY POWER MOBILITY SCOOTER, PF6
- K072131 — M3 MONITOR
- K072165 — VICTORY THREE WHEEL SCOOTER, MODEL: SC610
- K060980 — VENDYS MODEL 5000 B/BC
- K063447 — INSIGHT DISCOVERY
- K063671 — REBOUND HRD
- K063836 — RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND 41704-41715
- K070020 — COMCASET-P SAFETY IV CATHETER
- K070135 — VITRIFREEZE MEDIUM; VITRITHAW MEDIUM
- K071126 — CRYOSEAL FS APPLICATOR SYSTEM
- K071308 — MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM
- K071459 — B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES
- K071894 — XEBRA DICOM IMAGE BROWSER
- K061880 — ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC
- K062489 — APEX HCLA ACETABULAR CUP LINERS
- K063323 — SPECTROLYSE PAI-1, MODEL 101201
- K063759 — HEATMARKER TIME TEMPERATURE INDICATOR
- K070005 — HEMOSIL RECOMBIPLASTIN 2G
- K070023 — MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-100
- K070151 — INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR AND KNOTTING ELEMENT APPLIER
- K070826 — KD-795 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR
- K070828 — KD-595 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
- K071138 — CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM
- K071266 — BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS
- K071410 — ARGEN PEARL BRAND ZIRCONIA
- K071469 — INOLASE SERENITY PSF ( PNEUMATIC SKIN FLATTENING) SYSTEM
- K071477 — REVERTO 55 AND 37 SHAPE MEMORY STAPLES
- K071496 — ICATH, STERILESURE
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