FDA 510(k) clearances — page 592
clearances on record, most recent first.
Clearances — page 592
59,101–59,200 of 176,637- K071453 — SPI EASY 4.0 ABUTMENT
- K071604 — ALVEOLUS AERO DV TRACHEOBRONCHIAL STENT SYSTEM
- K071823 — PERMA FACIAL IMPLANTS
- K071929 — NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL
- K072181 — MINI LED AUTOFOCUS
- K072283 — DORADO PTA BALLOON DILATATION CATHETER
- K072304 — FIBRINOGEN CALIBRATOR KIT
- K072364 — PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES
- K070387 — EXPEDIUM SPINE SYSTEM
- K070670 — EYETRACKER/IDEAS
- K071546 — EOS
- K071553 — ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR
- K071832 — MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM
- K071887 — SPORTMESH OR ARTELON TISSUE REINFORCEMENT
- K071922 — INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC
- K072184 — VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE
- K072315 — MIDAS REX CURVED BUR
- K072317 — MODIFICATION TO:TSRH SPINAL SYSTEM
- K072322 — ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS
- K072357 — NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEM
- K072389 — MODIFICATION TO HYPERQ SYSTEM
- K070804 — VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST
- K070897 — BONEMEDIK, AND BONEMEDIK-S
- K070927 — HEMOSIL D-DIMER HS
- K071157 — STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS
- K071428 — INQU
- K071704 — SLEEVE AND BUTTON SOFT TISSUE DEVICES
- K071797 — MONDEAL HAND CONTOUR SYSTEM
- K071798 — MONDEAL DISTAL RADIUS SYSTEM
- K071877 — LANX SPINAL FIXATION SYSTEM
- K071971 — DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL
- K072316 — PRECIOUS PLUS GUIDE CATHETER
- K062736 — SIASCOPE V
- K063048 — TRANS-CATHETER EXTRACTOR
- K063259 — OLYMPUS CAPSULE ENDOSCOPE SYSTEM
- K063481 — MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM
- K070685 — KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662
- K070742 — MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
- K070812 — DISPOSABLE LAPAROSCOPIC INSTRUMENT
- K071067 — BACTRACK LCD ALCOHOL DETECTOR
- K071170 — POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR COATED WITH ALLOGEL
- K071239 — TOTAL PROTEIN URINE/CSF GEN.3
- K071449 — BRM3 BRAIN MONITOR
- K071499 — COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY
- K071567 — AUTOSAFE-REFLEX SAFETY NEEDLE, AUTOSAFE ADVANTAGE SAFETY NEEDLE
- K071651 — EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES
- K072090 — SIEMENS DIAGNOSTIC ULTRASOUND SYSTEMS
- K072246 — VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601
- K072282 — CAPLESS LI PEDICLE SCREW SYSTEM
- K072320 — GREINER VACUETTE QUICKSHIELD COMPLETE
- K072439 — GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT
- K072445 — INTEGRATED BRACHYTHERAPY UNIT - DIGITAL
- K070361 — MRSASELECT
- K070640 — ARCHITECT STAT TROPONIN-1; MYOGLOBIN
- K071082 — STRYKER MODULAR HIP SYSTEM
- K071891 — STATIS DENTAL HANDPIECES
- K072150 — DIMER ACID DERIVED NANO-HYBRID COMPOSITE RESTORATIVE MATERIAL
- K072278 — BRK TRANSSEPTAL NEEDLE
- K072387 — KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES
- K072405 — USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE
- K072539 — CURE CATHETER
- K063609 — RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER
- K063658 — INTRAVASCULAR INTRODUCER SYSTEM
- K070653 — KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662
- K070859 — REPROCESSED ETHICON ETS ENDOSCOPIC LINEAR CUTTERS
- K071272 — TROJAN THINTENSITY BRAND MALE LATEX CONDOM
- K071321 — POCKETCPR
- K071437 — MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 2870719C, 2870723C, 2870823C, 2870828C, 2870928C
- K071644 — ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620
- K071650 — C350 POWERED WHEELCHAIR
- K071672 — SENTEC DIGITAL MONITORING SYSTEM
- K071773 — CPAP NASAL MASK WITH PILLOWS
- K072021 — NEOPIP INFANT RESUSCITATOR
- K072023 — ELLIPSE JUVIA, MODEL 9EJU7465
- K072038 — VITEK 2 GRAM NEGATIVE LEVOFLOXACIN
- K072297 — BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM
- K072308 — D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATED
- K072394 — PORTRAIT STAND-OFF
- K072418 — OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBER
- K062644 — FLEXWARMER, MODELS KZ-1 AND KZ-2
- K070554 — DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS
- K070590 — MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT19S1R
- K071121 — TRIBONE 80
- K071379 — DELTA XTEND REVERSE SHOULDER MODULAR STEM
- K071465 — BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENT
- K071612 — MODUS TRILOCK 2.0/2.3/2.5
- K071614 — FIDUCIAL MARKERS
- K071700 — BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENT
- K071980 — DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H
- K072151 — P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS
- K072242 — COR ANALYZER II, MODEL V1.7
- K070694 — CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS)
- K071414 — BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K071429 — TI2200 TRANSILLUMINATION CABLE
- K071471 — CORIN ADAPTOR SLEEVE
- K071486 — RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053
- K071507 — PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS
- K071541 — SBI TWISTOFIX
- K071565 — BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT
- K071575 — SANDMAN INTRO
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