FDA 510(k) clearances — page 704
clearances on record, most recent first.
Clearances — page 704
70,301–70,400 of 175,825- K033602 — INSORB ABSORBABLE STAPLE, MODEL SP-B20
- K033793 — CLEANER II ROTATIONAL THROMBECTOMY SYSTEM
- K032171 — ACCUSOFT
- K032422 — EUSOL-C
- K032679 — AEQUALIS SHOULDER FRACTURE SYSTEM
- K032902 — SUBTALAR ARTHRORISIS IMPLANT
- K032955 — AUTOMOVE, MODEL AM800
- K033306 — PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
- K033322 — MODIFICATION TO CD HORIZON SPINAL SYSTEM
- K033348 — ZILVER 518 BILIARY STENT
- K033604 — TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L
- K033624 — PACS SOFTWARE SOLUTION 2003
- K033631 — MODIFICATION TO COATEST FACTOR VIII
- K033701 — FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES
- K033740 — LORENZ STERNAL CLOSURE SYSTEM
- K033748 — TRIDENT RESECTION ABLATOR
- K031169 — MOTILITY VISUALIZATION SYSTEM
- K031812 — TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03
- K032102 — VERTELINK KOBRA SPINAL FIXATION SYSTEM
- K032104 — AMNIOLENS
- K032866 — CLARITY PET
- K032952 — AIACT KIT
- K033063 — MISSION CONTROLS
- K033166 — KACEY INSULIN SYRINGE
- K033230 — TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA
- K033234 — IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER
- K033298 — SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELS
- K033299 — ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE
- K033366 — LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454; POSITIVE, MODEL 455
- K033398 — LARYNGEAL AUGMENTATION IMPLANT
- K033404 — LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES)
- K033562 — FASTRAC GASTRIC ACCESS PORT KIT
- K033583 — PROGREAT
- K033640 — SIROSON L AND SIROSONIC L ULTRASONIC SCALERS
- K033735 — VANTAGE PRO ATTENUATION CORRECTION DEVICE
- K033752 — BRUNO ELECTRA-RIDE STAIRWAY ELEVATOR SYSTEM. MODEL SRE-1540
- K031077 — VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM
- K031612 — ALT LASER, MODEL VTR 75
- K032205 — RADIANCY ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT ASSEMBLY
- K032268 — MBCP
- K032835 — H/S CATHETER SET
- K032846 — SPECTRA PULSED DIODE LASER, MODEL DR-1
- K033424 — ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002
- K033600 — INFINITY GAMMAXL
- K033641 — SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800
- K033680 — M2376A PHILIPS DEVICE LINK SYSTEM
- K033681 — GLIDESHEATH
- K033708 — MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
- K033714 — MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING
- K031949 — TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75
- K032719 — GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING)
- K032720 — GEM-STIM TENS, MODELS GM3XY AND GM3AXY
- K032757 — A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE
- K032829 — SCORPIO LOW PROFILE TIBIAL TRAY
- K032841 — MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR
- K032855 — STRYKER SPINE MAPS SYSTEM
- K032953 — EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT
- K033025 — TYTAN PROFESSIONAL /ECONOMY SERIES SPHYGMOMANOMETER, NO 710/NO 700
- K033110 — C-GRAFT
- K033269 — ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD
- K033392 — IMMEDIATE STABILIZING IMPLANT (ISI)
- K033537 — SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, AND EX8S3005
- K033544 — ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607
- K033586 — MODIFICATION TO AURORA DS
- K033669 — SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS)
- K030370 — REDLINE ANTHRAX ALERT TEST
- K031599 — CD LEYCOM PRESSURE/VOLUME CATHETERS
- K031643 — SPIROTEL, MODEL 29-1020
- K032208 — MONA LISA ASPIRATION NEEDLE
- K032690 — MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM
- K033156 — OB1 OBSTETRICAL DOPPLER
- K033184 — LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400
- K033737 — ALLURA XPER FD20
- K031018 — AUTOGEL PAD
- K031094 — FLUID FILLED TEETHERS
- K032812 — ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT
- K032827 — KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501
- K032970 — ACRA-CUT XPRESS 120
- K033137 — POTENS +
- K033568 — GYNECARE TVT OBTURATOR SYSTEM
- K033613 — MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
- K023414 — MIDA ALGORITHM REV. B
- K030829 — VPT METER
- K031649 — SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES
- K032222 — IMMUNOCARDSTAT HPSA
- K032810 — DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE
- K032821 — HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF
- K033519 — CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET
- K033520 — BLUEPHASE
- K033542 — EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE
- K033610 — HDL-CHOLESTEROL PLUS 2ND GENERATION
- K021692 — CLC2000 CATHETER PATENCY DEVICE
- K023023 — LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSERTION KIT, ACCESS CANNILA
- K024014 — RANDOX RX DAYTONA
- K031124 — POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR
- K031733 — NON-CONTACT TONOMETER, MODEL NT-4000
- K032309 — NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY
- K032362 — UP-GRADE FOREHEAD THERMOMETER
- K032659 — DEPUY ASR RESURFACING FEMORAL HEADS
- K032756 — A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533
Data sourced from openFDA. This site is unofficial and independent of the FDA.