FDA 510(k) clearances — page 484
clearances on record, most recent first.
Clearances — page 484
48,301–48,400 of 175,770- K103511 — LITECURE THERAPY SYSTEM
- K103612 — DIMENSION VISA ENZ 2 CAL
- K103616 — PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER
- K103805 — MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE
- K103815 — Q-STATION
- K100591 — SORBACT
- K100823 — WOUND PRO APEX
- K101604 — VSI MICRO-INTRODUCER SETS (REGULAR, STIFFEN), MODELS 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274V
- K102123 — VIZION DR
- K102218 — COMPACT PIEZO P2K, POWERCARE
- K102336 — RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS WITH NE
- K102670 — TOTAL SHOULDER SYSTEM
- K103157 — DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE
- K103231 — KYPHON INFLATION SYRINGE
- K103332 — APTUS ULNA PLATES
- K090626 — ENDOSERTER
- K090754 — LIPOCONTROL
- K093101 — MAGO 4S
- K100625 — REALEYE MODEL VCPS
- K100957 — DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS), MODEL 66, DEPLOYABLE OXYGEN CEONCENTRATION
- K101147 — MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM
- K101354 — FETCH 2 ASPIRATION CATHETER MODEL 109400-001
- K101894 — HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT
- K102154 — TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS
- K102227 — INFA WARMER I
- K102775 — HAMILTON-C2
- K102870 — EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM
- K103141 — LOW ADHERENT AFM AG DRESSINGS
- K103243 — 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM
- K103529 — LIAISON XL ANALYZER MODEL 10050
- K103580 — GRANDIO SO FLOW
- K103746 — CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD)
- K103755 — TAPERLOC COMPLETE, SIZE 5 AND 6
- K110131 — LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE
- K100585 — MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900
- K100610 — LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS
- K101446 — EMERALD SPINAL SYSTEM
- K102153 — MOBIUS ULTRASOUND IMAGING SYSTEM
- K102203 — CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS
- K102743 — ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES
- K102814 — ELECYSYS SHBG
- K102893 — PCP/PC STETHOSCOPE
- K102914 — TQ HBA1C GEN3
- K102940 — VASCOPRESS SEQUENTIAL DVT PUMP
- K103017 — MEDERI THERAPEUTICS RF GENERATOR CONTROL MODULE
- K103351 — DMC COMPOSITE 2
- K103468 — STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS)
- K103539 — QUANTA SYSTEM DUOLITE
- K103715 — COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE
- K103762 — SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE
- K110020 — TERASON T3200 ULTRASOUND SYSTEM
- K102165 — STERILE SALINE SOLUTION
- K102195 — SP-FIX SPINOUS PROCESS FIXATION PLATE
- K102370 — R3 XLPE ANTEVERTED LINERS
- K102594 — IO-FLEX CATHETER
- K103080 — ALBOGRAFT VASCULAR PROSTHESIS
- K103250 — CPS DIRECT SL II SLITTABLE OUTER CATHETER
- K103533 — ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM
- K103710 — WBR XPRESS PET
- K083894 — ALIF SPINAL TRUSS INTERBODY FUSION DEVICE
- K093627 — IPULSELIGHT IPL SYSTEM, MODELS HS 300C AND HS 650
- K101599 — RVT CTO DEVICE
- K102979 — NEXGEN PERIPHERAL GUIDE CATHETER
- K103133 — VEPER SYSTEM, EXPEDIUM SYSTEM
- K103334 — CARDIO MED
- K103469 — STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05
- K092963 — GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3
- K100649 — SOUNDBITE HEARING SYSTEM BY SONITUS
- K100829 — EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520
- K101216 — AUDIT MICROCV PROTEIN LINEARITY SET
- K101336 — E1 AVANTAGE HEAD
- K102077 — MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
- K102385 — NORFOLK MEDICAL NORPORT FAMILY OF PORTS
- K102432 — DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL,
- K102584 — IMC HYPODERMIC NEEDLE
- K102589 — CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER
- K102601 — ORTHOFLEX ROD
- K102857 — AHWON'S IPL SYSTEM
- K102864 — 84E SERIES SINGLE PLY WRAPPER
- K102885 — HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX
- K102934 — INFRARED EAR THERMOMETER, MODEL IR-04MT
- K102959 — PROLYTE ELECTROLYTE ANALYZER
- K103032 — ESG-400 MODEL WB95051N, FOOTSWITCH DOUBLE PEDAL MODEL WB50402W, FOOTSWITCH SINGLE PEDAL MODEL WB50403W, P-CORD MODEL MAJ
- K103068 — KING COBRA ANTERIOR CERVICAL PLATE
- K103088 — GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT
- K103182 — TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
- K103353 — MULTIPURPOSE DRAINAGE CATHETER; NEPHROSTOMY DRAINAGE CATHETER; BILIARY DRAINAGE CATHETER
- K103501 — ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES
- K103688 — G-PROX EZ ENDOSCOPIC GRASPER
- DEN090011 — HEM-AVERT PERIANAL STABILIZER
- K093678 — PLATELIA ASPERGILLUS EIA MODEL 62793
- K100891 — DANA EMULATING INDICATOR
- K101614 — HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809
- K102140 — FETAL MONITORS, MODELS F2 AND F3
- K102460 — AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH
- K102590 — FLEBOSET DOUBLE
- K102613 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K102836 — BONASIL A+ IMPRESSION MATERIALS
- K102861 — SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE)
- K102996 — MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR
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