FDA 510(k) clearances — page 494
clearances on record, most recent first.
Clearances — page 494
49,301–49,400 of 176,542- K103608 — I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND
- K094030 — FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030
- K100715 — AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5
- K101427 — AUDIT MICROCV HS-CRP LINEARITY SET
- K101522 — ULTRA SEAL STERILE LUBRICATING JELLY
- K101723 — COMPACT WHEELCHAIR PLATFORM
- K102134 — MODEL LA-1200 MULTI-CHANNEL LASER THERAPY SYSTEM
- K102364 — NYDIAG 200
- K102452 — DEFOGGING AND CLEANING SOLUTION- FLO-X
- K102817 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K102819 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K102837 — HIROLLER ELEVATING WHEELCHAIR
- K102910 — MODEL LUNA MANUAL WHEELCHAIR
- K103049 — TSRH SPINAL SYSTEM
- K103221 — ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5
- K103235 — ERBEFLO 2 DISPOSABLE TUBING SYSTEM
- K103303 — CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE
- K103342 — 3.0T METAFLEXCOIL
- K103406 — MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS
- K103437 — US ENDOSCOPY CYTOLOGY BRUSH
- K093715 — EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE
- K101189 — REAVILLMED PRESSURE MONITORING SYSTEM AND PICC
- K101782 — MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE
- K101861 — TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM
- K102007 — PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC,
- K102027 — AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM
- K102054 — V200 VENTILATOR
- K102281 — THERMAL MASSAGE BED, MODEL 2D-GX
- K102348 — 31P/1H DUAL TUNED SURFACE COIL 3T; 23NA/ 1H DUAL TURNED SURFACE COIL 3T; 13C /1H DUAL TURNED SURFACE COIL 3T
- K102350 — PULSE OXIMETER
- K102391 — BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM
- K102392 — MICROFUSE PUTTY AND MICROFUSE ST MIS
- K102502 — GOLIFE NASAL MASK
- K102565 — ANTERIOR APPROACH HIP SURGERY INSTRUMENTS
- K102600 — SIMPLYGO BREAST PUMP
- K102605 — MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER
- K102710 — NEO-SERVO I
- K102764 — RESOLUTION II CLIP
- K102783 — HINSON & HALE MEDICAL TECHNOLOGIES INFUSED (R) POLYESTER WRAPPERS
- K102808 — MI VARNISH
- K102972 — LIFEPAK 12
- K102992 — T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES
- K103109 — PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE
- K103405 — PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CATHETER 6F; PRONTO V4 EXTRACTION 7F
- K103464 — PACIFIC XTREME PTCA BALLOON DILATATION CATHETER
- K103466 — ARTHREX UNIVERS II SHOULDER PROSTHESIS
- K103568 — RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH
- K092844 — GEOSOURCE
- K100451 — GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132
- K100703 — STATIONARY X-RAY SYSTEM (DETECTOR) MODEL: ALTAS
- K100790 — COULTER LIN-X LINEARITY CONTROL, MODEL A81196
- K100883 — CARRIGEN
- K100937 — PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE
- K101715 — FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573
- K101982 — MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180
- K102057 — TARGON FN SYSTEM
- K102242 — OSOM C. DIFFICILE TOXIN A/B TEST
- K102410 — MATRYX INTERFERENCE SCREW (5.0-6.5MM)
- K102549 — THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY
- K102700 — LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS
- K102770 — FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW
- K102862 — NEUROVISION SE (NERVEANA)
- K102966 — 2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC
- K102997 — SONIXTABLET ULTRASOUND SCANNER
- K103093 — LEKSELL GAMMAPLAN
- K103223 — HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS
- K103502 — CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001
- K090324 — ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY
- K093762 — SYNTHES ZERO-P
- K093848 — PT-MULTI-CALIBRATOR, MODEL OPAT07
- K100850 — COWELL IMPLANT SYSTEM
- K101278 — INERTIA PEDICLE SCREW SYSTEM
- K101815 — ENDURO KNEE SYSTEM
- K101870 — SUNMAX VIETNAM CO. LTD POWDER FREE WHITE NITRILE EXAMINATION GLOVE
- K102180 — RHEAD RADIAL HEAD EXTENDED STEMS
- K102593 — SYNTHETIC, POWDER-FREE NITRILE EXAMINATION
- K102641 — MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE
- K102656 — SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM
- K102724 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K102761 — DANA REUSABLE TEST PACK FOR STEAM STERILIZATION
- K102777 — TWISTCUT ENDOSORB SCREWS
- K102875 — CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT
- K102889 — HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON
- K102969 — IMC PISTON SYRINGES
- K102977 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K102981 — ACE FREEDOM INTERNAL HEXAGON DENTAL IMPLANT SYSTEM
- K103179 — PRELUDE II TOUNGE SUSPENSION SYSTEM
- K103189 — MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK
- K103198 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K100576 — HIGH PRESSURE SETS-400 PSI
- K101563 — SMARTO
- K102106 — NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION
- K102709 — PEAK PLASMABLADE PLUS TISSUE DISSECTION DEVICE
- K102715 — REGIONAL OXIMETER
- K103360 — DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL
- K103392 — CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER
- K103432 — UNITY NETWORK ID
- K103538 — HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939
- K093299 — SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
- K100646 — AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE
Data sourced from openFDA. This site is unofficial and independent of the FDA.