FDA 510(k) clearances — page 486
clearances on record, most recent first.
Clearances — page 486
48,501–48,600 of 175,770- K101450 — CANTATA MICROCATHETER
- K102616 — NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE
- K102663 — AED RESECTOSCOPE
- K102931 — G-CINCH SUTURE GRASPER
- K103122 — C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION, S-MAX SELLA, S-MAX SELLA 160KG
- K103153 — VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER
- K103239 — IRRIGATION SYSTEM
- K103412 — AXIOM FASCIAL CLOSURE SYSTEM
- K103668 — BNX FINE NEEDLE ASPIRATION SYSTEM
- K102279 — INCU I
- K103097 — INFRARED EAR THERMOMETER
- K103272 — ZENIUS SPINAL SYSTEM
- K103667 — SAPPHIRE ST PORTABLE DIODE LASER
- K100993 — INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLANTS
- K101837 — ACL TIGHTROPE DOUBLE BUNDLE
- K102210 — LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS
- K102746 — MIRAGE FX
- K100932 — INCLUSIVE MINI IMPLANT
- K101294 — PT2 VARIAN PROTON THERAPY SYSTEM
- K102408 — DIGITAL DIAGNOSTIC X-RAY SYSTEM
- K102572 — IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT
- K102595 — MEDISTIM VERIQC SYSTEM
- K102835 — VITAL SIGNS MONITOR
- K102937 — OSTEOPHIL BETA-TCP
- K103193 — DOSEVIEW 3D
- K103357 — LIFEBRIDGE
- K103359 — FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK)
- K103583 — DC-7 DIAGNOSTIC ULTRASOUND SYSTEM
- 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; PRONTO V4 EXTRACTION CATH
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.