FDA 510(k) clearances — page 387
clearances on record, most recent first.
Clearances — page 387
38,601–38,700 of 175,770- K121664 — T4/T5 HYTREL TOGAS
- K123276 — MM-SEAL
- K131708 — BWCSH-1 SHARPS CONTAINER
- K132267 — NEWTRON P5, NEWTRON P5 B.LED
- K132959 — DEPUY PINNACLE ALTRX ACETABULAR LINERS
- K133104 — VAN HIP FRACTURE SYSTEM
- K133196 — IMPACT MODEL 323 ASPIRATOR
- K133469 — ACUMED SUTURE ANCHOR SYSTEM
- K133864 — DERMABOND PRINEO SKIN CLOSURE SYSTEM
- K140267 — ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM)
- K140328 — CMC MINI TIGHTROPE
- K131959 — HEINE MINI 3000(R) OPHTHALMOSCOPE
- K132107 — MALE LATEX CONDOM
- K132945 — CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CANNULATED HUMERAL NAIL
- K133135 — IMPAX VOLUME VIEWING 3.0
- K133214 — BLACKBIRD SPINAL SYSTEM
- K133363 — INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM
- K133436 — FLASH AR; FLASH AR QUICK
- K133527 — SUFLEX PUTTY, SUFLEX HEAVY, SUFLEX MONO, SUFLEX LIGHT
- K133713 — CHARLOTTE (TM) SNAP-OFF SCREW
- K134026 — ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT
- K140093 — TABLE
- K140148 — PRO-TOE HAMMERTOE FIXATION SYSTEM
- K140286 — OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER
- K140291 — VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS
- K140323 — NAVIGATOR HD URETERAL ACCESS SHEATH SETS
- K131506 — AIRWAY SUPPORT SYSTEM / AIRPORT
- K131562 — BREATHE NIOV VENTILATION SYSTEM
- K131627 — CATHETER INTRODUCER SHEATH
- K131750 — AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM
- K131912 — CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN
- K132244 — N-FORCE FIXATION SYSTEM
- K132611 — MICROTABLE SYSTEM
- K132812 — UCP MULTI-DRUG TEST KEY CUPS
- K133022 — ZEDVIEW
- K133036 — APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS
- K133400 — FLASH BITE
- K133459 — ELITE IBF
- K133754 — INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER
- K133836 — OPTIGLAZE COLOR
- K133966 — MODEL-BASED RSA SOFTWARE
- K140113 — O2 NASAL CANNULA WITH CO2 MONITORING
- K140153 — VENTRIPOINT MEDICAL SYSTEM
- K130751 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K131900 — CONTEC ELECTROCARDIOGRAPH
- K132714 — ISENS (POLYMACON) SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES (CLEAR, TINTED, AND COSMETIC TINTED)
- K132926 — VELOFIXTM INTERBODY FUSION SYSTEM
- K133254 — REVLITE Q-SWITCHED ND:YAG LASER SYSTEM
- K133292 — ALLURA XPER FD; OR TABLE
- K133445 — ANGIOVAC CANNULA
- K133618 — DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM22 SERIES
- K133619 — DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM18 SERIES
- K133740 — SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI MULTIFOCAL WITH TINT
- K140208 — FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII
- K140258 — IMMULITE 2000 DHEA-SO4; THIRD GENERATION TSH AND INTACT PTH CALIBRATION VERIFICATION MATERIAL
- K140263 — INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT
- K140266 — NMI PICC IV
- DEN080009 — AIRPURGE
- K131788 — HEALTHSTATS A-PULSE CASPAL + AND MC3100+ MONITORS AND MY-BP BP MANAGEMENT APPLICATION SOFTWARE
- K132908 — TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT
- K132936 — NOVOPORE DRESSING
- K133028 — RITHM ID ELECTROPHYSIOLOGY CATHETER
- K133117 — ANDON BLOOD PRESSURE CUFF
- K133339 — ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED;ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT, HA COATED
- K133383 — HEM-7320
- K133472 — SAUFLON CLARITI 1 DAY WITH TINT (TORIC/MULTIFOCAL)
- K133525 — LOCKING COMPRESSION BONE PLATES AND SCREW SYSTEM
- K140099 — LIGHTHOUSE URINARY CATHETER
- K140126 — SONIC WINDOW
- K123193 — IPM WOUND GEL BIO
- K130618 — SFI-ANCHOR
- K131402 — VISICLEAR SMOKE EVACUATION SYSTEM
- K131659 — MOERAE VEIN PREPARATION KIT
- K132800 — SKINTELL
- K133547 — NXSTAGE SYSTEM ONE WITH NXVIEW
- K133668 — AFT GREATER TUBEROSITY FRACTURE PLATE, LEFT, AFT GREATER TUBEROSITY FRACTURE PLATE, RIGHT, AFT GREATER TUBEROSITY CANNUL
- K133937 — HEARTSCAN SOFTWARE
- K130255 — HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS
- K130847 — JINTRONIX REHABILITATION SYSTEM (JRS)
- K130982 — LERADO, POWER WHEELCHAIR
- K131334 — HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST
- K131548 — SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM
- K131605 — ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY
- K131727 — CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM
- K131777 — HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM
- K131896 — SUPERVAN 1.5T MAGNETIC RESONANCE IMAGING SYSTEM
- K132064 — BIOMARC FIDUCIAL MARKER
- K132469 — THE BITE GUARD
- K132580 — COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE
- K132763 — ADVANCED VIEWER
- K132810 — GLADIATOR ELITE PTA BALLOON DILATATION CATHETER
- K133090 — OXICARE FINGERTIP PULSE OXIMETER
- K133119 — FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS
- K133158 — ND: YAG LASER SYSTEM
- K133451 — FIXOS SCREW SYSTEM
- K133609 — THE DOME S6C
- K133654 — SCENIUM
- K133671 — ICONIX ALL SUTURE ANCHORS
- K133702 — PRESTO BREAST BIOPSY DEVICE
- K133715 — CHARLOTTE CLAW PLATE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.