FDA 510(k) clearances — page 459
clearances on record, most recent first.
Clearances — page 459
45,801–45,900 of 175,770- K113112 — CLEARWAY RX NB CATHETER
- K113125 — INTELLIVUE MX40 PATIENT MONITOR
- K113191 — POWER FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
- K113234 — MOBCARDIO SYSTEM
- K103818 — CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY
- K110770 — HEALTHTRACKER
- K111026 — APOLLO
- K111323 — SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS
- K111773 — RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE
- K111955 — MEDLINE PNEUMOPERITONEUM NEEDLE
- K112167 — SOYALA SILKGEL FULL FACE MASK
- K112205 — SNORERX 9.0
- K112276 — VIZION
- K112280 — STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUM
- K112393 — TASMAN
- K112639 — THE BELMONT BUDDY LITE FLUID WARMER
- K112640 — HYPERELASTIC WIRE
- K113195 — POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K113212 — DENTAL LASER THERAPY SYSTEM
- K111005 — ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIAL
- K111600 — REPROCESSED HAND ACTIVATE SEALER/DIVIDER
- K112069 — RSP GLENOID BASEPLATE POROUS COATED
- K112444 — ANATOMIC PEEK CERVICAL FUSION SYSTEM
- K112453 — STERISPINEPS PEDICLE SCREW
- K113156 — SONOSITE EDGE ULTRASOUND SYSTEM
- K102413 — FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL
- K111840 — EMERGE FRACTIONAL LASER
- K111843 — ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM
- K112111 — ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR
- K112406 — PERI-LOC PROXIMAL FEMUR LOCKING BONE PLATES
- K112839 — VARIAN HIGH ENERGY LINEAR ACCELERATOR
- K113263 — ARGES IMAGING CONTRAST SPRAY
- K113279 — IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT
- K102925 — NEXGEN EXPANDABLE CATHETER
- K103031 — BMR FACE
- K103058 — MULTIFUNCTION KEITO
- K110463 — PCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS)
- K111487 — NH-301 AMBULATORY ECG ANALYSIS SOFTWARE
- K111557 — X-FORCE
- K111716 — KNOTLESS SUTURE FIXATION SYSTEM
- K111764 — CHARTIS CONSOLE
- K111932 — IGLUCOSE SYSTEM
- K111984 — SPI VARIO ANGLED ABUTMENT
- K112321 — CS 1200
- K112357 — VESSEL GUARDIAN
- K112475 — XTRACT SYRINGE KEY SYSTEM
- K112558 — DIGITAL FLAT PANEL X-RAY DETECTOR
- K112838 — VASOPRESS REPROCESSED DVT LEG / FOOT GARMENTS
- K113019 — PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER
- K113046 — AMEDITECH IMMUTEST MILTI-DRUG SCREEN
- K113063 — CT-GUIDE NEEDLE GUIDANCE SYSTEM
- K102752 — STINGRAY ULTRALITE DISPOSABLE IRRIGATING BIPOLAR FORCEPS
- K103575 — SPIRO PD
- K110276 — POWERPRESS UNIT
- K110442 — NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM
- K110562 — TELAMON PEEK SPINAL SYSTEM
- K111097 — HUMELOCK CEMENTED SHOULDER PROSTHESIS
- K111210 — T:SLIM (TM) INSULIN DELIVERY SYSTEM
- K111356 — ASIMANAGER - AT
- K111509 — SWEETSPOT DIABETES DATA MANAGEMENT SERVICE
- K111645 — FD TENS 2050 OR SLIDE TENS MODEL FD2050
- K111901 — ASA 'MPHI FAMILY DIODE LASER
- K112152 — CERCON HT
- K112190 — PATIENT MONITOR
- K112303 — RUBICON SUPPORT CATHETER
- K112416 — CPK REAGENT
- K112601 — INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER
- K112688 — ENSITE VELOCITY SYSTEM V.3.0
- K112985 — CATHETER CONNECTIONS' DUALCAP DUO
- K112988 — POWDER FREE LATEX PATIENT EXAM GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS PER DM SQUARED OR LESS OF WATER SOLUBLE
- K113110 — AXERA ACCESS SYSTEM
- K102741 — ENTERAL FEEDING BAG AND SETS
- K103788 — PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT
- K110612 — FM20
- K111267 — CONCISE, SILICONE HYDROGEL DAILY WEAR SOFT CONTACT LENS (EFROFILCON A)
- K111273 — FIR HEAT THERAPHY SYSYEMS
- K111615 — SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES
- K111692 — TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC
- K111930 — ACKERMANN EUROPCLIP
- K112033 — ENSEAL G2 TISSUS SEALERS
- K112036 — CALIX PC SPINAL IMPLANT SYSTEM
- K112186 — FIBER DISK AND BLOCK
- K112359 — PROW FUSION
- K112447 — GRANDIO CORE DUAL CURE
- K112957 — HI-TORQUE POWERTURN
- K113129 — SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM)
- K101863 — IT/IF CONTROL
- K103472 — NUFACE PLUS
- K111882 — LAMINAR FLOW PHACO TIPS
- K112068 — SYNTHES ZERO-P VARIABLE ANGLE (VA)
- K112145 — MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS33I2
- K112602 — S6 DIAGNOSTIC ULTRASOUND SYSTEM
- K100811 — IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400
- K103021 — ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM
- K103291 — BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE
- K110246 — MEDISIZE RED AND MEDISIZE BLUE
- K110715 — INTERDRY SILVER
- K110765 — FXA (TM)
- K111161 — PERFSCAPE V2.0
- K111392 — WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE)
Data sourced from openFDA. This site is unofficial and independent of the FDA.