FDA 510(k) clearances — page 423
clearances on record, most recent first.
Clearances — page 423
42,201–42,300 of 175,770- K122048 — COLLAGEN TENDON SHEET-D
- K122698 — AEQUALIS ASCEND FLEX SHOULDER SYSTEM
- K123180 — FALCON SPACER
- K123371 — ALIGNRT PLUS
- K123476 — MEGA 5.5 SPINE SYSTEM
- K123847 — MALLEABLE TIP ENDOSCOPIC APPLICATOR
- K123868 — INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET
- K121585 — TS IMPLANT SYSTEM
- K121752 — AVIE TOTAL HB TEST SYSTEM
- K121991 — ENTEROCOCCUS QUICKFISH BC
- K122288 — BRAINSWAY DEEP TMS SYSTEM
- K122643 — VANTAGE MODEL V5000, V5100, V5000C, V5100C
- K113516 — THERASOM-CAST
- K113787 — DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
- K122592 — INSTINCT JAVA SYSTEM
- K122818 — OLYMPUS MAJ-172 INSTRUMENT TRAY FOR LTF VIDEOSCOPE
- K122854 — ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER
- K122976 — BODY FAT SCALE MODEL SF-371
- K123388 — K7C SPACER
- K123731 — BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY
- K100695 — COLLADENTAL BARRIER
- K121108 — DOPPLEX ABILITY
- K121975 — AIRVO HUMIDIFIER MYAIRO HUMIDIFIER
- K122237 — BIOPHOTAS LIFELIGHT
- K122483 — PEARL DIABETES MANAGEMENT SYSTEM
- K122943 — MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER
- K123102 — SOVEREIGN MINI
- K123194 — JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-0088
- K123363 — SUPER STAPLE(TM) CLASSIC
- K123439 — NEO ERCP GUIDEWIRE
- K123452 — TRACKER-17 MICROCATHER, 150 CM LONG AND 15.0 CM FLEXIBLE DISTAL SHAFT, TRACKER-17 MICROCATHETER, 150 CM LONG AND 7.5 CM
- K123712 — RETRACTA DETACHABLE EMBOLIZATION COIL
- K123759 — CG+ ARROW PICC POWERED BY ARROW VPS STYLET
- K121296 — INTERVENTIONAL WORKSPOT
- K122273 — MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS
- K122457 — GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS
- K123877 — QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
- K121944 — LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT
- K122919 — DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA
- K122111 — RESPIRONICS SIMPLYCLEAR DEVICE
- K122481 — LIPIVIEW OCULAR SURFACE INTERFEROMETER
- K121007 — NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1
- K121297 — ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULAR
- K121397 — OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT
- K122474 — LANSINOH POWERED ELECTRIC BREAST PUMP
- K122764 — RAPID STRAND RX
- K123167 — DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEM
- K123357 — ONQ RTS
- K120490 — QUICK SAMPLER HOLDER
- K121549 — NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE
- K121653 — INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS
- K121661 — EZ-ASSIST-FILL
- K121693 — A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS)
- K121710 — XPERT CT/NG
- K122039 — KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B
- K122134 — FLEXLITE CAMERA
- K122749 — PRESTIGE-MOBIE
- K122784 — NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT
- K122909 — SYNGO SINGLE SOURCE DUAL ENGERY
- K123091 — VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T
- K123419 — EVA SELECT DIGITAL DENTAL IMAGING SYSTEM
- K123526 — CLEARREAD +CONFIRM
- K123591 — FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH)
- K123663 — LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK
- K123683 — NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR
- K123017 — STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324
- K112898 — DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS
- K113010 — FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR
- K113023 — STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER
- K120391 — MR4500 WHEELCHAIR
- K120475 — ANESTHESIA CONDUCTION NEEDLES
- K120793 — Z-LOOK3 EVO SLM
- K120822 — STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARIOBASE ABUTMENT RN, STRAUMANN CARES VARIOBASE ABUTMENT WN, ST
- K120948 — PREXION 3D
- K121003 — ABBOTT PLEX-ID FLU ASSAY
- K121077 — NHANCER
- K121555 — CENTURION VISION SYSTEM
- K122106 — SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP TRACKED ASPIRATION NEEDLE
- K122142 — GLOOKO LOGBOOK CHARTS
- K122414 — AB COMMAND DUAL CHANNEL FITNESS BELT
- K122609 — VASCULAIRE COMPRESSION SYSTEM MODEL FLS-0003; VASCULAIRE SLEEVE (FOOT & CALF) MODEL FLS-0002; VASCULAIRE SLEEVE (CALF) F
- K122616 — PANTHER OIS/R & V MODEL VERSION 2.0
- K122690 — ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE
- K122717 — FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK
- K122897 — SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645
- K122944 — GEMORE TRUE SINE INTERFERENTIAL STIMULATOR
- K122948 — GEM-STIM COMBO STIMULATOR
- K122961 — WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500)
- K123000 — INTEGRA TOTAL FOOT SYSTEMS
- K123092 — CERAMIN BRACKETS Z
- K123172 — KOGENT BIPOLAR FORCEPS
- K123191 — XPERT FLU
- K123260 — DETACHATIP III
- K123341 — ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON, ARTHREX PROXIMAL BICEPS BUTTON
- K123611 — E-CUBE 7
- K123616 — PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM
- K123637 — HAMILTON-C3
- K123669 — TRANSTEK WRIST BLOOD PRESSURE MONITOR
- K123729 — VERSARATE FLOW RATE CONTROLER
- K123754 — CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.