FDA 510(k) clearances — page 375
clearances on record, most recent first.
Clearances — page 375
37,401–37,500 of 175,770- K141173 — AMPLIVUE GAS ASSAY
- K141489 — LINOS MOH HAND PLATING SYSTEM
- K141711 — PONTIS 3MM SUTURE ANCHORS WITH ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE SUTURE, PONTIS ULTRA-HIGH MOLECULAR WEIGHT POLYE
- K141750 — HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM
- K132820 — VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES
- K133306 — SIS HERNIA GRAFT
- K133535 — INFX-8000V, V5.30
- K133759 — INTELLIJOINT HIP
- K140552 — CADWELL SPIKE AND SEIZURE DETECTOR
- K140578 — ARTHROSCOPIC ENERGY SYSTEM
- K140775 — TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM
- K141049 — IFUSE IMPLANT SYSTEM
- K141208 — DYNAMIC NEUROSCREENING DEVICE
- K141256 — OKAMOTO STUDDED CONDOM
- K141284 — CASPIAN SPINAL SYSTEM
- K141784 — ORTHO SOLUTIONS ULTOS PLATING SYSTEM
- K130097 — MEDMATE TRANSFER ADAPTER AM5500 & AM5500-NS
- K131721 — EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1
- K133364 — PICOSURE WORKSTATION
- K133370 — REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE
- K140273 — EQUALIZER OCCLUSION BALLOON CATHETER
- K140456 — BIO-CONNEKT WOUND MATRIX
- K140487 — VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING
- K140864 — VELOXTM INTERBODY FUSION SYSTEM
- K140876 — VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCREW
- K141154 — OARTRAC SYSTEM
- K141583 — SHASER SKIN BEAUTY INTENSE PULSED LIGHT SYSTEM FAMILY
- K141652 — CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE
- K141663 — EEVA DISH (WITH 12 MICROWELLS)
- K141677 — VARIAX ELBOW PLATING SYSTEM
- K141678 — EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
- K133419 — BABYMEG BIOMAGNETOMETER SYSTEM
- K134031 — THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER
- K140726 — CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 5, CAPTIV
- K140879 — BIOSURE HEALICOIL PK INTERFERENCE SCREW
- K140915 — EXCIA TOTAL HIP SYSTEM
- K141034 — AZUL PERSONAL LUBRICANT
- K132732 — MEDYSSEY ANTERIOR CERVICAL FUSION CAGE
- K133233 — PJUR ORIGINAL, PJUR WOMAN, PJUR MAN EXTREME GLIDE
- K133551 — ZIMMER ZFX TITANIUM BASE ABUTMENT FOR TAPERED SCREWVENT IMPLANT SYSTEM
- K133699 — POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES
- K140005 — ALMA DIODE TABLETOP LASER
- K140082 — AEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEM
- K140200 — E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES
- K140518 — GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER
- K140845 — LEVO TINNITUS MASKING SOFTWARE DEVICE
- K140897 — SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL
- K141100 — OPTILITE C1 INACTIVATOR KIT
- K141118 — NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER
- K141219 — JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITS
- K141265 — ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT
- K141280 — ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS
- K141430 — VARIAX DISTAL RADIUS PLATING SYSTEM
- K141577 — ARTHREX PIP DART
- K141625 — POLYSYN SURGICAL SUTURE
- K141639 — VOLUSON S6, VOLUSON S8
- K141641 — ZONARE ZS3 DIAGNOSTIC ULTRASOUND SYSTEM
- K141654 — THE BELMONT RAPID INFUSER
- K131757 — TATTOOSTAR EFFECT COMBO
- K140499 — VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202 STERILIZATION PROCESSES
- K140504 — ACCUCATH BC INTRAVASCULAR CATHETER SYSTEM
- K140515 — VERIFY HPU CHEMICAL INDICATOR/ VERIFY VAPORIZED VH202 PROCESS INDICATOR ADHESIVE LABEL
- K140682 — FINGERTIP PULSE OXIMETER
- K140750 — SHILLA GROWTH GUIDANCE SYSTEM
- K140757 — D2 HEMOSTANTIC DRESSING
- K140825 — DELWORKS DR SYSTEM
- K140903 — NUVIS ARTHROSCOPE
- K141143 — COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET
- K141647 — HEALGEN COC ONE STEP COCAINE TEST STRIP:MORHPINE TEST STRIP (CASSETTE, CUP, DIP CARD)
- K133568 — G-TL
- K140142 — CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON)
- K140558 — PROCTIGARD
- K140714 — PORCINE ANORGANIC BONE MINERAL
- K140844 — BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC
- K141000 — SENSITITRE SUSCEPTIBILITY PLATES
- K141112 — STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER
- K141217 — ACCULIF TL AND PL CAGE
- K141563 — SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC
- K141566 — SOLID STATE X-RAY IMAGING DEVICE, DIGIITAL FLAT PANEL X-RAY DETECTOR, 1417WCC
- K132856 — HEARTWAY POWER WHEELCHAIR
- K133053 — MILESTONE SPINAL SYSTEM
- K133813 — FLXFIT INTERVERTEBRAL BODY FUSION DEVICE
- K133890 — AESCULAP OPTILENE NONABSORBABLE SUTURE
- K140615 — VICTUS FEMTOSECOND LASER PLATFORM
- K140753 — ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM
- K140789 — CORMATRIX ECM FOR VASCULAR REPAIR
- K140813 — REPROCESSED KENDALL SCD EXPRESS COMPRESSION SLEEVES
- K140826 — GMK SPHERE EXTENSION
- K141063 — LINSCAN 808, LINSCAN 980
- K141609 — PULSTAR LOGIX PUMP
- K132765 — PFX SPINOUS PROCESS FIXATION SYSTEM
- K133919 — CONSENSUS VITALITE TIBIAL INSERT
- K140829 — UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT
- K141532 — CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE
- K141605 — CD HORIZON SPINAL SYSTEM
- K131094 — VIMOVE
- K131513 — SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY
- K132806 — FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECE
- K133676 — ABX PENTRA MICRO ALB CONTROL L/H
- K140186 — THE STORK OTC
Data sourced from openFDA. This site is unofficial and independent of the FDA.