FDA 510(k) clearances — page 382
clearances on record, most recent first.
Clearances — page 382
38,101–38,200 of 176,542- K132709 — VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER
- K132797 — L'DISQ
- K132912 — DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT
- K133311 — ENDOLED
- K133402 — K2M MODULAR HOOKS
- K140302 — OPTETRAK LOGIC POROUS FEMORAL COMPONENTS
- K140883 — VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT
- K141001 — ALPINE HIP STEM; ALPINE HA HIP STEM
- K141011 — G-FORCE GEN 2 SUTURE ANCHOR SYSTEM
- K141026 — LEADERFLEX
- K141130 — ENCOMPASS
- K141145 — LIBERTY PDX CYCLER
- K141254 — ELCAM STOPCOCKS AND MANIFOLDS
- K141484 — OPEN FMSEALER
- K141778 — QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
- K133840 — Kangli Locking Plate System
- K133947 — IRIX-A LUMBAR INTEGRATED FUSION SYSTEM
- K140431 — PEDILOC FRAGMENT SYSTEM
- K140500 — SKINTACT
- K141109 — APERIO EPATHOLOGY EIHC IVD SYSTEM
- K141119 — CAMERA ENABLED PROBE
- K141120 — ZIMMER ZFX TITANIUM ABUTMENT FOR STRAUMANN BONE LEVEL IMPLANT SYSTEM
- K141167 — VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY)
- K141749 — CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT
- K141797 — ALTEON 6.5MM BONE SCREWS
- K133077 — GENERICA MEDICAL ENTERNAL DELIVERY; PUMP BAG SET, PUMP SPIKE SET, GRAVITY BAG SET
- K133809 — OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE
- K140071 — HUMELOCK II CEMENTED SHOULDER SYSTEM
- K140313 — STOPSBLEEDING TOPICAL HEMOSTAT POWDER AND FOAM
- K140469 — MR SYRINGE DUAL PACK
- K140479 — COROENT XL-F SYSTEM
- K140921 — COROENT SMALL INTERBODY SYSTEM
- K141071 — KIMGUARD ONE-STEP STERILIZATION WRAP
- K141631 — AQUARIUS EXTENSION FEEDING SET
- K141728 — ACE CALIBRATOR
- K121119 — BNA ANALYSIS SYSTEM
- K131720 — HIVOX SELF ADHESIVE ELECTRODE GEL PADS
- K133444 — STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM
- K133466 — CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM)
- K133658 — CDI BLOOD PARAMETER MONITORING SYSTEM 500
- K134029 — BELTER BLOOD PRESSURE METER
- K140250 — 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE
- K140494 — V-PRO STERILIZATION TRAY/ STERILIZATION MAT
- K140553 — ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS
- K140635 — COCOON CONVECTIVE WARMING SYSTEM
- K140770 — MLX - MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEM
- K140777 — ZQUIET-SA
- K140846 — EDS COMBO-RINSE
- K141116 — LIAISON XL ANALYZER
- K141193 — MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0
- K141311 — 0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH; SP SYRINGE, SF SYRINGE
- K141359 — HARD PACK SYRINGE
- K141367 — LS SERIES LINEAR STAPLER AND RELOADS, CLC SERIES CURVED LINEAR CUTTER AND RELOADS, LC SERIES LINEAR CUTTER AND RELOADS
- K141675 — VOLUSON P6, VOLUSON P8
- K141736 — PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST
- K141838 — SOL PORTABLE DIODE LASER UNIT (WITH WIRELESS FOOT CONTROL)
- K131226 — NOVAPROBE LED LIGHT SOURCE
- K131926 — THERMOPULSE
- K132749 — NOBELPROCERA OVERDENTURE BAR
- K132907 — PLIF LITE AND TLIF LITE
- K133156 — ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY +1 more
- K133336 — PJUR(R) SILICONEGEL, PJUR(R) BASIC PERSONAL GLIDE, PJUR(R) LIGHT, PJUR(R) MED PREMIUM GLIDE
- K133670 — HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE
- K133683 — MICR02 OSA DEVICE
- K133906 — C-JAWS CERVICAL COMPRESSIVE STAPLE
- K140096 — HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE
- K140281 — FLEXI-LUME LED SYSTEM
- K140295 — GIS ENDOSCOPIC OPTICAL LENS
- K140498 — V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM
- K140523 — RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM
- K140890 — NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU)
- K141028 — COLONGLIDE LUBRICANT
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.