FDA 510(k) clearances — page 589
clearances on record, most recent first.
Clearances — page 589
58,801–58,900 of 176,637- K072422 — CYBERWAND STERILE PADS, MODEL: CW-RBPBX
- K072706 — MICROCHOICE DRILLS AND SAWS, MICROPOWER DRILLS AND SAWS, MICROPOWER ORALMAX HIGH SPEED DRILL
- K072826 — APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM
- K070520 — PRO QR (QUICK RELIEF) POWDER (FOR MINOR EXTERNAL BLEEDING FROM WOUNDS & PROCEDURES)
- K070865 — EXPANDING VASCULAR SHEATH
- K071046 — SYNTHES CHRONOS COMPOSITE
- K071070 — OLYMPUS DENTAL IMPLANT SYSTEM
- K071271 — BIOMET CABLE SYSTEM
- K071726 — ZUMA
- K071833 — MOSAIC DEVICES
- K072362 — NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG
- K072519 — ACTIVATOR V SPINAL ADJUSTING INSTRUMENT
- K072636 — A-BSM BONE SUBSTITUTE MATERIAL
- K072655 — ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR
- K072705 — ASAHI PTCA GUIDE WIRE, FIELDER FC J, MODELS: AGP140001J, AGP140301J
- K072768 — RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS
- K072824 — FOX SV PTA CATHETER
- K072865 — MODIFICATON TO: ARTHROCARE ARTHROWANDS
- K070484 — QUANTRX FEMALE FERTILITY TEST
- K071899 — BIS MODULE FOR ENVOY PATIENT MONITOR
- K071931 — CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223
- K072045 — ONCONTROL BONE MARROW BIOPSY SYSTEM
- K062932 — AHLSTROM GRADE 226 SPECIMEN COLLECTION PAPER
- K071617 — ORAL NEUTRALIZER
- K071796 — CAPSEW PLICATION SYSTEM
- K071838 — NEOSS VARIOUS TITANIUM ABUTMENTS
- K071937 — BONALIVE GRANULES AND BONALIVE PLATES
- K071986 — LTM-RC SURGICAL MESH
- K072016 — CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE
- K072235 — PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR
- K072339 — NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM
- K072402 — FLEX-STAR V
- K072426 — ATLAS SPINE PEDICLE SCREW SYSTEM
- K072488 — LANFAN POWDER-FREE VINYL EXAM GLOVES
- K072638 — ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801
- K072685 — NGARDE SYSTEM
- K072789 — DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES
- K070530 — MODIFICATION TO PASSMED SPINAL SYSTEM
- K070930 — REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS
- K071013 — REDSENSE
- K071101 — TRU RSV
- K071194 — RAPHAEL COLOR ASV VENTILATOR
- K071632 — PERFECT TISSUE CONTOURING SYSTEM II
- K071851 — HDC STERILE SPIDER SCREW
- K071909 — PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R
- K071948 — AEQUALIS REVERSED ADAPTER
- K072011 — COPD LIQUID OXYGEN PORTABLE, MODEL 300P
- K072020 — RESTORATION ADM SYSTEM
- K072050 — PROLONG-EX, MODELS: PLEX-50CS, PLEX-100CS, PLEX-150CS
- K072125 — ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT
- K072255 — MINRAD INC. NASAL SCAVENGING CIRCUIT
- K072397 — SYNOSS SYNTHETIC BONE GRAFT MATERIAL
- K072516 — MIDMARK DIAGNOSTICS IQMARK VITAL SIGNS MONITOR
- K072574 — ALPHARD CONE BEAM CT, MODEL X178
- K072735 — PULSION PICCO-2, MODEL 8500
- K063145 — PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS
- K070405 — MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT
- K070438 — MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305
- K071993 — T-PORT HP INFUSION PORT
- K072046 — EXACTRAC 3RD PARTY, EXACTRAC X-RAY 6D 3RD PARTY, EXACTRAC OEM
- K072365 — SEQUOIA PLUS DIAGNOSTIC ULTRASOUND SYSTEM
- K072435 — DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H
- K072797 — GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND
- K071049 — DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR
- K071087 — VIS-U-ALL II HEAT-SEAL POUCH AND TUBING
- K071382 — SCM CATH ( SIZES ARE VARYING BETWEEN 16G X 2'' AND 24G X 3/4'' ), MODEL 1.50, 1.77,1.88',2, 1.25, 1.50, 1.77,
- K071814 — LIGHT SABRE SPINAL ACCESS DEVICE
- K072035 — RESOLVE UVB PHOTOTHERAPY SYSTEM
- K072454 — INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS
- K072474 — QUIKCLOT EX
- K072715 — REALHAND HIGH DEXTERITY INSTRUMENTS
- K072841 — NEUVIZ SPIRAL CT SCANNER SYSTEM
- K062447 — TRAVERSE OCT SPINAL FIXATION SYSTEM
- K063788 — REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS
- K070195 — BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B
- K070751 — ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY
- K071100 — AMNISCREEN HOME DETECTION LINER KIT
- K071593 — PTS PANELS CHOL+HDL PANEL TEST STRIPS
- K071888 — STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGES
- K072029 — PHENIX VERTEBRAL BODY REPLACEMENT
- K072221 — MODIFICATION TO TRIATHLON TS KNEE SYSTEM
- K072401 — DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR
- K072597 — PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT
- K072668 — VITEK 2 GRAM POSITIVE VANCOMYCIN
- K072675 — SMITH & NEPHEW ARTHROSCOPE
- K072767 — QUASAR BLUE LIGHT THERAPY SYSTEM
- K063295 — ACON UTI URINARY TRACT INFECTION TEST STRIPS
- K070146 — ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP
- K070212 — CITOP10 GUIDEWIRE, 0.014(1.4MM TIP), CITOP6 GUIDEWIRE, 0.014(1.0MM TIP), CITOP SUPPORT ACCESSORY, 0.023(126CM)
- K070414 — GAMBRO CARTRIDGE BLOOD SETS
- K070601 — MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM
- K070765 — VIS-U-ALL II SELF SEAL POUCH
- K070845 — SOUNMED COLOPOSCOPE COLPO-99/99PLUS
- K070955 — ACID ETCHED LAG SCREWS
- K071561 — HI-SPEED TURBINE HANDPIECES, MODEL GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-D
- K071713 — CLARIAN GLUCOSE STABILIZER INSULIN DOSING CALCULATOR
- K071914 — MERCURY SPINAL SYSTEM
- K071947 — VACU-MED BLOOD COLLECTION NEEDLES
- K072187 — PIONEER LOWTOP SPINAL ROD SYSTEM
- K072225 — ANGIOSCULPT PTA SCORING BALLOON CATHETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.