FDA 510(k) clearances — page 856
clearances on record, most recent first.
Clearances — page 856
85,501–85,600 of 176,637- K993618 — DXP1000 HOLTER RECORDER
- K993637 — N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS
- K993648 — ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER
- K993791 — CT PERFUSION OPTION
- K993792 — SMART VESSEL ANALYSIS (SMART VA) OPTION
- K972383 — EASY-JET DEVICE
- K983198 — TRENDCARE CALIBRATOR MODEL SCU 7007
- K990512 — STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS
- K991473 — SIRSCAN
- K991906 — LAPARO CO2-PNEU AUTOMATIC INSUFFLATOR WITH 30L FLOW RATE,AND VIDEO-SCREEN DISPLAY, HIGH FLOW INSUFFLATION TUBE WITH HEAT
- K992235 — ZYRANOX ZIRCONIA CERAMIC FEMORAL HEADS
- K992330 — THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
- K992341 — CIDEX OPA SOLUTION TEST STRIP
- K992538 — AMORPHOUS DIAMOND COATED SCREW
- K992890 — ROCHE COBAS INTEGRA OPIATES 300/2000
- K992920 — EBI SPINELINK SYSTEM
- K992925 — AX WORKSTATION DR-VIEWER SOFTWARE OPTION
- K992994 — TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS
- K993119 — STERILE HYDROGEL
- K993128 — HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER]
- K993213 — K-ASSAY IGA
- K993273 — N LATEX FERRITIN
- K993286 — PIONEER SILICOAT STERNAL CABLE
- K993313 — COMFIT POWDER FREE BLUE NITRILE EXAMINATION GLOVE, STERILE
- K993349 — NIL, SURGEON'S GLOVE - POWDER FREE
- K993722 — BLUE CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS.
- K993723 — CARDIASURE CARDIAC MARKERS CONTROL
- K993725 — GREEN CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS
- K992125 — XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46
- K992239 — PILLAR CHIN IMPLANT
- K992240 — PILLAR MALAR IMPLANT
- K992242 — PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS
- K992829 — CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3
- K992852 — SUTURE CLINCH
- K992887 — STAK-CHEX PLUS RETICS
- K993046 — FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000
- K993501 — 3D1 MICROPOSITIONING HEADSTAGE
- K993540 — ENDOSPINE OPERATING TUBE AND TELESCOPE BRIDGE
- K993666 — DISETRONIC PEN P100
- K990292 — I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN
- K990537 — OSTEO-PIN MEMBRANE FIXATION PIN
- K992832 — SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS
- K992848 — ALARMVIEW SYSTEM
- K992881 — HI BOND NON-PRECIOUS CERAMIC ALLOY
- K992885 — VERSALOK LOW BACK FIXATION SYSTEM
- K992919 — OXY-GLIDE ROOT CANAL CLEANSER & LUB.
- K992952 — LORENZ DISTRACTION SYSTEM
- K992964 — IBC VENT VALVE, MODEL 1400
- K993049 — DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES
- K993061 — STRYKER LEIBINGER RESORBABLE FIXATION SYSTEM
- K993082 — EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR COMPONENT
- K993183 — POWDER FREE GLOVES (POLYMER COATED)
- K993311 — COMFIT POWDER FREE NITRILE EXAMINATION GLOVE, STERILE
- K993347 — NIL, NITRILE EXAMINATION GLOVE - POWDERED
- K993348 — NIL, NITRILE EXAMINATION GLOVE - POWDER FREE
- K993352 — CROSSFIRE SYSTEM 12 ACETABULAR INSERTS
- K993419 — OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE; POLYMER COATED WITH PROTEIN CLAIM (50 MICROGRAMS OR LESS)
- K993479 — OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (100 MICROGRAMS OR LESS)
- K993555 — MASIMO SET/QUARTZ 2500 PULSE OXIMETER AND ACCESSORIES
- K993603 — WICHITA FUSION NAIL FULLY THREADED SELF-TAPPING SCREW
- K993649 — EBI XFIX DFS WRISTFIX SYSTEM
- K993823 — MED-4000
- K983239 — WATER PURIFICATION COMPONENTS AND SYSTEMS HEMODIALYSIS
- K983753 — STAR TEMPORARY WOUND COVER
- K984219 — COLORMAX COLOR VISION ENHANCEMENT LENSES
- K990177 — NELLCOR PURITAN BENNETT ACHIEVA VENTILATOR AND REPORT GENERATOR
- K990290 — CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER
- K990475 — TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5
- K991286 — AVOCET ACUSURE SYSTEM
- K991786 — MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION
- K992510 — WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
- K992697 — PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM
- K992813 — 11 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GAUGE PROBE, ULTRASOUND, HOUSING STEREOTACTIC,HOUSING, ULT
- K992866 — OPTILITE IX LASER SURGERY ACCESSORIES
- K992874 — Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM
- K992915 — ONE-STEP DOUBLE-CHEK PREGNANCY TEST
- K992945 — RCI FIXATION SCREWS (WITH ASSORTED SIZES)
- K992950 — CUSTOM PROSTHETIC (HEFILCON A) SOFT LENS
- K993160 — OMEGA TRAC, MODEL Z100
- K993285 — AURORA SL
- K993581 — HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER
- K990779 — HEMASEAL & CIDE
- K991993 — PHACOLASE ER: YAG LASER
- K992678 — PATIENT NITRILE EXAMINATION GLOVES POWDER FREE CHLORINATED
- K992822 — SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE
- K992824 — LASEREX ND:YAG OPHTHALMIC LASER (LQ2106), ALCON ND:YAG OPHTHALMIC LASER (3000LE), LASEREX ND:YAG OPHTHALMIC LASER, MODEL
- K992931 — NON-STICK BIPOLAR FORCEPS
- K993120 — MODIFIED BLOOD RECIPIENT SET
- K993133 — CASHMERE NON-STERILE POWDERED NITRILE EXAMINATION GLOVES BLUE AND GREEN
- K993134 — CASHMERE NON-STERILE BLUE POWDERED NITRILE EXAMINATION GLOVESBLUE AND GREEN)
- K993251 — IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6
- K993326 — NON-STERILE POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (70 MICROGRAMS OR LESS PER
- K993588 — MODIFICATION TO RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13,
- K993669 — LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
- K991024 — BONE BULLET SUTURE ANCHOR
- K991059 — SPECTRANETICS 0.014 SUPPORT CATHETER, MODEL 518-016, SPECTRANETICS 0.018 SUPPORT CATHETER, MODEL 518-017
- K992287 — FIRST STEP UNICOMPARTMENTAL KNEE SYSTEM
- K992776 — UNI-GRAFT K DV PATCH
- K992792 — XIA SPINAL SYSTEM C-C ADAPTOR
- K992793 — SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.