FDA 510(k) clearances — page 849
clearances on record, most recent first.
Clearances — page 849
84,801–84,900 of 175,890- 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
- K992978 — RICROKERATOME BLADE
- K992993 — ETEST FOR QUINUPRISTIN/DALFOPRISTIN
- K993067 — SILHOUETTE SPINAL FIXATION SYSTEM
- K993177 — SABRE
- K993298 — E Z CHAIR
- K993510 — MODIFIED BMP TROCHANTERIC PLATES
- K993601 — HOWMEDICA OSTEONICS FEMORAL HEADS
- K993640 — SPECTRUM LIBRE WHEELCHAIR
- K993647 — UNIMED DISPOSABLE HAND AND FOOT-SWITCHING PENCILS WITH HOLSTER AND 1BLADE AND TIP CLEANER, UNIMED DISPOSABLE HAND AND F
- K993670 — MODIFIED LONG LENGTH GAMMA NAIL
- K993715 — QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3
- K992838 — ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE
- K993012 — MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311
- K993344 — P10 SPECIAL
- K990927 — SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER
- K991315 — MICROALBUSTIX REAGENT STRIPS (OTC)
- K992770 — QUALITROL IMMUNOLOGY CONTROL, LEVEL 1, 2 AND 3
- K992777 — CONSTELLATION CATHETERS, MODEL 8039
- K992790 — BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG
- K992791 — BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO
- K992863 — LEAD STYLET,MODELS 6505,6506,6507,6508
- K992921 — PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II
- K993086 — AUTOSTAT II ANTI-GLIADIN IGA ELISA
- K993087 — AUTOSTAT II ANTI-GLIADIN IGG ELISA
- K993108 — VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96
- K993109 — VARELISA RECOMBI ANA PROFILE
- K993162 — WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR
- K993250 — THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM.
- K993254 — IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06
- K993321 — R&D HGB/GLC WHOLE BLOOD CONTROL
- K993558 — EZFLOW MAX, MODEL 1007
- K993620 — IMPRESARIO
- K993632 — FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
- K993665 — LEGEND CRF FLUORO AND RAD SYSTEM
- K991052 — FS 1000 KNEE SYSTEM
- K991320 — MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN
- K991561 — ROADRUNNER, PEP THERAPY DEVICE
- K992234 — THE TAPER-FIT TOTAL HIP SYSTEM
- K992505 — TERATECH, MODEL 2000 IMAGING IMAGING
- K992713 — POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101
- K992722 — PRIMEAIRE
- K992731 — E.CAM COMPUTER
- K992733 — AKRON ATP9 TRACTION MACHINE
- K992833 — VACUUM ASSIST STABILIZER
- K992857 — LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070
- K992906 — COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT
- K992969 — RESPIRONICS TOTAL FACE MASK
Data sourced from openFDA. This site is unofficial and independent of the FDA.