FDA 510(k) clearances — page 857
clearances on record, most recent first.
Clearances — page 857
85,601–85,700 of 176,637- 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
- K993021 — METRX SYSTEM
- K993167 — MILLENNIUM INFANT VENTILATOR
- K993234 — MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
- K993385 — AUTOJET 2 (NON-FIXED NEEDLE TYPE)
- K993434 — PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
- K993458 — POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM)
- K993488 — LIGHT-CORE
- K993583 — ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM
- K993624 — SITE-RITE 3 ULTRASOUND SYSTEM
- K990457 — TED 60T OXYGEN ANALYZER
- K991880 — LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY
- K991907 — ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
- K992136 — BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS)
- K992709 — 1818 TENS UNIT
- K992740 — EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS
- K992741 — LYPHOCHEK ANEMIA CONTROL, MODEL 500
- K992746 — SIGNA HFO/I MAGNETIC RESONANCE SYSTEM
- K992794 — STINGRAY DR, MODEL 1
- K992836 — SL990, SL980, SL950
- K992875 — SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER
- K992879 — ECUSIT COMPOSITE REPAIR
- K992886 — POWERVIEW ULTRASOUND WORKSTATION, UIDM-400A
- K992997 — OSTEOMARK NTX POC
- K993022 — SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS
- K993050 — OMNI GRACE NITRILE, GREEN, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
- K993161 — COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM
- K993174 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
- K993219 — WAKO BILIRUBIN CALIBRATOR
- K993281 — K-ASSAY IGG
- K993324 — CARBOCEM ZINC POLYCARBOXYLATE CEMENT
- K993453 — MENISCUS ARROW, MODELS 531110, 531113, 531116
- K993466 — WAKO L-TYPE TRIGLYCERIDE TEST
- K993469 — WAKO L-TYPE UA F TEST
- K993712 — BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
- K991326 — ISOBAR SEMI-RIGID SPINAL SYSTEM
- K991662 — TITANIUM HARTSHILL SYSTEM
- K992621 — ADI 9000/9001 ARTHROSCOPE AND ACCESSORIES
- K992674 — HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A
- K992702 — EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM
- K992738 — ISOBAR SPINAL SYSTEM
- K992961 — LORENZ SMALL FRAGMENT SYSTEM
- K992970 — DIGIT WIDGET
- K993141 — AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015
- K993146 — DORNIER SCANNER HANDPIECE
- K993242 — CASTLE SURGICAL LIGHT, MODEL 3000
- K993516 — HP M2600A VIRIDIA TELEMETRY SYSTEM
- K990103 — MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE
- K990546 — DELSONIC 2000
- K991344 — WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS
- K991486 — ULTRA-CBX
- K992373 — ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLE
- K992654 — PLUG 'N VIEW 3D, VERSION 1.0
- K992656 — DEPUY TOTAL ELBOW SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.