FDA 510(k) clearances — page 705
clearances on record, most recent first.
Clearances — page 705
70,401–70,500 of 176,637- K040508 — VITALAB MAGNESIUM REAGENT
- K020895 — ALLOMATRIX MODEL# 86
- K031511 — DYNESYS SPINAL SYSTEM
- K032278 — AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE
- K032688 — COLONOSIGHT MODEL 510B
- K033136 — I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2
- K033249 — PAJUNK MODULAR HANDLE INSTRUMENTS
- K033410 — TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002
- K033810 — NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM
- K034014 — SPI CONTACT DENTAL IMPLANT
- K034029 — TI CLIP APPLIER
- K040095 — IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA
- K040198 — LABONE COCAINE METABOLITE MICRO-PLATE EIA
- K040260 — INTEGRAL HEMODIALYSIS CATHETER
- K040288 — QSC-127-INT SHOULDER ARRAY COIL SET
- K040405 — CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY
- K040436 — SIMIDUR SUPERIOR
- K040446 — ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
- K040455 — LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS
- K031100 — SYNTHES VENTROFIX MIS SYSTEM
- K032454 — SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM)
- K032516 — HIOX80 AEROSOL ADAPTER
- K032834 — BIPAP PRO 2 BI-LEVEL SYSTEM
- K033060 — CALIBRATING MATERIAL, CALIBRATING STANDARDS
- K033301 — IV ADMINISTRATION AND CONNECT SETS
- K033842 — NUBERT, ALBERT AND HUBERT IMPERVIOUS BAGS FOR ENDOSCOPIC RETRIEVAL OF TISSUE
- K033947 — SHIRAZ POSTERIOR SYSTEM
- K033965 — SHIRAZ-ANTERIOR SYSTEM
- K040180 — CONTINUM V
- K040200 — MESACUP-2 TEST CENP-B
- K040273 — LYPHOCHEK ASSAYED CHEMISTRY CONTROL
- K040366 — PRESSURE MANIFOLD, MODEL BC 110
- K040507 — TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000H
- K031114 — PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA
- K031903 — RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568
- K031930 — HIGH SPEED EMG MODULE
- K031935 — TIARA MEDICAL SYSTEMS ADVANTAGE II NASAL MASK, MODELS TMS-2520 AND TMS-2530
- K032733 — PM-8000 PATIENT MONITOR, MODEL 8000
- K032840 — ATRION MEDICAL QL INFLATION DEVICE
- K033531 — POWDERED LATEX EXAMINATION GLOVES
- K033980 — BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION)
- K034004 — DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE
- K034066 — B.BRAUN PREMIXED DIALYSATE
- K040037 — MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
- K040043 — NDX-40 ALLOY
- K040179 — CONTINUM
- K040210 — CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR
- K040247 — PLUME SAFETY AVF NEEDLE
- K040300 — STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)
- K040357 — M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A TELEMETRY MONITORING SYSTEM II
- K023342 — NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BG
- K032330 — CT OIA
- K033251 — THE FRIENDLYLIGHT ND: YAG LASERS
- K033555 — KENKOWAVE INFRARED PAIN TREATMENT SYSTEM
- K033619 — NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000
- K033774 — CT-MASS
- K033816 — SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM
- K033851 — DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G)
- K033881 — MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE
- K033887 — NON-STERILE BLUE & WHITE COLOUR POWDER FREE BARRIER PRO POLYBUTADIENE COPOLYMER EXAMINATION GLOVES
- K040025 — A1C-CELLULAR
- K040279 — VIVARING MICROWAVE ABLATION PROBE
- K040345 — MODIFICATION TO NITREX NITINOL GUIDEWIRE
- K023684 — CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365
- K031961 — INION OTPS BIODEGRADABLE MESH PLATING SYSTEM
- K032610 — MODIFIED SONAMET BODY COMPOSITION ANALYZER
- K032675 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFEPIME (GN) 0.5-65 UG/ML
- K032986 — CLO-SURPLUSP.A.D.
- K033150 — ART POSTERIOR SPINAL SYSTEM
- K033378 — VITAL SIGNS MONITOR, PROPAQ LT
- K033616 — TRAPMATIC SYSTEM SET
- K033617 — EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY
- K033764 — SP NEWTRON MODULE
- K033783 — IMALUX OCT IMAGING SYSTEM
- K033792 — BILOK ST SCREW
- K033814 — BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007
- K033948 — MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN)
- K033975 — SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS
- K033995 — 3.5 MM LCP DISTAL HUMERUS SYSTEM
- K034049 — HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM
- K040023 — CAPIOX FLEXIBLE VENOUS RESERVOIR
- K040100 — ARROW ECHOGENIC INTRODUCER NEEDLE
- K040232 — LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999
- K040278 — PERIOGLAS-BIOGLASS BONE GRAFT SUBSTITUTE
- K040304 — PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP40 & MP50
- K040338 — ARTHROCARE CONTROLLER, CABLE, FOOT CONTROL, POWER CORD, WANDS, MODELS H0970-02, H2000-04, H2000-05, H0970-06
- K040356 — KOMPRESSOR SCREW SYSTEM
- K040372 — LIGHTSPEED 7.0 CT SCANNER SYSTEM
- K020078 — EXACTECH RESORBABLE BONE PASTE
- K032421 — AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE
- K032843 — NEXIVA CLOSED IV CATHETER SYSTEM
- K033278 — RANDOX URIC ACID
- K033330 — CONDUCTIVITY/TDS CALIBRATOR SOLUTION
- K033697 — POWER LED
- K033728 — TRANSVAGINAL ENDOSCOPY SET
- K033771 — BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR
- K033786 — LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVA
- K033802 — ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM
- K033879 — VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126
- K034027 — KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.