FDA 510(k) clearances — page 641
clearances on record, most recent first.
Clearances — page 641
64,001–64,100 of 176,637- K053595 — CURAY CUSTOM SEED ARRAY
- K053609 — PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
- K060033 — PROFILE MULTI-PLATFORM SYSTEM
- K060034 — NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE
- K060279 — CRYOCARE CS SURGICAL SYSTEM
- K060400 — CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 68000; CARDIOBLATE BP2 SURGICAL ABLATION DEVICE, MODEL 60831
- K050586 — LEONE IMPLANT SYSTEM
- K052665 — GRANTON MEDICAL 121-135 C SELF-SEAL STERILIZATION POUCHES
- K053088 — SLACTIVE IMPLANTS
- K053182 — DRLOCK DISTAL RADIUS VOLAR SYSTEM
- K053340 — TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS
- K053605 — AEROECLIPSE II BREATH ACTUATED NEBULIZER
- K060011 — MIIG SR
- K060046 — DERMASTREAM
- K060090 — DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE
- K060097 — GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00
- K060256 — UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
- K060290 — SHOULDER FIXATION SYSTEM
- K060291 — PREFORMANCE TEMPORARY CYLINDER
- K060348 — MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
- K051020 — ES-160
- K051097 — GERATHERM SOS-RESCUE BLANKET
- K051137 — TECHDEVICE OCCLUSION BALLOON CATHETER
- K052241 — DISC-FX SYSTEM
- K052732 — ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P
- K053223 — TRITON/TRU-TRAC/TX/TRITON DTS TRACTION
- K053277 — CPS DIRECT SL OUTER CATHETER
- K053504 — MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.12-16 UG/ML)
- K060049 — REPROCESSED COMPRESSION SLEEVES
- K060268 — PEDIATRIC URINARY CATHETER
- K060335 — FILE-EZE
- K060350 — CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM
- K060395 — CRYO, MODEL V6.0
- K050757 — FLEX-AID LIQUID GEL BANDAGE AND DERMAFLEX GEL TISSUE ADHESIVE PROFESSIONAL LIQUID BANDAGE
- K052448 — POCKET BREATHALYZER. CONNECTABLES
- K052617 — FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H,
- K053344 — BIORAPTOR SUTURE ANCHOR, TWINFIX 2.8 MM SUTURE ANCHOR, TWINFIX 3.5 MM SUTURE ANCHOR
- K053364 — HALUX IRIS EXAMINATION AND SURGICAL LAMP
- K053378 — LOOP RECORDER VITAPHONE, 3100 SERIES
- K053412 — FLEXISCOPE, MODELS 50MH AND 50 MHC
- K053561 — BIO-MINI REVO SUTURE ANCHOR
- K060017 — MAKO SURGICAL UNICONDYLAR KNEE SYSTEM
- K060150 — SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM
- K060253 — STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST.
- K060334 — GI DENTSTAT
- K050783 — ISSYS DRUG FLOW MONITOR
- K053050 — PROCERA BRIDGE ALUMINA
- K053068 — PROCERA BRIDGE LAMINATE, MODEL 40-4002
- K053125 — PROCERA BRIDGE ZIRCONIA
- K053260 — OSSIX -PLUS
- K053424 — POPMESH
- K053484 — INFINITY GAMMA / GAMMAXL, INFINITY VISTA
- K053493 — BERRY FRUITY TEETHER
- K053604 — WAVELIGHT IDAS
- K053625 — NASALGUARD
- K060004 — CALDERA MESH
- K060113 — DERMACYN WOUND CARE
- K060117 — BOVIE BUTTON REMOTE HAND SWITCH
- K060259 — DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 2121
- K060283 — TRANSET SYSTEM
- K051244 — GENZYME OSOM INFLUENZA A & B TEST
- K052705 — DART-12
- K052823 — IMPLANTIUM ABUTMENTS
- K053367 — MALE NATURAL RUBBER LATEX CONDOM
- K053374 — OSSAPLAST DENTAL (PARTICLE SIZE OF 500 TO 1000 UM TO 2000 UM)
- K053635 — MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
- K060162 — ACL ELITE; ACL ELITE PRO
- K050086 — BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING
- K051175 — CIV-OB OBSTRICAL MONITORING SOFTWARE APPLICATION
- K051525 — ARX SPINAL SYSTEM
- K051636 — CAMLOG DENTAL IMPLANT ABUTMENTS, HEALING CAPS, AND ACCESSORIES
- K051931 — AXCEL
- K052057 — LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
- K052089 — XR-SERIES BI-METRIC FEMORAL COMPONENTS
- K052347 — TITAN STEERABLE (PTCA) GUIDEWIRE
- K052659 — SPIDERX EMBOLIC PROTECTION DEVICE
- K052676 — KD-322 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
- K052828 — DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT)
- K053148 — CXR16
- K053253 — HEMOCUE ALBUMIN 201 ANALYZING SYSTEM
- K053318 — RX EPIDURAL NEEDLE
- K053397 — K-Y BRAND SENSUAL MIST
- K053558 — CEPH, MODEL 4900
- K053581 — NUVASIVE SMARTPLATE GRADIENT PLUS SYSTEM
- K060019 — ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM)
- K060091 — ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVES
- K060174 — SPECTRUM FIVE LUMEN CENTRAL VENOUS CATHETER SET, MODEL C-UQLM10.0-ABRM
- K060221 — THE PHILLIPS, MODEL MP20,MP30,MP40,MP50,MP60,MP70,MP80,AND MP90 INTELLIVUE PATIENT MONITORS
- K060293 — TEMPORARY CROWN AND BRIDGE MATERIAL
- K050956 — TBR IDEA CONIC/CONIC
- K051489 — EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM
- K052168 — MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC.
- K053108 — DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108
- K053139 — FOTONA QX ND:YAG/KTP LASER SYSTEM
- K053183 — JIVE X SOFTWARE
- K053293 — ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS
- K053376 — CHUNG CHENG FAR INFRARED RAY HEALTHFUL LAMP (OR MEDICAL FIR RADIATOR), MODEL CH-8810
- K053512 — HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310
- K060108 — COBAS INTEGRA CHLORIDE ELCTRODE GEN.2
- K060133 — ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET
Data sourced from openFDA. This site is unofficial and independent of the FDA.