FDA 510(k) clearances — page 787
clearances on record, most recent first.
Clearances — page 787
78,601–78,700 of 176,637- K011852 — DIMENSION HAIC ASSAY, MODEL DF105
- K012544 — VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEM
- K012752 — WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE
- K012763 — SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
- K013278 — TINA-QUANT APOLIPOPROTEIN A-1 VER.2
- K013431 — PASS SPINAL SYSTEM
- K013463 — ARTHROCARE ARTHRO WANDS, ENETEC EVAC PLASMA WAND
- K013526 — CAPIOX RX HARDSHELL RESERVOIR
- K013544 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
- K013545 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
- K013608 — DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D
- K011536 — MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE
- K012738 — SYMPHONY GRAFT DELIVERY SYSTEM (GDS)
- K012739 — CONVERGE ACETABULAR SYSTEM
- K012746 — ICE BATON
- K012750 — ADC PEDIATRIC
- K012751 — HEALOS BONE GRAFT MATERIAL
- K012771 — TROCAR SLEEVE AND ACCESSORIES, MODELS 1287-XX-XX
- K012801 — N2000 BASE STATION, N2001 NURSE STATION
- K012812 — CAROTID GUIDING SHEATH
- K012823 — MODIFICATION TO HANDMASTER
- K012882 — BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060
- K013283 — RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16
- K013285 — RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15
- K013291 — ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)
- K013402 — VISULAS 532S
- K013403 — TRI-FIX SPINAL FIXATION SYSTEM
- K013470 — MODIFICATION TO M2376A DEVICELINK SYSTEM
- K013524 — TROCHANTERIC DYAX NAIL SYSTEM
- K011048 — BSM BONE SUBSTITUTE MATERIAL
- K012718 — MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.
- K012753 — SORING GMBH SONOCA 180/190
- K012815 — SAFESKIN HEALTHTOUCH POWDER-FREE EXAM GLOVE WITH VITAMIN E AND ALOE
- K013087 — SINGLE DOSE DISPENSING PIN, MODEL 2201
- K013097 — WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003
- K013102 — WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002
- K013133 — NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116
- K013170 — SCANTAC MEMBRANE OR SCANTAC STRIP
- K013207 — TINA-QUANT APOLIPOPROTEIN B VER.2
- K013362 — AUTOJECT 2
- K013399 — MODEL MES-9000/EMG SYSTEM
- K013603 — MODIFICATION TO:MICRO TOUCH (R) POWDER FREE LATEX SURGICAL GLOVES , MODEL STYLE 65
- K013604 — MODIFICATION TO: ULTRALON (R) POWDER FREE LATEX SURGICAL GLOVES
- K013633 — SSA-770A, APLIO ULTRASOUND SYSTEM
- K012619 — VT-1
- K012620 — SE-200
- K012630 — REPROCESSED LINVATEC ARTHROSCOPIC BURS
- K012639 — SE-300 VACUUM THERAPY SYSTEM
- K012647 — TONOPORT V
- K012662 — SE-100 VACUUM ERECTION DEVICE
- K012664 — ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT
- K012665 — ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT
- K012670 — BOSS 2000-3 VACUUM ERECTION DEVICE
- K012672 — BOSS-2000-2 VACUUM ERECTION DEVICE
- K012698 — VANGUARD REPROCESSED PHACOEMULSIFICATION
- K012824 — ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE
- K012951 — APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE
- K012962 — DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM
- K012964 — 56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM
- K013114 — BCS SYSTEM
- K013126 — N LP(A) STANDARD SY
- K013152 — ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS
- K013372 — CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
- K013393 — HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM; MODEL #CP-1H
- K013497 — FAS SET #4551
- K013548 — STANDARD IMAGING IVB 1000 WELL CHAMBER
- K013573 — CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257
- K010819 — 3CC NMT SAFETY SYRINGE
- K011196 — IQUANTIFY, VERSION 1.0
- K011709 — UNI-GOLD STREP A TEST KIT
- K011812 — SPECTRUM VENTRICULAR CATHETER
- K011994 — ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101
- K012326 — WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001
- K012579 — REPROCESSED PHACO TIPS
- K012624 — REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS
- K012652 — REPROCESSED DYONICS ARTHROSCOPIC BURS
- K012679 — REPROCESSED RF ARTHROSCOPY PROBES
- K012682 — REPROCESSED LASER PROBE
- K012720 — TULSA CONTRA ANGLES
- K012724 — SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273
- K012725 — TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGERIES
- K012844 — MAROSIS PACS
- K012885 — NEUROMOVE NM900
- K013073 — INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA AND SAF-T-INTIMA INTRAVASCULAR CATHETERS
- K013339 — PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS
- K013378 — EBI XFIX DFS SYSTEM
- K013394 — LIFTLOC SAFETY INFUSION SET
- K013561 — LIGHTSPEED 4.0 CT SCANNER SYSTEM
- K010989 — TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL, MODEL 8119, 8120, 8130, 8131
- K011070 — DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR
- K011174 — PARADIGM-FONTONA PEROVSKITE ND: YAP LASER SYSTEM AND ACCESSORIES
- K011652 — BODY FAT ANALYZER, MODEL HBF-306
- K012571 — REPROCESSED HARMONIC
- K012578 — REPROCESSED ENDOSCOPIC TROCAR
- K012598 — REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTS
- K012603 — REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS
- K012605 — REPROCESSED ATHROSCOPICS BURS
- K012611 — REPROCESSED DYONICS ARTHROSCOPIC SHAVERS
- K012613 — REPROCSSED LINVATEC SHAVERS
- K012635 — REPROCESSED STRYKER ARTHROSCOPIC SHAVERS
Data sourced from openFDA. This site is unofficial and independent of the FDA.