FDA 510(k) clearances — page 681
clearances on record, most recent first.
Clearances — page 681
68,001–68,100 of 175,825- K041613 — NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE
- K041616 — BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID
- K041720 — VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II
- K041799 — VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 17, VITROS CHEMISTRY PRODUCTS FS
- K041873 — AEQUALIS REVERSED SHOULDER PROSTHESIS
- K042023 — FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER
- K042025 — MODIFICATION TO CD HORIZON SPINAL SYSTEM
- K042066 — KLSA MARTIN HAND DISTRACTOR
- DEN040002 — NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970
- K032291 — TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM
- K033738 — MONITORING SYSTEM, MODEL ARGUS PB-2200
- K041169 — PIESOMETER, MODEL MK-1
- K041400 — FORTIFIER DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LF-01
- K041458 — MARE DENTAL OPERATIVE UNIT
- K041843 — PENCIL POINT NEEDLE
- K041845 — NEXUS PAV LUER LOCK DEVICE, MODEL NIS-4
- K041974 — MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER
- K042081 — PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
- K042138 — FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-311
- K032949 — SPOT CHECK PULSE OXIMETER,512/513
- K040368 — VECTORVISION HIP 3.0
- K041371 — BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN
- K041976 — SMITH & NEPHEW GRAFT DELIVERY SYSTEM
- K042036 — AIRGUARD VALVED INTRODUCER
- K042204 — MODIFICATION TO PROTEGE GPS SELF-EXPANDING NITINOL STENT
- K031813 — OSSATURA DENTAL
- K040996 — RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM
- K041003 — IMMUNOCARD TOXINS A & B, MODEL 712050
- K041276 — POWDER-FREE NITRILE EXAMINATION GLOVES
- K041359 — BODY CLOCK STIMPLUS AND STIMPLUS PRO
- K041409 — MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-230799
- K041436 — SYNTHETIC SURGICAL GLOVE-POWDERFREE NUZONE X2
- K041840 — MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEM
- K041848 — POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR
- K041876 — NOBELDIRECT OD IMPLANT
- K041945 — POWDER-FREE BLUE VINYL EXAM GLOVES
- K041981 — GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VASOVIEW 6 ACCESSORY PACK, MODEL VH-2004
- K040529 — COCOON HYGIENIST
- K040542 — SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW
- K040741 — ULTRASOUND LOCALIZATION SYSTEM ULS 0142
- K041433 — BRIGHT GOLD XH
- K041493 — CEMENTEK
- K041527 — AARHUS ANCHORAGE SYSTEM
- K041610 — MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207
- K041668 — OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT
- K041887 — SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS
- K041889 — TRI-OSTETIC
- K041995 — MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY
- K042080 — TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM
- K042098 — SENORX INTRODUCER
- K040490 — WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE
- K040799 — HOMMED GENESIS PATIENT MONITOR SYSTEM WITH OPTIONS
- K040922 — VENTURE WIRE CONTROL CATHETER
- K041643 — SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT
- K041687 — ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR
- K041932 — OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM
- K041933 — MICROSELECTRON PDR
- K042140 — OLYMPUS BF TYPE UC160-OL8
- K031152 — PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST)
- K040108 — OPUE-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN
- K040525 — SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000
- K041205 — EXPEDIUM ANTERIOR SPINE SYSTEM
- K041393 — FASSIER-DUVAL TELSCOPIC IM SYSTEM
- K041666 — DC-ACETA/SAL CONTROLS
- K041939 — BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC LATERAL SPACERS
- K031714 — INION TRINION BIODEGRADABLE MENISCUS SCREW
- K032742 — SILVER FOAM WOUND DRESSING
- K032975 — JMS BLOOD TUBING SETS
- K033707 — POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX
- K033918 — EBI LACTOSORB GRAFT CONTAINMENT SYSTEM
- K040819 — TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834
- K041194 — ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H
- K041447 — NUVASIVE ANTERIOR CERVICAL PLATE SYSTEM
- K041461 — KMI DISTAL VOLAR RADIUS PLATE SYSTEM
- K041604 — MACRO-MICRO DEPTH ELECTRODE
- K041635 — G5 I HBA1C TEST, G5 II HBA1C TEST
- K041650 — MICRO PRIME
- K041782 — SEEMOR 5.0 IMAGE DISPLAY PROGRAM
- K041871 — INTERLAB MICROCAL SERUM CONTROLS
- K041878 — N LATEX CYSTATIN
- K041898 — CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM
- K041935 — DR SYSTEMS PACS, RELEASE 6.1
- K041946 — ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE
- K041947 — I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND
- K041973 — MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
- K041993 — 2 CM PERIPHERAL CUTTING BALOON
- K041998 — PHACO CHOP NEEDLES
- K042055 — CYPRESS ULTRASOUND SYSTEM
- K042103 — NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL
- K041262 — DURALITE-GL
- K041445 — IMMUNOCARD STAT! RSV MODEL #750630
- K042044 — ACUSON CV70 CARDIOVASCULAR SYSTEM
- K042124 — DENFIL
- K032192 — PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V
- K033027 — SHINMED VARIOUS MODELS OF ELECTRO-SURGICAL PENCILS, SW12200, SW12202, SW12300
- K033843 — SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING
- K040307 — HANSON SCAR ADE
- K040314 — HEALICOLL
- K040717 — NUNC IVF MULTIDISH 4 WELLS NUNCLON
- K040792 — POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE)
Data sourced from openFDA. This site is unofficial and independent of the FDA.