FDA 510(k) clearances — page 1003
clearances on record, most recent first.
Clearances — page 1003
100,201–100,300 of 176,637- K960165 — ALPHA-DENT COMPOSITE SURFACE SEALANT
- K960219 — PROLEX MESH
- K960270 — DENTALOGIC
- K960317 — LAURUS NEEDLE CORE BIOPSY SYSTEM
- K960340 — CONSENSUS APEX DOME HOLE PLUG
- K960480 — IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013
- K960547 — DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVE
- K960878 — MAHLER ABDOMINAL WALL ELEVATOR
- K924313 — DIGITAL CONDUCTANCE METER
- K943843 — VARICELISA, MODIFICATION
- K953673 — ECLIPSE PROBE COVER
- K953773 — 6.5 MHZ ENDORECTAL CONVEX ARRAY (10R) PROBE
- K954648 — FEMRX OPERASTAR SYSTEM
- K955748 — DOYLE EXTRACTOR
- K960203 — G.E. STERILE AMNIOCENTESIS TRAY
- K960469 — DETECT CYTOLOGY BRUSH II
- K943025 — FREEMAN/SAMUELSON TOTAL KNEE SYSTEM
- K951193 — CLINICAL VITAL SIGNS MONITOR, MODEL #52STP-E1
- K954952 — MEDRAD/HITACHI 1.5T QUAD C-SPINE SURFACE COIL
- K955339 — HYDROLOGY 5000
- K955680 — SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED
- K955720 — AMAX CS-190 COAGULATION ANALYZER SYSTEM
- K955730 — EBI ANTERIOR CERVICAL SPINE SYSTEM
- K955761 — TIBIA ORTHONAIL
- K955781 — ALBUMIN
- K955863 — ALLDRESS MULTI LAYERED WOUND DRESSING
- K955884 — COORDINATE REVISION KNEE SYSTEM
- K955927 — BRYAN POSTERIOR SPINAL FIXATOR (MODIFICATION)
- K955939 — CALCIUM REAGENT
- K955940 — TOTAL BILIRUBIN REAGENT
- K960038 — SPECTRUM DESIGNS SILICONE BLOCK
- K960154 — PSA CONTROLS
- K960349 — PERMARIDGE HYDROXYLAPATITE MATRIX
- K952095 — VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)
- K953392 — HC500 SERVO-CONTROLLED HEATED RESPIRATORY HUMIDIFIER (& ACCESSORIES)
- K954006 — YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY
- K954164 — HYSTEROSCOPE
- K954415 — PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
- K954556 — SURGICAL CAP
- K955338 — DRYTIME FOR POTTY TRAINING
- K955426 — STERITEC CROSS-CHECKS
- K955645 — CATH-GUIDE
- K955657 — NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE
- K955679 — RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY
- K955724 — KC 1A COAGULATION ANALYZER/SET
- K955785 — TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SET
- K955812 — SYSCON TURMOR MARKER CONTROL
- K955872 — VOLMED OPERATION DRAPE
- K955936 — TOTAL PROTEIN REAGENT
- K955937 — INORGANIC PHOSPHORUS REAGENT
- K955938 — CREATININE REAGENT
- K960027 — HIGH VOLUME I.V. & IRRIGATION TOWER
- K960052 — RESOUND PERSONAL HEARING SYSTEM BT2-ES, BT2-EV, & BT241
- K960081 — BATTERY POWERED ENDOSCCOPIC LIGHT SOURCE
- K960129 — SAS SALMONELLA O GROUP Y FACTOR 48 ANTISERUM
- K960130 — SAS SALMONELLA O GROUP Z FACTOR 50 ANTISERUM
- K960147 — SAS SALMONELLA 0 GROUP E FACTORS 1,3,10,15,19,34 ANTISERUM
- K960160 — SAS SALMONELLA 0 GROUP M FACTOR 28 ANTISERUM
- K960198 — DIGISCOPE RX-2
- K960242 — CPR EYE TRAY
- K960324 — HEMAGEN CRP 150 KIT (EIA METHOD)
- K960400 — DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS)
- K960461 — SAS SALMONELLA O GROUP R FACTOR 40 ANTISERUM
- K960573 — SUNGLASSES/EYEGLASS FRAMES
- K960580 — BEAUCOUP GENERAL PURPOSE DISINFECTANT
- K960582 — ASCEND GENERAL PURPOSE DISINFECTANT
- K960583 — MATAR GENERAL PURPOSE DISINFECTANT
- K960786 — FABRIS LAN SUNGLASSES
- K960797 — D & K SUNGLASSES
- K943014 — BALLOON ELECTROSURGICAL PROBES AND DEVICES
- K952321 — PORCINE FACTOR VIII; C REAGENT
- K952540 — SONOS IMAGING SYSTEM (2000/2500 & 1000/1500)
- K953598 — SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS
- K953750 — CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- K953854 — WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE
- K954597 — RIGHT ANGLE LASER FIBERS
- K954625 — PROTHROMBIN TIME TEST CARD
- K954696 — ROGOZINSKI THORACOLUMBAR SPINAL ROD
- K954977 — URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION)
- K955125 — LMI OCCLUSION CATHETER
- K955403 — OES LAPARO-THORACO VIDEOSCOPE TYPE V
- K955532 — DIASTAT VASCULAR ACCESS GRAFT
- K955637 — ESSENCE GUIDEWIRE
- K955735 — KC 4A MICRO COAGULATION ANALYZER SET/SYSTEM
- K955873 — ACS PHENYTOIN ASSAY
- K955886 — MEGA PTA BALLOON CATHETER
- K955928 — BARBITURATE EIA ESSAY (MODIFICATION)
- K955932 — EXAFLEX IMPRESSION MATERIAL (MODIFICATION)
- K960085 — ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS
- K960099 — PENROSE DRAIN MODELS 6001 - 6007
- K960120 — STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS
- K960220 — SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
- K960261 — PALLIKARIS BRUSH
- K960266 — SIREGRAPH CF
- K960569 — DISPOSABLE PATIENT RETURN ELECTRODE
- K960791 — KARL STORZ HUZLY HIGH-FREQUENCY CUTTING LOOPS
- K960793 — SYNERMED ENZYMATIC CO2 REAGENT KIT
- K932330 — TI-6AL-7NB URTN
- K945518 — P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT
- K953607 — TITANIUM LIMITED CONTACT DYNAMIC HIP SCREW PLATE (TILC-DHS)
Data sourced from openFDA. This site is unofficial and independent of the FDA.