FDA 510(k) clearances — page 1209
clearances on record, most recent first.
Clearances — page 1209
120,801–120,900 of 176,637- K911871 — CARDIODYNE KINETORR/PC BLOOD PRESSURE MONITORS
- K911926 — POLARIS, OPHTHALMOLOGY
- K912404 — TRANSESOPHAGEAL TRANSDUCER THERMAL SAFETY
- K912730 — ROCKET SURGICAL SKIN MARKING PEN
- K913119 — VARIAN C-SERIES CLINACS (CLINAC 2300C/D)
- K913131 — HUMAN BETA-2 MICROGLOBIN EN-RID KIT
- K913176 — DELPHIN II CENTRIFUGAL SYSTEM
- K913357 — ONE TOUCH(R) II HOSPITAL BLOOD GLUCOSE MONIT SYST
- K913533 — MODEL M1403A TELEMETRY MONITORING SYSTEMS (TMS)
- K913558 — RELIABLE CONE STYLE FACE MASK
- K913559 — OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR
- K913573 — SAFETY PLUS DENTAL INJECTION NEEDLE
- K913616 — LSF DIAGNOSTIC RELATED GROUP CEMENTED HIP
- K913653 — 3M ANTI-DSDNA FAST TEST
- K913685 — UNICATH EP.
- K913738 — IL TEST(TM) AMPHETAMINE
- K913742 — IL TEST(TM) OPIATE
- K913743 — IL TEST(TM) PHENCYCLIDINE
- K913776 — PATIENT EXAMINATION GLOVES
- K913835 — SNOWDEN-PENCER INSUFFLATOR TUBING SET
- K913938 — OPUS(R) LH TEST SYSTEM
- K914066 — ELECTROSURGICAL CUTTING/COAGULATION DEVICE/ACCESS
- K914100 — STETHOSCOPE
- K914200 — VASCUMAP MEDICAL AIR PLETHYSMOGRAPH
- K914339 — DENTOMAT 3 AMALGAMATORS
- K914472 — SPIKED WASHER
- K914568 — MODEL DLASER 1000 ND; YAG LASER SYSTEM
- K914609 — TRIGLYCERIDES REAGENT SET
- K914628 — PYNE/CHEMO-TOUCH, ULTRA-SHIELD, PYNE-STERIE, MODIF
- K913523 — AUTO. OSCILLOMETRIC DIGITAL BLOOD PRESS. MONITOR
- K896378 — LYME-CHECK(TM) TEST KIT
- K904619 — INFU.DISK
- K910017 — Q4500 STREE TEST MONITOR
- K910997 — DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON
- K911974 — PGK STEREOTACTIC DEVICE
- K912250 — ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODES
- K912477 — ITC COAXIAL ANGIOGRAPHIC CATH SET, MODIFICATION
- K912893 — ORTHOPANTOMOGRAPH 100
- K912909 — SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM
- K912969 — TORQUE FITTING
- K913041 — ANTI-DSDNA ANTIBODY TEST
- K913074 — 0.016 GUIDE WIRE FOR NEUROLOGICAL ENDOSCOPE
- K913098 — APIRATION BIOPSY SYRINGE GUN, CAT. CODE #54501
- K913174 — VARIAN CLINAC 600SR
- K913366 — IN-THE-EAR HEARING AIDS
- K913391 — TEGWIRE (TM)
- K913514 — ELECTROSURGICAL UNIT CABLE
- K913517 — ISOLATE INFUSION CATHETR SYSTEM
- K913577 — MILESTONE MS 325 RADIOGRAPHIC X-RAY GENERATOR
- K913589 — EARSCAN DSP-1 PURE TONE AUDIOMETER
- K913697 — AUTOMATIC CORNEAL SHAPER
- K913747 — STAYFREE(TM) MAXI-PAD
- K913764 — ABBOTT QUICKSTART MAGNESIUM TEST, ITEM #5A32
- K913786 — FLEXIFLO OVER-THE-GUIDEWIRE GAST KIT W/CR-BAR BUMP
- K913837 — MICROSCIS(TM) INTROCULAR SCISSOR SYSTEM
- K914165 — X-RAY TABLE
- K914447 — GORE-TEX(R) VASCULAR GRAFTS, PROCESS CHANGE
- K914448 — GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE
- K914450 — GORE-TEX(R) SURGICAL MEMBRANE, PROCESS CHANGE
- K914688 — HEARING AID, UNITRON MODEL VISTA 3000
- K914689 — HEARING AID, UNITRON MODEL VISTA 4000
- K914725 — COORDINATOR, CABLE INPUT
- K914800 — P54 BTE HEARING AID
- K912630 — XKNIFE RADIOSURGERY SYSTEM
- K913516 — MODEL 520A NOVAMETRIX PULSE OXIMETER
- K911587 — K-SOL(TM)
- K911865 — NORTEC CONNECTING TUBE SET
- K912612 — SMOKE/ODOR EVACUATOR #757
- K913136 — LASER ENDOSCOPE DISC DECOMPRESSION KITS
- K913264 — HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE
- K913306 — BONE-TEMNO/STERNUM-TEMNO
- K913321 — HOLOGIC QDR-2000 X-RAY BONE DENSITOMETER
- K913325 — 40-140 SPIN ECHO FLOW COMPENSATED PULSE SEQUENCE
- K913369 — MICRO-AIRE MODEL 2060
- K913494 — TELEX TDR-4AA MONAURAL HEAR AID/WIRELESS FM REC
- K913495 — TELEX TDR-7AA BINAURAL HEAR AID/WIRELESS FM REC
- K913526 — SERAFLO ARTERIAL AND VENOUS BLOODLINE SETS
- K913568 — SURGI-SPRAY O.R. IRRIGATION SYSTEM
- K913578 — MILESTONE MS 525 RADIOGRAPHIC X-RAY GENERATOR
- K913620 — ENEMA KIT
- K913881 — ENDOSTAT ELECTROSURGICAL UNIT
- K913911 — ABUSCREEN(R) RADIOIMMUNOASSAY FOR METHAMPHE/AMPHET
- K913950 — DUO-FLUX(R) ULTRA HIGH PERFORM ARTIFICIAL KIDNEY
- K913999 — NEZHAT DORSEY SUCTION PROBE W/INNER IRRIGA TUBE
- K914019 — MRP-5000 HS/MR QUADRATURE BODY COIL(P/N MR-QBC-31)
- K914348 — ER-1000 CATHERIZATION C-ARM SYSTEMS
- K914509 — ABUSCREEN(R) ONLINE(TM) FOR BENZODIAZEPINES
- K901186 — MONOCLONAL ANTIBODY ANTI-CD19
- K901187 — MONOCLONAL ANTIBODY ANTI-CD2
- K901188 — MONOCLONAL ANTIBODY ANTI-CD5
- K901189 — MONOCLONAL ANTIBODY ANTI-CD3
- K910473 — CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC
- K910530 — CARBON DIOXIDE LASER SYSTEMS W/WAVEGUIDE DELIVERY
- K911434 — THROMBONOSTIKA F1.2
- K911761 — SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATION
- K911767 — ACUSON V510 TRANSDUCER
- K912045 — TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST
- K912085 — ACLAIMS-IS
- K912748 — BINAX EQUATE(R) GLYCOHEMOGLOBIN 3 MINUTE TEST KIT
- K912807 — ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17
Data sourced from openFDA. This site is unofficial and independent of the FDA.