FDA 510(k) clearances — page 1202
clearances on record, most recent first.
Clearances — page 1202
120,101–120,200 of 175,890- 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
- K912889 — OIA STREP A
- K913235 — DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH
- K913317 — MEGA ARTHROGRAM KIT
- K913397 — MEGA ANGIOGRAM KIT
- K913451 — HEWLETT-PACKARD MODEL 78720AC ARRHYTHMIA MONIT SYS
- K914039 — SODIUM REAGENT SET
- K914672 — QR-50-E DISPOSABLE RADIOTRANSLUCENT ECG ELECTRODE
- K911315 — EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT
- K911975 — SMT-100X
- K912030 — CDI(TM) 2000 BLOOD GAS MONITORING SYST, MODIFIED
- K912142 — MICRONAIRE ISO-HOOD MAX 5UV
- K912331 — URS-HYDRO-DILATOR MODEL NUMBER 2164.00
- K912910 — C100 INFANT INCUBATOR SHELF/MOUNT RAIL SYSTEM
- K912997 — MINIFLEX AND PERSONAL UNIT
- K913058 — REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172
- K913475 — MAGNETIC RESONANCE DIAGNOSTIC DEVICE
- K913489 — SIEMENS MICRO2 PULSE OXIMETER
- K913652 — COFFMAN TOMOGRAPH
- K913718 — PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED
- K913719 — PANCRETEC I.V. MODEL 5500 INFUSER
- K913720 — PANCRETEC PROVIDER ONE INFUSION SYSTEM, MODIFIED
- K913757 — HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST
- K913782 — TCAL ABUTMENT
- K913815 — AUTOMATED BIOPSY DEVICE, MODIFICATION
- K913884 — FUJI II LC
- K913992 — ASPIRATION/INJECTION NEEDLE
- K914034 — INFUCARE SYRINGE PUMP TUBING SET
- K914040 — PHOSPHOLIPID REAGENT SET
- K914095 — PEEPERS TANNING GOGGLES
- K914120 — SINGLE USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT
- K914179 — CARDIOFOCAL COLLIMATOR
- K914301 — GEN-X 800/800
- K914302 — GEN-X 800/650
- K914377 — TROCAR
- K914468 — ABUSCREEN(R) ONLINE(TM) FOR BARBITURATES
- K914469 — CHOLESTECH LIPID MONIT SYST, TOTAL CHOL/TRIG PANEL
- K913415 — AESCULAP TITANIUM BONE SCREWS
- K910778 — STEAM VACUUM PULSE STERILIZER SYSTEM (SVPSS)
- K911251 — FLEX-IV
- K911965 — ELECTRONIC DIGITAL BLOOD PRESSURE/PULSE MONITOR
- K912014 — TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODES MDL. 2
- K912573 — VISION (NUCLEAR MEDICINE COMPUTER)
- K912604 — SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF
- K912897 — SCEPTOR IDENTIFICATION SYSTEM
- K912987 — CRYSTAL FOCUS EMER LASER PHOTO VIS RED OPER MODE
- K913080 — OPUS(R) ANTI CMV-M
- K913405 — KAR-D-TEK
Data sourced from openFDA. This site is unofficial and independent of the FDA.