FDA 510(k) clearances — page 1463
clearances on record, most recent first.
Clearances — page 1463
146,201–146,300 of 175,890- K854204 — DYNEX REUSABLE, SELF-ADHERING ELECTRODE W/TENS
- K854320 — ACKRAD ORAL SUCTION TUBE
- K854486 — TABLE,RADIOGRAPHIC-FLUOROSCOPIC,TOMOGRAPHIC,REMOTE
- K854601 — SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH
- K854745 — CUSTO VIT PULMONARY FUNCTION ANALYSIS SYSTEM
- K854880 — RADIATION BEAM DATA ACQUISTIOIN SYSTEMS
- K855043 — 3M DRY SILVER IMAGER
- K855058 — EVDS, EVMDS, LDS & IVMCS CENTRAL NERVOUS SYS FLUID
- K855209 — NIR LAT MALE EXTERNAL CATHETER
- K855213 — PET-SCOPE II IMAGE INTENSIFIER
- K855219 — KODAK RP X-OMAT PROCESSOR MODEL M6B
- K860023 — COMPACT 2000 WATER SEAL CHEST DRAINAGE UNIT
- K850855 — TENS GB1001 DEVICE
- K851293 — IMPLANTOFIX
- K853348 — L-CATH EXPANDO CATH
- K853843 — IV MATE
- K853875 — ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY
- K853902 — ENDO-LASE CD40 FOR OTORHINOLARYNGOLOGY
- K854040 — I.V. DRESSING
- K854446 — TERUMO TERUFUSION BLOOD & Y-TYPE ADMIN. SET
- K854562 — CONNECTOR, BLOOD TUBING, INFUSION T. INTRAVENOUS I
- K854628 — CHURCHILL-HCM VENTED IV SET
- K854800 — NORELCO DIGITAL THERMOMETER, MODEL HT 960
- K854966 — ACUTE PERITONEAL DIALYSIS CATHETERS
- K843189 — CYTOMEGALOVIRUS IGG EIA TEST KIT
- K851573 — ABBOTT PHARAMACOKINETICS SYSTEMS
- K853132 — EMERSON TRO/CATH TROCAR CATHETERS
- K853406 — GAMBRO LUNDIA PRO 3 & 5 DIALYZER
- K853747 — NAVIGATOR
- K854113 — CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH
- K854133 — BIO MEDICUS BIO CONSOLE 540
- K854233 — CMI 3000
- K854259 — SEPACELL R-500 & SEPACELL R-500A
- K854282 — PREVIEW XT
- K854357 — GEM-6, WITH COMPONENTS
- K854391 — HEMODIALYSIS CONCENTRATE
- K854397 — HEMOSTATIC SIDEARM
- K854443 — O'NEIL URINARY CATHETER INTRODUCER
- K854523 — ANALYST PHYSICIAN'S OFFICE PROFILER
- K854951 — PLUME Y SET
- K855121 — COLOSHIELD KIT
- K853038 — DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES
- K853951 — ISOTRAK AMYLASE TEST AMYLASE ISOENZYME
- K854041 — CD-100 CARDIAC MONITOR
- K854195 — PROGRAMALITH III MODELS 238 & 239
- K854379 — MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT
- K854546 — MICROSAMPLE COAGULATION ANALYSER MODEL 110P
- K854716 — NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909
- K854838 — LEE-BEAD BETA LH (EIA)
- K854967 — CRITIC - SF, ASSAYED
- K855109 — CLEARENE, CLEARING AGENT
- K855110 — DRI-FORM UREAPLASMA DIFFERENTIAL BASAL AGAR MED.A8
- K852387 — GOODE T-TUBE WHITE SILICONE TYMPANOSTOMY TUBE
- K852947 — ADR 3160 W/PROBES PLB-308M, PLB-508M, & PLB-310M
- K853641 — GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE
- K854089 — DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENT
- K854090 — DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENT
- K854699 — TUBING SYRING
- K850495 — AKUFON THERAPEUTIC MASSAGER
- K852034 — VITATRON M
- K852527 — SATALEC SEPTOSONIC SC 80/SC 120
- K852632 — GAS/PRES MONIT ENDOT TUB CONN/ADOP W/ & W/O TUB
- K853710 — THERACUSHION
- K853849 — MEDAR APM FORCE TRANSDUCER
- K854014 — ASSERA PLATE IX:AG KIT
- K854016 — ASSERACHROM PROTEIN C KIT
- K854081 — IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST
- K854212 — ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR
- K854374 — OXYGEN CONCENTRATOR, MODEL BX-5000
- K854447 — IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST
- K854573 — ANESTHESIA SHUTOFF VALVE POSITIVE CLOSURE
- K854612 — ACUTE HEMODIALYSIS TRAY, CAT.#09-9540-7
- K854632 — ENDOTRACHEAL TUBE GUIDE OR INTUBATION STYLETTE
- K854635 — ELECTRA CHIROPRACT/EQUIP TABLE ELECTRA I&STATIONAR
- K854760 — CHURCHHILL LANCET
- K854861 — SETMA HYGIA BATH MODEL ST 7200
- K854947 — REHABILITATION TABLES
- K854986 — BBL PORT-A-CUL AEROBIC TRANSPORT SYS, MODIFIED STU
- K852866 — HYDRO-BAC FILTER
- K853031 — JECT-AID
- K853069 — TANDEM ICON RUBELLA IGG IMMUNOENZYMETRIC ASSAY KIT
- K853482 — ACE COMPUTER SYSTEM
- K854219 — KODAK M35 X-OMAT PROCESSOR
- K854242 — QBC CENTRIFUGAL HEMATOLOGY SYSTEM
- K854368 — CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER
- K854510 — MINXRAY 500M MAMMOGRAPHIC SYSTEM
- K851972 — DIASONICS ADA400 ADVANCED DIGITAL ARRAY
- K854001 — CERTI-FORM
- K854043 — AUTOMATIC IMPEDANCE AUDIOMETER, TA-7B
- K854052 — CSM MEDIUM
- K854363 — SARATOGA SCT HEATED HUMIDIFICATION SYSTEM
- K840569 — EKG 501 A
- K840571 — EKG 503A
- K842066 — PERI-GUARD PERICARDIAL PATCH
- K843717 — VIRATEK SMALL PARTICLE AEROSOL GENERAT
- K852457 — HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8165
- K852458 — HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8145
- K852459 — HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8175
- K852653 — HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8115
- K853217 — QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES
Data sourced from openFDA. This site is unofficial and independent of the FDA.