FDA 510(k) clearances — page 1623
clearances on record, most recent first.
Clearances — page 1623
162,201–162,300 of 175,890- K813536 — ASTRA TOTAL PROTEIN REAGENT
- K813538 — PHENYTOIN FLUORESCENT IMMUNOASSAY
- K813539 — GENTAMICIN FLUORESCENT IMMUNOASSAY
- K813540 — A FLUOROMETER
- K812016 — VS600 JET VENTILATOR
- K812808 — BBL DIRECTIGEN TEST KIT
- K812829 — COATEST ANTITHROMBIN
- K812901 — 125I FERRITIN RADIOIMMUNOASSAY KIT
- K812928 — VACU-FIL TRANSFER SET
- K812586 — KANTRON 504 HEARTSTATION
- K812739 — VITALOG PMS-8 MONITOR
- K812851 — SBP-16 CLINIC MUSCLE STIMULATOR
- K812914 — MICRO-PREPROCESSOR UNIT
- K812955 — EAST WATER UNIT MARK 3
- K812971 — CARDIOINTEGRAM
- K813064 — TELEMETRY TRANSMITTER & RECEIVER
- K813081 — HISTOCAN BIOPSY NEEDLE
- K813163 — SUCTION CATHETER
- K813176 — GEL ELECTRODE
- K813195 — MEDIFIX GRADUATED SCALE
- K813196 — IMAGE ANALYSIS CENTER
- K813217 — DIGITAL FLUROGRAPHIC IMAGING SYSTEM
- K813222 — MODEL 4200 ELLESTAD STRESS TEST ANALYZER
- K813230 — AFTERLOADING GYNECOLOGICAL APPLICATOR
- K813245 — O'CONNOR HOOK PUNCH FORCEP
- K813271 — TEMPERATURE PROBES
- K813284 — VENOUS CANNULA TRAY
- K813296 — CONVERTORS STERILE DISP. LAP SPONGE II
- K813308 — DOUBLE SEAL TUBEGUAZE STERILE BANDAGE
- K813323 — THIGH CUFF: X-LARGE CUFF
- K813324 — BODAI SWIVEL Y
- K813331 — P51 ANGIOPLASTY PRESSURE TRANSDUCER
- K813358 — GERARD MEDICAL ELECTRODE TESTER
- K813387 — METRONIDAZOLE 80MCG. SENSI-DISC
- K813430 — TISSUE PROCESSING CASSETTES & ACCESS
- K813438 — PNEUMO PULSSOR
- K813442 — CEFINASE TM DISCS
- K813444 — NIHON KOHDEN HEART MONITORS OMP 7101-02
- K813461 — PERCUTANEOUS ENTRY NEEDLE, SELDINGER
- K813471 — LINE POWERED LOW ENERGY DEFIBRILLATOR II
- K813472 — LS 5800 SERIES LIQUID SCINTILLATION
- K813499 — OMED DISPOSABLE BULLDOG
- K813501 — TRANSCUTANEOUS ELEC. NERVE STIMULATOR
- K813502 — NARCO TELECARE ISOFLO PRESSURE MONITOR
- K813508 — SAC-CEL
- K813512 — RHESUS MONKEY BLOOD IN ALSEVER'S
- K813514 — EDSLAB CATHETER COVER
- K813516 — MRI TOBRAMYCIN RIA KIT
- K812987 — AGGLUTEX METHAQUALONE TEST KIT
- K813213 — SHARIA-LH RIA KIT FOR QUANTITATION HORMO
- K813326 — TROCKI BODY VENTRILATOR
- K813349 — BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL
- K813366 — AMMONIA TEST
- K813369 — GRAM STAIN REAGENTS AND KIT
- K813370 — ELECTROLYTE GEL
- K813373 — VYGON ENDOTRACHEAL TUBES
- K813392 — RADIOIMMUNOASSAY FOR HUMAN THYROID
- K813400 — INORGANIC PHOSPHORUS REAGENT SET
- K813401 — COAT-A-COUNT TESTOSTERONE RIA KIT
- K813405 — AST(SGOT) IN VITRO DIAG. REAGENT SET
- K813406 — CPK(CK) IN VITRO DIAG. REAGENT SET
- K813426 — MULTIWASH
- K813478 — TRIGLYCERIDE CALIBRATORS
- K813484 — PROGESTERONE KIT BY RIA
- K813063 — FLAT DRAIN
- K813078 — CONTURA DISPOS. SURG. FACE MASK
- K813197 — OXYGEN CONNECTING TUBE
- K813277 — BOUNDARY DRAPE TAPE
- K813278 — VPI URETERAL DILATATION BALLON CATHETER
- K813336 — LAZARUS-NELSON PERITONEAL LAVAGE TRAY
- K813339 — DIRECT FA CONJUGATE FOR LEGIONELLA SP
- K813341 — WOUND-EVAC
- K813391 — TOBRAMYCIN REAGENT TEST KIT
- K813409 — MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER
- K813411 — DOCUMENT LINEARITY TEST STANDARDS
- K813421 — NON-ADHER PADS
- K813423 — THERMOMETER SHEATHS
- K813424 — THERMOMETERS
- K813435 — BAXA ADLI SEAL
- K813440 — PHILLY BOLT
- K812298 — FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN
- K812766 — PCS-5 ACCESSORIES
- K812788 — A-1 TEST
- K812789 — ACU-SLIDE TEST
- K812866 — ASTRA REAGENT CONCENTRATE SYSTEM
- K812950 — QAC CONTROL
- K812994 — MINOCYCLINE 30MCG ANTIMICROBIAL SUS. DSK
- K813031 — MS-2 BACTERIAL IDENTIFICATION SYS
- K813086 — ANDRIA-FSH RIA TEST KIT
- K813087 — ABURIA-CK RIA TEST KIT
- K813216 — SECURE FDI TEST KIT
- K813219 — CARAFLEX ELASTIC POLYMER PLASTER BANDA
- K813261 — RIAGEN PAP RIA
- K813272 — A-1 IN-HOME PREGNANCY TEST
- K813288 — NEIA TRANSFERRIN ENZYMEIMMUNOASSAY
- K813293 — ORTHO CO2 DILUENT LEVEL I
- K813294 — ORTHO CO2 DILUENT LEVEL II
- K813295 — ORTHO CO2 DILUENT LEVEL III
- K813309 — RA-80 POSITIVE CONTROL
- K813310 — NO-HOIL COMBOSTAT II KIT
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