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32,815 FDA 510(k) clearances · Device class

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RecordFirmDate
ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL (K855225)Boehringer Mannheim Corp.1986-01-17
CANTROL ELECTROPHORESIS CONTROL (K854931)Canyon Diagnostics, Inc.1986-01-17
KODAK EKTACHEM HDL CHOLESTEROL KIT (K854426)Eastman Kodak Company1986-01-17
CENTRAL VEIN CATHETERIZATION TRAY (K852642)Teleflexmedical, Inc.1986-01-16
INDI KWIK (TM) CO/TWO KIT (K855198)Micro-Bio-Logics1986-01-14
ENZYMATIC CHOLESTROL REAGENT SET (K855187)Technostics Intl.1986-01-14
GAMMA GLUTAMYL TRANSPEPTIDASE (KINECTIC)REAGENTSET (K855186)Technostics Intl.1986-01-14
INORGANIC PHOSPHORUS REAGENT SET (K855154)Technostics Intl.1986-01-14
CONFIDENT ODOR ELIMINATOR (K852471)Hallmark Industries, Inc.1986-01-14
GAMMA GLUTAMYL TRANSPEPTIDASE REAGENT SET (K855156)Technostics Intl.1986-01-14
JUERGENS SELF RELIANT WHEELCHAIR (K860072)E.H. Juergens, Inc.1986-01-13
FALKON STRETCH-STERILE (K854850)G.B.F. Industries, Inc.1986-01-13
TERUMO SENSIBEAD EIA HPRL KIT (K854768)Terumo Medical Corp.1986-01-13
LEE-BEAD BETA FSH (EIA) (K854837)Leeco Diagnostics, Inc.1986-01-13
V-TREND OC CPK (K854973)V-Tech, Inc.1986-01-13
SUTURE REMOVAL KIT (K855131)Dynarex Corp.1986-01-13
COMFORTEX WHEELCHAIR CUSHION (K855181)Comfortex, Inc.1986-01-13
TISSUE CULTURE MEDIA (K855085)Newport Biosystems, Inc.1986-01-13
P.A. MEDICAL VAGINAL IRRIGATION SET #1130 (K854595)Pa Medical Corp.1986-01-13
RANGE-CHEK (K854789)American Monitor Corp.1986-01-13
CNS-16 & LTM 1.0 SOFTWARE (K854160)Cns, Inc.1986-01-10
ACKRAD ORAL SUCTION TUBE (K854320)Ackrad Laboratories1986-01-10
I.V. DRESSING (K854040)Consolidated Medical Equipment, Inc.1986-01-09
CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH (K854113)American Bentley1986-01-08
ANALYST PHYSICIAN'S OFFICE PROFILER (K854523)E.I. Dupont DE Nemours & Co., Inc.1986-01-08
DRI-FORM UREAPLASMA DIFFERENTIAL BASAL AGAR MED.A8 (K855110)Gibco Laboratories Life Technologies, Inc.1986-01-07
CLEARENE, CLEARING AGENT (K855109)Surgipath Medical Industries, Inc.1986-01-07
LEE-BEAD BETA LH (EIA) (K854838)Leeco Diagnostics, Inc.1986-01-07
CRITIC - SF, ASSAYED (K854967)Dimension Diagnostics1986-01-07
TUBING SYRING (K854699)Almore Intl., Inc.1986-01-06
ANESTHESIA SHUTOFF VALVE POSITIVE CLOSURE (K854573)Artec Environmental Monitoring Division1986-01-03
IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST (K854447)American Micro Scan1986-01-03
THERACUSHION (K853710)General Physiotherapy, Inc.1986-01-03
IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST (K854081)Boots-Celltech Diagnostics, Inc.1986-01-03
BBL PORT-A-CUL AEROBIC TRANSPORT SYS, MODIFIED STU (K854986)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-01-03
AKUFON THERAPEUTIC MASSAGER (K850495)Jansson A/S1986-01-03
ELECTRA CHIROPRACT/EQUIP TABLE ELECTRA I&STATIONAR (K854635)Electra Equipment , Ltd.1986-01-03
ASSERACHROM PROTEIN C KIT (K854016)American Bioproducts Co.1986-01-03
REHABILITATION TABLES (K854947)I-Rep, Inc.1986-01-03
GAS/PRES MONIT ENDOT TUB CONN/ADOP W/ & W/O TUB (K852632)Medicomp, Inc.1986-01-03
SATALEC SEPTOSONIC SC 80/SC 120 (K852527)Spelna, Inc.1986-01-03
ACE COMPUTER SYSTEM (K853482)Cardiac Medical Systems Corp.1986-01-01
HYDRO-BAC FILTER (K852866)Medicomp, Inc.1986-01-01
CERTI-FORM (K854001)Beltone Electronics Corp.1985-12-31
THE NEW MCINTYRE I.A. HANDPIECE (K854402)Microsurgical Technology, Inc.1985-12-30
OSM3 HEMOXIMETER (K853990)Radiometer America, Inc.1985-12-30
THE NEW MOBILE TIP MCINTYRE CANNULA (K854401)Microsurgical Technology, Inc.1985-12-30
HI-TECH LAB MODEL CONCHA ALL IN EAR (K853967)Hi-Tech Laboratories, Inc.1985-12-27
PLACIDO DISC (K854054)Cutler Medical Instruments1985-12-27
HYBRID POINTS (K854347)Shofu Dental Corp.1985-12-27
MODEL M HEARING AID (K852656)Magnatone Hearing Aid Corp.1985-12-27
BATTLE CREEK BOARDWALKER ELECTRIC TREADMILL (K854147)Battle Creek Equipment Co.1985-12-27
IN VITRO TEST DETERMINATION OF SGPT(ALT) (K854186)Clinical Data, Inc.1985-12-25
SCALPEL, ONE-PIECE, DISPOSABLE (K854857)Medelec Intl. Corp.1985-12-24
BLADES, SCALPEL STAINLESS STEEL (K854859)Medelec Intl. Corp.1985-12-24
MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY (K854262)Meadox Surgimed, Inc.1985-12-24
RULER (K854892)Euro-Med Intl.1985-12-24
SCALPEL HANDLE (K854858)Medelec Intl. Corp.1985-12-24
RANDALL CURETTE (K854888)Euro-Med Intl.1985-12-24
BLADES, SCALPEL CARBON STEET (K854860)Medelec Intl. Corp.1985-12-24
NOVAK CURETTE (K854899)Euro-Med Intl.1985-12-24
CRITIC C LEVEL I & II (K853943)Dimension Diagnostics1985-12-23
SHAH SELF-CLEARING MASTOID SUCTION TUBE (K853589)Downs Surgical , Ltd.1985-12-23
MICRO-MAT SYSTEM (K854962)Ulster Scientific, Inc.1985-12-23
TRANSPORT CULTURE MEDIA (K854715)Hillcrest Biologicals1985-12-23
AUDTEX 85 (K853895)Cami, Inc.1985-12-20
DSL ACTIVE TESTOSTERONE RIA (DSL #4000) (K854671)Diagnostic Systems Laboratories, Inc.1985-12-19
MEDIPART REMOTE INJECTION SYS FOR ULTRAVENT RADIOA (K854550)Medipart Jerry Alexander1985-12-19
MEDIPART RADIOAEROSOL DELIVERY SYS FOR ULTRAVENT S (K854551)Medipart Jerry Alexander1985-12-19
DSL ANDROSTENDIONE RIA (DSL #4200) (K854674)Diagnostic Systems Laboratories, Inc.1985-12-19
INT'L MODEL XE BEHIND-THE-EAR HEARING AID (K853942)Int'L Hearing Aids, Inc.1985-12-18
DEN-MAT PAINT-ON RUBBER DAM (K852630)Den-Mat Corp.1985-12-18
INT'L MODEL XG BEHIND-THE-EAR HEARING AID (K853941)Int'L Hearing Aids, Inc.1985-12-18
FIBRELIGHT NASAL SPECULA (K853588)Downs Surgical , Ltd.1985-12-18
BATTLE CREEK DIGI-TRACKER ELCTRIC TREADMILL (K854148)Battle Creek Equipment Co.1985-12-17
OVUTIME OVULATION PREDICTOR TEST (K853142)Advanced Care Products1985-12-17
SURGICAL BLADES (K854620)Niraj Industries1985-12-17
SURGICAL INSTRUMENT TRAY (K854746)Zbi, Inc.1985-12-17
TIP OFF FORCEPS (K854541)Keller Instruments, Inc.1985-12-17
X-RAY DETECTABLE COTTON BALLS (K854714)American Silk Sutures, Inc.1985-12-17
HYPODERMIC NEEDLE AND STYLET (K854579)Berkley and Co.1985-12-17
MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50 (K854440)Keeler Instruments, Inc.1985-12-16
DSL PROGESTERONE RIA (DSL #3400) (K854649)Diagnostic Systems Laboratories, Inc.1985-12-13
IN-HOME VISION MONITORING KIT (K854047)Rich-Larky Company, Inc.1985-12-13
700-123 EYE SHADE (K853043)Health Saver Products1985-12-13
CEKK-ADHESIVE MATRIX-MULTIPLE WELL PLATE CAM-PLATE (K854724)Lifetrac, Inc.1985-12-13
EVEREST & JENNINGS BED MODEL NO. L109564 & L108564 (K854776)Carrom Healthcare, Inc.1985-12-13
DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800) (K854650)Diagnostic Systems Laboratories, Inc.1985-12-13
HESSBURG LIGHT GUARD (K853035)Visitec Co.1985-12-13
RESNICK EMITTER, ARTIFICIAL LARYNX (K854158)Dynamed Audio, Inc.1985-12-13
PARAAMAX CHLORIDE DETERMINATION BY ISE (K854651)American Dade1985-12-13
ANTI-EPSTEIN-BARR VIRUS KIT (K842662)Amico Lab, Inc.1985-12-12
KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT (K854483)Kallestad Laboratories, Inc.1985-12-11
DELTA-LITE CASTING RESIN (K854554)Johnson & Johnson Professionals, Inc.1985-12-11
MGA 2000 GAS ANALYSER (K854076)Airspec , Ltd.1985-12-11
PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES (K854232)American Pharmaseal Div. Ahsc1985-12-10
MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC. (K854735)Portable Medical Laboratories, Inc.1985-12-10
STERILE SALINE SOLUTION (K854155)I M, Inc.1985-12-10
PULMO-AIDE MODEL 5610D (K854520)The Devilbiss Co.1985-12-09
MURPHY ADJUSTABLE SPLINT (K854270)Comfortex, Inc.1985-12-09
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