Atlas FDA

1984

4,397 FDA 510(k) clearances · Clearance year

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RecordFirmDate
VILENE SURGICAL MASK 5505 (K840090)Hall-Tech1984-04-25
BOUNDARY SINGLE-USE GOWNS (K841255)Procter & Gamble Mfg. Co.1984-04-25
SINGLE LUMEN SUBCLAVIAN CANNULA (K840197)Shiley, Inc.1984-04-25
PENROSE DRAINS (K841037)Inmed Corp.1984-04-25
WILLIAM HARVEY H-4720 NON-FILTERED CAR (K841175)C.R. Bard, Inc.1984-04-25
PRESSURE SENTRY TOURNIQUET (K840206)Richards Medical Co., Inc.1984-04-25
TUBE-BANDAGE FOR HUMAN DIGITS 200 (K840107)Zens Health Care Products1984-04-25
SDL-30 (K834280)Shimadzu Corp.1984-04-25
DIAMOND LUSTRE (K840254)Jelrus Technical Products Corp.1984-04-25
SURGI-MED TABLE MODEL 485-LT (K841505)Midmark Corp.1984-04-25
SECURLINE SURGICAL SKIN MARKER 1000 (K840820)Precision Dynamics Corp.1984-04-25
PERIO PIK (K840721)Teledyne, Inc.1984-04-25
SUN BEDS (K840931)Wakewood Sunbeds1984-04-25
MODULAR CONSTRUCT FRAME EXTERNAL FIXA (K840856)Precision Medical Devices, Inc.1984-04-25
FIBERGLASS MOUTH MIRRORS (K841199)Henry Schein, Inc.1984-04-25
SILICONE SUMP DRAIN 20 & 40 FRENCH (K840324)Superior Plastic Products Corp.1984-04-25
QTA PROCESSOR MODULE (K840138)General Electric Co.1984-04-25
TRILICON BREASE PROSTHESIS DIFFERENT (K841171)Baurs Krey Assoc., Inc.1984-04-25
VIRGO REAGENTS INDIRECT FLUORSCENT (K841127)Electro-Nucleonics Laboratories, Inc.1984-04-25
REPLACE-A-TIP LOW TEMP. CAUTERY (K840434)Suncoast Medical Manufacturers, Inc.1984-04-25
CRYSTAR PORCELAIN MARGIN POWDER/LIQUID (K840873)Shofu Dental Corp.1984-04-25
PHASE II FREE T4 KIT (K840901)Medical & Scientific Designs, Inc.1984-04-25
TOTAL BILIRUBIN REAGENT (K840486)Somas Medical Industries, Inc.1984-04-25
HOLE CHAMFERING DEVICE (K841298)Techmedica, Inc.1984-04-25
TOGGLE LOCKING PLIER (K840978)Med-Tool, Inc.1984-04-25
SHARPLAN #734 LASER SURGICAL UNIT (K832550)Laser Industries , Ltd.1984-04-25
ENDO BITE BLOCK (K833491)American Endoscopy, Inc.1984-04-25
INFECTION CONTROL VALVE (K841480)Superior Plastic Products Corp.1984-04-25
BLOOD MONITOR BMM 10-4 (K831404)Gambro, Inc.1984-04-25
MONITOR CO2 LASER SURGICAL SYSTEM (K840145)Cooper Lasersonics, Inc.1984-04-25
SHUTT PRECISION PROBES (K840558)Concept, Inc.1984-04-25
DENTAL HANDPIECE (K840690)Pen-Med Technology, Inc.1984-04-25
DISPOSABLE SUCTION TUBING SET (K841283)Aesthetech Corp.1984-04-24
FLEXIBLE ILLUMINATOR 15 (K840372)Suncoast Medical Manufacturers, Inc.1984-04-24
HEARING AIDS IN-THE-EAR (K840728)Hearing Instruments, Inc.1984-04-24
MINOR SURGICAL LIGHT MODEL 180 (K841360)American Sterilizer Co.1984-04-24
ELECTRICAL NEURO-MUSCULAR STIMULATOR (K840895)Richards Medical Co., Inc.1984-04-24
KOSMEDICO GMBH SUNLAMP PRODUCTS (K840158)Kosmedico, Kosmetische & Medizinisch1984-04-24
MALE-MALE LUER LOCK CONNECTOR W/ROTA (K840797)American Pharmaseal Div. Ahsc1984-04-24
VASCULAR-ACCESS PORT - ENLARGEMENT (K841149)Norfolk Medical Products, Inc.1984-04-24
PETRUS IOL GUIDE (K840104)Precision-Cosmet Co., Inc.1984-04-24
INTRADISCAL THERAPY NEEDLE 18 GAUGE (K840922)Dlp, Inc.1984-04-24
PROVAC WOUND DRAINAGE & HEALING SYS (K840913)Meyer Medical U.S.A., Inc.1984-04-24
ESCHMANN DILATION CATHETER (K833742)Vertex Medical Corp.1984-04-24
HEMOFILTRATION CATHETER HF-100 (K840322)Vas-Cath of Canada , Ltd.1984-04-24
VAS-CATH DSA CATHETER/TRAY (K834232)Vas-Cath of Canada , Ltd.1984-04-24
EMIT QST PRIMIDONE ASSAY (K840939)Syva Co.1984-04-24
MISTY OX DISPOS. NEBULIZER (K841469)Medical Molding Corp. of America1984-04-24
SURGICAL INSTRUMENT DEMAGNETIZER (K841086)Scanlan Intl., Inc.1984-04-24
SCIMED MODEL SC4000 (K840610)Scimed Life Systems, Inc.1984-04-24
PERCUTANEOUS TRIG. FINGER RELEASE KNIFE (K841320)Anapach Effort, Inc.1984-04-24
SHEATHS FOR REINFORCING BONE CEMENT (K834499)Mecron Medical Products, Inc.1984-04-24
TANSEEKER (K840132)Senator Leisure Products, Ltd.1984-04-24
FLEXIBLE ILLUMINATOR 10 (K840373)Suncoast Medical Manufacturers, Inc.1984-04-24
FLEXIBLE ILLUMINATOR 5 (K840371)Suncoast Medical Manufacturers, Inc.1984-04-24
LUMELEC ELECTRODE CATHETER (K834416)Cordis Corp.1984-04-24
FRASER HARLAKE HOPE III RESUSCITATOR (K841496)Fraser Harlake, Inc.1984-04-24
ULTRAVIOLET TANNING SYSTEMS (K840133)Merrittan Sunfun, Inc.1984-04-24
TRANSCUTANEOUS 800-OXYGEN MONITORS/801 (K840993)Novametrix Medical Systems, Inc.1984-04-24
VASCULAR ACCESS PORT CHANGES IN MATER (K840788)Norfolk Medical Products, Inc.1984-04-24
FIBER HEMOFILTERS FH55-FH77 & 88 (K840720)Gambro, Inc.1984-04-24
FR MEDICAL X-RAY FILM (K840806)Fr Medical/Fr Chemicals1984-04-24
OMNISTIM III INTERFERENTIAL THERAPY (K841278)Physio Technology, Inc.1984-04-24
TOXOPLASMA GOND II IGG DIA TEST KIT (K833829)Labsystems, Inc.1984-04-24
COMBO UVB/UVA TANNING BOOTHS 8-40-12-36 (K832482)Sun Shanty, Inc.1984-04-24
PTCA BALLOON CATHETERS & ACCESS. (K834433)Advanced Cardiovascular Systems, Inc.1984-04-24
VASCULAR-ACCESS PORT CHANGE CATHETER (K841150)Norfolk Medical Products, Inc.1984-04-24
POSIDYNE I.V. FILTER/AIR ELIMINATOR (K834381)Pall Biomedical Products Co.1984-04-24
SYSTEM 5000 (K833756)Medical Graphics Corp.1984-04-24
DERMOLAS (K832983)Meditec, Inc.1984-04-23
STERILE ABSORBENT GAUZE BURN & SOUND (K840745)Chesebrough-Pond'S U.S.A. Co.1984-04-23
FIXATION STAPLE KIT - DLIDE HAMMER (K834515)Stryker Corp.1984-04-23
SILGMANN SOLARIUM S-TYPE 1218 COMBO (K840137)Tannhut1984-04-23
ELMED WMC 10 AND BC 50 M/M (K832589)Elmed, Inc.1984-04-23
NEURO SPONGE (K840541)Surgicot, Inc.1984-04-23
NEUROLOGICAL SPONGE ON PLASTIC STICK (K833734)American Medical Disposable, Inc.1984-04-23
PACEMAKER PULSE GENERATOR W/ELECTRODE (K840353)Ross Research, Inc.1984-04-23
FIXATION STAPLES (K834513)Stryker Corp.1984-04-23
REPTILASE-R HA35 (K840210)Wellcome Diagnostics1984-04-23
STRAITH DRAIN INSERTER (K840835)Surgical Technology Laboratories, Inc.1984-04-23
LINEAR SCANNER 640 (K840667)Ge Medical Systems Information Technologies1984-04-23
CO2 LAPAROSCOPE (K841668)Laser Spectrum, Inc.1984-04-23
SHARPLAN #745 LASER SURG. UNIT (K832551)Laser Industries , Ltd.1984-04-23
AAP DOSIMETRY RELEASE OR BASIN SETS (K832826)American Hospital Supply Corp.1984-04-23
AN ODOR ABSORBENT BANDAGE (K833735)American Medical Disposable, Inc.1984-04-23
CATEGORY 1 CIRCULATORY SYSTEM DEVICE (K840305)Imm Enterprises , Ltd.1984-04-23
CAT. 14-CLINICAL TOXIOLOGY DEVICES (K840318)Imm Enterprises , Ltd.1984-04-23
ADHESIVE TRACTION TAPE (K834142)Devon Industries, Inc.1984-04-23
SD PLUS PATIENT CAT.#78-8010 (K840963)Codman & Shurtleff, Inc.1984-04-23
DISPOSABLE, PRESSURE RELIEF VALVE (K840276)Hospitak, Inc.1984-04-23
JANACEK TUBO-UTERINE IMPLANTATION SET (K840766)Cimed Intl., Inc.1984-04-23
DIACELIN (K840288)Diatech, Inc.1984-04-23
CRYO SURG 5900 (K840536)Frigitronics of Connecticut, Inc.1984-04-23
EPITRON SUPER (K834572)Leo Unlimited, Inc.1984-04-23
ULTRA IMAGER 2000 (K834282)Honeywell, Inc.1984-04-23
FPP ARMBOARD STRAP (K840684)Fpp, Inc.1984-04-23
SD PLUS CLINICIAN CAT# 78-8015 (K840964)Codman & Shurtleff, Inc.1984-04-23
SURG A STAT FINE TIP 5 (K840493)Suncoast Medical Manufacturers, Inc.1984-04-23
SURG-A-STAT FINE TIP 2 (K840585)Suncoast Medical Manufacturers, Inc.1984-04-23
UTERINE MANIPULATOR 4.5MM (K841681)Humi Corp.1984-04-23
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