Atlas FDA

1984

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

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RecordFirmDate
IMPULS 3, IT SELECTOR (K842805)Robert Bosch Corp.1984-08-01
PILLOW W/STAPHCHEK TICKING (K842335)Monterey Mills, Inc.1984-08-01
ALLIED ASSOC. THERAPEUTIC EXERCISE EQUIP (K842427)Allied Associates, Inc.1984-08-01
ALLIED ASSOC. THERAPEUTIC EXERICSE (K842426)Allied Associates, Inc.1984-08-01
ADLER CUSTOM PROCEDURE PACKS (K841723)Adler Instrument Co.1984-08-01
ALLIED ASSOCIATES THERAPEUTIC EXERSIE (K842432)Allied Associates, Inc.1984-08-01
THE PATHFINDER (K842304)Hydro-Med Products, Inc.1984-08-01
ALLIED ASSOCIATES THERAPEUTIC EXERCISE (K842425)Allied Associates, Inc.1984-08-01
MS NONPRECIOUS CROWN & BRIDGE ALLOY (K842377)Dental Ventures of America, Inc.1984-07-31
GASTROINTESTINAL DILATOR (K841310)Thomas J. Fogarty, M.D.1984-07-31
CROWN INDEX TRAY (K842273)Di-Equi Dental Products1984-07-31
NATURA-TONE OR LUXOPAL CL ACRYLIC (K842208)Parexel Intl. Corp.1984-07-31
CYSTOFLO ANTIMICROBIAL URINARY DRAINAGE (K832290)Travenol Laboratories, S.A.1984-07-31
ISOLIGHT (K842358)Planmeca USA, Inc.1984-07-31
MONOXYCHLOROSENE WAREXIN (K834455)Guardian Chemical1984-07-31
VAGINAL SPECULUM - DISPOSABLE (K841909)Galenica Enterprises, Inc.1984-07-31
PROTEX CONTRACEPT PLUS W/SPERM-LUB (K842185)National Sanitary Laboratories, Inc.1984-07-31
F-G-P TRAY (K842274)Di-Equi Dental Products1984-07-31
PACKETS FOR THE PREP OF DIALYSATES & (K842154)Organon Teknika Corp.1984-07-31
COOK PACEMAKER CORP. 116 BIOPOLAR CARDI (K843001)Cook Pacemaker Corp.1984-07-30
INFRA-EYE 160 (K841271)Fujitsu , Ltd.1984-07-28
MONITOR ONE (K841172)Qmed, Inc.1984-07-27
REDO CENTRAL VENOUS CATHETER-NEONATE (K841443)Intl. Hospital Products, Inc.1984-07-27
TECHNICON TEST POINT ASSAYED HEMATOLOGY (K842109)Technicon Instruments Corp.1984-07-27
ARM-A-VIAL LV SODIUM CHLORIDE INHALAT (K841989)Armour Pharmaceutical Co.1984-07-27
ARM-A-CARE HUMIDIFIER-RESPIRATORY GAS (K841991)Armour Pharmaceutical Co.1984-07-27
KEYMED SIGMOIDOSCOPE SUCTION UNIT (K841822)Keymed, Inc.1984-07-27
SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH (K842440)Anco Medical Reagents & Assoc.1984-07-27
ECHO PULSE BURST (K842414)Rabar, Inc.1984-07-27
TECHNICON H*1 SYSTEM (K842636)Technicon Instruments Corp.1984-07-27
SIRC (K842583)Viromed Laboratories, Inc.1984-07-27
B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONS (K842579)Biological & Environmental Control Laboratories1984-07-27
CODMAN SUCTION PUNCH-PRODUCT CODES (K842774)Codman & Shurtleff, Inc.1984-07-27
ARM-A-CARE NEBULIZER-NEBULIZER (K841990)Armour Pharmaceutical Co.1984-07-27
RESPIRONICS VENT EASY OXYGEN ENRICHME (K842605)Respironics, Inc.1984-07-27
HEK (K842584)Viromed Laboratories, Inc.1984-07-27
ENTEROPORT NUTRITION PUMP (K841827)Diatek, Inc.1984-07-27
HISTOPAQUE-1077 (K842146)Sigma Chemical Co.1984-07-27
COULTER AUTOMATIC SAMPLE HANDLER (K842346)Coulter Electronics, Inc.1984-07-27
DRYDEN SCAVENGER INTERFACE SYSTEM (K842843)Dryden Corp.1984-07-27
SUNGLASSES (K841248)China Toy & Novelty Co., Ltd.1984-07-27
LIFE-MASK INFANT RESUSCITATOR (K842696)Electronic Monitors, Inc.1984-07-27
ARM-A-VIAL LV STERIAL WATER FOR INHALA (K841987)Armour Pharmaceutical Co.1984-07-27
MIDAS II AUTOMATIC STAINER (K842077)Innovative Medical Systems, Inc.1984-07-27
PARA-TEK (K841531)Streck Laboratories, Inc.1984-07-27
ARM-A-VIAL LV SODIUM, CHLORIDE INHALAT (K841988)Armour Pharmaceutical Co.1984-07-27
SALIVARY BYPASS TUBE (K841350)E. Benson Hood Laboratories, Inc.1984-07-26
INFANT NASAL CANNULAE ASSEMBLY (K841773)Ackrad Laboratories1984-07-26
STERELIS SEALING EQUIPMENT (K842631)Sterelis Corp.1984-07-26
BEAR JET-150 VENTILATOR (K842688)Bear Medical Systems, Inc.1984-07-26
REGULAR PETAL SOFT PLASTIC APPLICATOR (K842619)Tambrands, Inc.1984-07-26
ELECTRODE PLACEMENT ARM PART GARMENT (K842033)Bio-Stimu Trend Corp.1984-07-26
E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS (K841720)E-Z-Em, Inc.1984-07-26
STAR HCG MONOCLONAL ANTIBODY IMMUNO (K842598)Syncor Intl. Corp.1984-07-26
SECHRIST AIR-OXYGEN MIXER & ANCILLARY (K841789)Shiley, Inc.1984-07-26
LFT - 212 (K841879)Medical Monitoring Systems, Inc.1984-07-26
HEMODIALYSIS BATH CONCENTRATE SOLUTION (K842058)Pharmaceutical Development Systems1984-07-26
UNCUFFED REINFORCED TRACHEAL TUBE (K841872)Mallinckrodt Critical Care1984-07-26
DELTON * OPAQUE LIGHT CURING PIT (K842392)Johnson & Johnson Professionals, Inc.1984-07-26
SUPER PETAL SOFT PLASTIC APPLICATOR TAMP (K842618)Tambrands, Inc.1984-07-26
CEFONICID 30 MCG SENSITIVITY DISCS (K842292)Difco Laboratories, Inc.1984-07-26
RAPID PLASMA REAGIN CARD TEST (K842541)Clinical Sciences, Inc.1984-07-26
ENTERAL FEEDING BOTTLE (K841945)Superior Plastic Products Corp.1984-07-26
LUNG ANALYZER CM-310 (K842760)Cybermedic, Inc.1984-07-26
AVATRON UNIVERSAL ADULT VOL. VENTILATOR (K842778)Avatron, Inc.1984-07-26
DUO FLOW CATHETER-MC 54 (K842416)Medical Components, Inc.1984-07-26
STANDARD WHEELCHAIR (K842719)Greene International Corp.1984-07-25
MASSAPED (K842643)Heddernheimer Metallwarenfabrik GmbH1984-07-25
CHEMISTRY ANALYZER, GEN. PURPOSE (K842311)Hml Inc/Biotechnology Transfer1984-07-25
UMBILICAL VESSEL CATHETER (K840339)Catheter Technology Corp.1984-07-25
BALSAN 700 (K842642)Heddernheimer Metallwarenfabrik GmbH1984-07-25
MTP E.V. INFUSION PUMP (K842263)Ziehm International, Inc.1984-07-25
IVENT 302VC DUAL CONTROLLER (K842210)Ivent Corp.1984-07-25
CLINITEK 10 SEMI-AUTO URINALYSIS SYS (K842238)Miles Laboratories, Inc.1984-07-25
SR- MODEL 230 (K842289)Hirata Sangyo Co. USA, Inc.1984-07-25
SHERIDAN/ENDO-PAK (K842635)Sheridan Catheter Corp.1984-07-25
SYVA IQ 190 DIGITAL PIPETTER DILUTER (K842390)Syva Co.1984-07-25
AXIOM STABLE II CHOLESTEROL TEST (K842441)Axiom, Inc.1984-07-25
HYDRO/BUBBLE BATH DEVICE 300 (K842641)Heddernheimer Metallwarenfabrik GmbH1984-07-25
SAFRANIN, 1% W/V (K842920)E K Ind., Inc.1984-07-25
FIRST RESPONSE EMERG. MEDICAL SYSTEM (K841897)Reed Products, Inc.1984-07-23
SINGLE HAIR TRANSPLANT GRAFT (K841741)Paris Products, Inc.1984-07-23
INTRAVENOUS INJECTION SET (K841717)Philadelphia Biologics Center1984-07-23
FIRST RESPONSE EMERG. EYE INJURIES (K841900)Reed Products, Inc.1984-07-23
BUTTERFLY II PN INFUSION NEEDLE (K842756)Cosmetic Sciences, Inc.1984-07-23
DISPOS. ACU-CUT SOFT TISSUE BIOPSY (K842091)The Healthcare Group Laboratories, Inc.1984-07-23
SURG-A-STAT VASECTOMY TIP (K840370)Suncoast Medical Manufacturers, Inc.1984-07-23
OXYMIZER FLOW RESTRICTOR (K841901)Chad Therapeutics, Inc.1984-07-23
AIMED DISPOSABLE SYRINGE, VARIOUS SIZES (K842227)Tech-Cons Ltd., Intl.1984-07-23
ESOPHAGEAL TUBE (K841349)E. Benson Hood Laboratories, Inc.1984-07-23
WIRE (K841628)Plastafil, Inc.1984-07-23
MEDICAL RUBBER GLOVES-STERILE-SURGEONS (K831632)Tagum Rubber Industries, Ltd.1984-07-23
NEUTRAL POS-CHAIR SURGEON CHAIR (K842030)Neutral Pos-Chair Co.1984-07-23
SURG-A-STAT CARDIOVASCULAR TIP (K840377)Suncoast Medical Manufacturers, Inc.1984-07-23
RODY BREAST PUMP (K840874)Kean-Rody Manufacturer1984-07-23
INFANT PERCUSSOR PA-010 (K842608)Alpha Medical Systems1984-07-23
ULTRASOUND PROBE COVERS-STERILE (K842591)Applied Medical Devices, Inc.1984-07-23
PMS SUTURE PACK/TRAY;VERTEX SUTURE (K842149)Professional Medical Services1984-07-23
HESUNG BLOOD TRANSFUSION SETS (K841562)Amkor Trading Co.1984-07-23
FIRST RESPONSE EMERG. MEDICAL SYS BONES (K841899)Reed Products, Inc.1984-07-23
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Every clearance here is in the API, with alerts when new ones post.