Atlas FDA

1983

3,564 FDA 510(k) clearances · Clearance year

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RecordFirmDate
DULBECCOS MODIFIED EAGLES MEDIUM D5648 (K832842)Sigma Chemical Co.1983-09-29
SPIRO ANALYZER ST-100 AUTOMATIC SPIRO (K832432)Future Impex Corp.1983-09-29
OCUCARE FREEDOM PACK (K832559)Ocular Innovations, Inc.1983-09-29
SPINNER SALT SOLUTION S-6011 W/EARLES (K832930)Sigma Chemical Co.1983-09-29
NUTRIENT MIXTURE F12 #N6760 W/L-GLUTAM (K832841)Sigma Chemical Co.1983-09-29
DOSIMETRY RELEASE OF RADIATION STERILIZ (K831512)Biomet, Inc.1983-09-29
LEADED X-RAY APRON (K832601)E.M. Adams1983-09-29
STERILE FLUID PRODUCING UNIT #EP550 (K832040)American Cystocope Makers, Inc.1983-09-29
V AGAR (K832954)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-09-29
CULTURE MEDIUM FOR ANTIMICROBIAL SUS (K832243)Carroll Biological Corp.1983-09-29
BIOCHECK PEC-108 PROGRAM-PULSE MONITOR (K831752)Biotechnology, Inc.1983-09-29
MODIFICA- OF EMIT AED ETHOSUXIMIDE ASSAY (K832797)Syva Co.1983-09-29
MILLER/NADLER GLARE TESTER (K832762)Titmus Optical, Inc.1983-09-29
RUBASCAN LATEX CARD TEST (K832228)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-09-29
DULBECCOS PHOSPHATE BUFFERED SALINE (K832835)Sigma Chemical Co.1983-09-29
AMES TDA KANAMYCIN TEST-CONTROL SERUM (K832769)Miles Laboratories, Inc.1983-09-29
BASAL MED. #B9763 W/HANKS SALTS W/L-G (K832836)Sigma Chemical Co.1983-09-29
INTRADISCAL THERAPY TRAY (K832858)Ulti-Med Intl., Inc.1983-09-29
CURIX CAPACITY FILM CENTER (K832603)Agfa-Gevaert, Inc.1983-09-29
FEMORAL CANAL SUCTION TAMPON (K831999)Richards Manufacturer Co.1983-09-29
FLEX BUBBLE TUBING (K832865)Sheridan Catheter Corp.1983-09-29
MACCONKEY'S AGAR PLATE (K832934)Otisville Biotech, Inc.1983-09-29
AGAR PLATE XLD (K832532)Otisville Biotech, Inc.1983-09-29
AUTOMATIC SPIROMETER ST-200 (K832433)Future Impex Corp.1983-09-29
CORONARY ANASTOMOSIS MARKING SYSTEM (K832806)Biotrac Laboratories1983-09-29
WALKING CANE (K832969)Maddak, Inc.1983-09-29
ISOVIS WOUND PROTECTOR (K832874)Ritmed, Inc.1983-09-26
CELL-DYN 900 HEMATOLOGY ANALYZER (K832643)Abbott Diagnostics1983-09-26
UNIVERSAL VOL. VENTILATOR 72 #1626 (K832681)Hudson Oxygen Therapy Sales Co.1983-09-26
DUPONT ISOLATOR 1.5 MICROBIAL TUBE (K832246)E.I. Dupont DE Nemours & Co., Inc.1983-09-26
DIRECTIGEN GROUP B STREP TEST KIT-SERUM (K831991)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-09-26
EARLES BALANCED SALT MIXTURE #E6132 (K832838)Sigma Chemical Co.1983-09-26
SUPERJET BTD BLEEDING TIME DEVICE DISP (K830001)Medprobe Laboratories1983-09-26
EASYTOUCH HEMOGLOBIN REAGENT (K832750)Worthington Diagnostic Systems1983-09-26
LANE ONE (K832770)Loredan Biomedical, Inc.1983-09-26
TRANSGROW MEDIUM (K832862)Troy Biologicals, Inc.1983-09-26
ORAL SAFE (K832359)Great Lakes Orthodontics, Ltd.1983-09-26
TISSUE FORCEPS (K831663)Medcare Products1983-09-26
CERESTORE CORE MATERIAL (K832286)Johnson & Johnson Professionals, Inc.1983-09-26
BREATHING CIRCUIT BACTERIA FILTER (K831856)Vital Signs, Inc.1983-09-26
NUTRIENT MIXTURE F-10 #N6635 W/L-GLUTA (K832837)Sigma Chemical Co.1983-09-26
SELECTRO-DISC (K832436)Lab Ability, Inc.1983-09-26
HEATED GUTTA PERCHA DELIVERY SYSTEM (K832654)Unitek Corp.1983-09-26
MINIMUM ESSENTIAL MED. EAGLE M4642 W/ (K832840)Sigma Chemical Co.1983-09-26
DRAVON T CLAMP (K831842)Dravon Medical, Inc.1983-09-26
MUL-T-PAD (K832819)Gaymar Industries, Inc.1983-09-26
ADVANTAGE SERIES CONTOURED LUMBO SACAR (K832881)Depuy, Inc.1983-09-26
HANKS BALANCED SALT MIXTURE H6136 (K832839)Sigma Chemical Co.1983-09-26
ZOLLER BURNED LIP CONFORMER (K832366)Universal Prosthetics, Inc.1983-09-26
SKIN STAPLING DEVICE SC2000 (K832709)Prosper, Inc.1983-09-26
SABOURAUD DEXTROSE AGAR (K832861)Troy Biologicals, Inc.1983-09-26
MUL-T-BLANKET (K832820)Gaymar Industries, Inc.1983-09-26
NEOCATH 1000 W/HEPCOTE (K832793)Orange Medical Instruments, Inc.1983-09-26
ARTERIAL BLOOD SAMPLING KIT (K832545)Dhd Medical Products Div. Diemolding Corp.1983-09-26
DIAZO COLORIMETRY, BILLIRUBIN (K832870)Pointe Scientific, Inc.,1983-09-26
COLOR-EZE PRE-WASHED LAP SPONGES (K831913)Ormed Mfg., Inc.1983-09-26
TOXO IPA KIT IAN INDIRECT FLUORESCENT (K832069)Bionetic Laboratory Products1983-09-26
QUANTUM II YEAST IDENT. SYSTEM (K832406)Abbott Laboratories1983-09-26
SXT BLOOD AGAR (K832860)Troy Biologicals, Inc.1983-09-26
ECOLYZER #200/COHB ANALYZER SYS (K832655)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-09-26
TRAVELER NEBULIZING SYSTEM (K832220)Medix of Florida, Inc.1983-09-26
STREP ID QUAD (K832863)Troy Biologicals, Inc.1983-09-26
OXYGEN CONNECTING TUBESET-RESPIRATORY (K832660)San Diego Plastics, Inc.1983-09-26
VILENE COTTON GAUZE II (K831917)Hall-Tech1983-09-26
BACTIGEN S. PNEUMONIAE (K831887)Armkel, LLC1983-09-26
DIGIDENT ELEKTRONIC APEX LOCATOR (K832118)Ora-Muszeripari Szovetkezet1983-09-26
APNEA ALARM FOR ADULT-PEDIATRIC & NEON (K831601)Plasmedics, Inc.1983-09-26
TOXO-SCREEN DA TEST (K831930)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-09-26
MIDDLEBROOK ADC ENRICHMENT (K832902)Gibco Laboratories Life Technologies, Inc.1983-09-26
RESUSCITATION VALVE (K832868)Boehringer Laboratories1983-09-26
EPIDURAL SYRINGE (K832778)Concord Laboratories, Inc.1983-09-26
POTASSIUM TEST KIT (K832553)Mallinckrodt Critical Care1983-09-20
BIOSPAL 1200S (K832659)Hospal Medical Corp.1983-09-20
BRADFORD SPINAL FRACTURE FIXATION SYS (K831982)Depuy, Inc.1983-09-20
ELEVATOR CUSHION (K832472)Inmed Corp.1983-09-20
OC3 FLYER (K832745)Intl. Medical Equipment Corp.1983-09-20
SODIUM TEST KIT (K832552)Mallinckrodt Critical Care1983-09-20
VENTRE/SPEC ALLERGEN CONTROL-MOLDS/FOOD (K832217)Ventrex Laboratories, Inc.1983-09-20
EPSILON TSH TEST KIT (K831972)Beckman Instruments, Inc.1983-09-20
EARLY IN HOME PREGNANCY TEST (K832599)Warner-Lambert Co.1983-09-20
FEMORAL FRACTURE ORTHOSIS (K832740)Orthomedics1983-09-20
RISER STANDUP WHEELCHAIR (K832696)Imex Medical Systems, Inc.1983-09-20
ACCLAIM (K832648)Electro-Nucleonics Laboratories, Inc.1983-09-20
JASON CERVICAL ORTHOSIS (K832741)Orthomedics1983-09-20
SESAM TABLE (K832804)Electro-Med Health Industries, Inc.1983-09-20
WHEELCHAIR-VARIOUS MODELS (K832685)Health America1983-09-20
INTUBATION KIT (K832629)Calbio, Inc.1983-09-20
SHILEY 3L CARDF PLUS (K832811)Shiley, Inc.1983-09-20
PRE-BYPASS FILTER #EC-PBF SERIES (K832594)Gish Biomedical, Inc.1983-09-20
SCLERAL BUCKLING IMPLANTS DIF/TYPES (K832481)Storz Instrument Co.1983-09-20
POSIDYNE SOLUTION CONTAINER FILTER (K831882)Pall Biomedical Products Co.1983-09-20
STEAM PAK MOIST HEAT (K832803)Electro-Med Health Industries, Inc.1983-09-20
SERA-TEK MYCOPLASMA ANTIBODY TEST (K832132)Miles Laboratories, Inc.1983-09-20
HIP PROSTHESIS -VARIOUS (K831420)The Oec Group1983-09-20
BIOSPAL 3000 S (K832645)Hospal Medical Corp.1983-09-20
ALLERGEN CONTROL INHALENT (K832218)Ventrex Laboratories, Inc.1983-09-20
MOBIE (K832727)Everest & Jennings, Inc.1983-09-20
S & W SW52E W/POWER BACK LIFT (K832768)S & W Enterprises, Inc.1983-09-20
BRONCHO FIBERSCOPE FB-19C (K832492)Pentax Precision Instrument Corp.1983-09-20
HERPES IDENT. & TYPING TEST HITT (K831504)Electro-Nucleonics Laboratories, Inc.1983-09-20
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Every clearance here is in the API, with alerts when new ones post.