Atlas FDA

1985

4,483 FDA 510(k) clearances · Clearance year

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RecordFirmDate
COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER (K853651)Cook Pacemaker Corp.1985-10-23
E-Z-GUARD MOUTHPIECE (K853402)E-Z-Em, Inc.1985-10-23
SYVA MYCOTRANS MYCOPLASMA TRANSPORT SYSTEM (K854061)Syva Co.1985-10-23
VEDLAR VENTILATOR (MODIFICATION) (K854026)Hamilton Medical, Inc.1985-10-23
MOTOR DRIVE, MECHANICAL SECTOR SCANNING-MOD417 (K850165)Hoffrel Instruments, Inc.1985-10-23
FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT (K853067)Idt, A Division of Whittaker M.A. Bioproducts1985-10-22
ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT) (K854017)Lmd Laboratories1985-10-22
BETA-TSH-IRMA (K853977)Leeco Diagnostics, Inc.1985-10-22
#9431 TELETRACE, TELEPHONE, EKG TRANSMITTER (K852971)Medtronic Vascular1985-10-22
XYLENE SUBSTITUTE (K853694)Lerner Laboratories, Inc.1985-10-22
BIO-TEK EL 401 HANDHELD MICROPLATE WASHER (K853920)Bio-Tek Instruments, Inc.1985-10-22
XYLENE SUBSTITUTE MONTANT (K854083)Lerner Laboratories, Inc.1985-10-22
EDC/TITAN GELISO-TOTAL CPK ISOENZYME PROCEDURE (K852392)Helena Laboratories1985-10-22
GRAM STAIN KIT (K853896)Sigma Diagnostics, Inc.1985-10-22
SENSOR TAPE CAT. NO. ST-45 (K852407)American Omni Medical, Inc.1985-10-21
CERAMIC ALLOY NO. DW 179 (K852895)Williams Gold Refining Co., Inc.1985-10-21
ADVANCED CARDIOVASCULAR SYSTEMS DOUBLE LUMEN BALLO (K853746)Advanced Cardiovascular Systems, Inc.1985-10-21
HA-1000 & HA-500 HYDROXYLAPATITE TOOTH ROOT SUBSTI (K852766)Orthomatrix, Inc.1985-10-21
QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT (K852999)Kallestad Laboratories, Inc.1985-10-21
UV-A SUNTANNING EQUIPMENT (K853911)Eurotan Intl.1985-10-21
SUN KING (K853752)American Chase Company, Inc.1985-10-21
HEMED NEEDLE SUPPORT CATALOG NO. HAP-XXXX (K853731)Gish Biomedical, Inc.1985-10-18
QCT-BONE MINERAL PHANTOM (K852509)Image Analysis, Inc.1985-10-18
DR. BRUNO LNAGE MINI PHOTOMETER (K851575)Texas Medical Products, Inc.1985-10-18
REPAIR KIT QUINTON TRIPLE LUMEN RIGHT ATRIAL CATHE (K853860)Quinton, Inc.1985-10-18
CUI RHINOPLASTY IMPLANTS (K853945)Cox-Uphuff Intl.1985-10-18
5X2 SATALEC CHIROPODY CASE (K853200)Spelna, Inc.1985-10-18
ERIKA ARTERIAL LINE 03-9837-0 (K853962)National Medical Care, Medical Products Div., Inc.1985-10-18
EROSA DISPOSABLE HYPODERMIC NEEDLE (K853980)Rose KG1985-10-18
COMPUTED TOMOGRAPHY COUCH PAD FOR MIN ANALYSIS (K852510)Image Analysis, Inc.1985-10-18
STERILE SOFT TISSUE BIOPSY NEEDLE (K854003)Co-Medical, Inc.1985-10-18
MOBILE OPERATING TABLE FOR ORL MICROSURGERY (K853720)Carl Zeiss, Inc.1985-10-18
MODEL TT25RF (K844178)Inframed, Inc.1985-10-18
KAY PLUS ADULT DIAPER (K853740)Beghin_Say Intl., Inc.1985-10-17
PHADEBACT CSF TEST (K844999)Pharmacia, Inc.1985-10-17
TECHNA VISION, INC. ELECTRIC CHAIR (K853743)Techna Vision1985-10-17
ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER (K850884)Sherwood Medical Co.1985-10-17
HUBOUT (K853287)I M, Inc.1985-10-17
AMERICAN DILATATION SYSTEM (K853274)American Endoscopy, Inc.1985-10-17
OHMEDA HEAT REFLECTING PATCH (K853351)Ohmeda Medical1985-10-17
COBE REN NEW-D DISPENSING KIT (K853817)Cobe Laboratories, Inc.1985-10-17
JELCO & CATHLON IV STRIPED IV CATHETERS-RADIOPAGUL (K853701)Critikon Company, LLC1985-10-17
VIROGEN HERPES SLIDE TEST (K852928)Armkel, LLC1985-10-17
VIAL VENT FILTER (K852467)Baxter Healthcare Corp1985-10-17
TECHNA VISION, INC.ELECTRIC TABLE (K853744)Techna Vision1985-10-17
E-Z P.E.G. W/PERCUTANEOUS ENDOSCOPY GASTROSTOMY (K852535)Tri-Med Specialties, Inc.1985-10-17
LABORIE URODYNAMICS PROCESSOR (K852856)Tridak Division of Indicon, Inc.1985-10-17
COONS GASTROSTICK SYSTEM (K852552)Medi-Tech, Inc.1985-10-17
GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX (K851486)Gould, Inc.1985-10-17
SARNS EVACUPLEGE CATHETER (K853128)3M Health Care, Sarns1985-10-17
VELCRO FISTULA PRESSURE CLAMPS (K853536)Cp Medical1985-10-17
INTERNATIONAL MODEL SC CANAL IN THE EAR HEARING AI (K853172)Int'L Hearing Aids, Inc.1985-10-17
HEM AVE-TOXO TITRATION HEMAGGLUTINATION TEST KIT (K851977)Si Sero-Immuno Diagnostics, Inc.1985-10-16
SURGICAL TAPES CLOTH, PAPER & PLASTIC-BASE (K853820)Abco Dealers, Inc.1985-10-16
NAIL SPLINT (K850803)Inro Medical Designs, Inc.1985-10-16
NEOGUARD REFLECTOR (K853794)Cas Medical Systems, Inc.1985-10-16
H-H HUNTER TENDON ROD (K853437)Holter-Hausner Intl.1985-10-16
DEMAND ACID PHOSPHATASE REAGENT (K853949)Cooper Biomedical, Inc.1985-10-16
PHARMA-PLAST CLINIPAK (K852443)Pharma-Plast USA, Inc.1985-10-16
MEDNOVA SAFETY BAG (K853075)Mednova Corp.1985-10-16
FLEXIROOT (K852305)Facial Alveodental Implant Rehabilitation, Inc.1985-10-16
PEE WEE THERMOMETERS (K853515)Joel R.L. Ehren Kranz1985-10-16
WESCOR MODEL 3700 WEBSTER SWEAT INDUCER (K853973)Wescor, Inc.1985-10-16
DOWNS VPAP CIRCUIT (K852333)Vital Signs, Inc.1985-10-16
STORZ SOLID-STANDOFF PACHYMETRY PROBE (K853087)Storz Instrument Co.1985-10-16
LASE SYSTEM II (K853927)James L. Geraci & Associates, Inc.1985-10-16
KNEE MACHINE (K852977)Kaiser Medical1985-10-16
ASIK 'ONCE' SYRINGE (K852444)Pharma-Plast USA, Inc.1985-10-16
CANON X-RAY IMAGE DISTRIBUTOR (K853984)Canon USA, Inc.1985-10-16
JMS LCC INSULIN SYRINGE (K853838)Jms Co., Ltd.1985-10-16
VENTREZYME, VAST IMMUNOPEROXIDASE ASSAY (K850895)Ventrex Laboratories, Inc.1985-10-16
OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100 (K853786)American Bentley1985-10-16
J & J CARDIOVASCULAR MAXIMA HOLLOW FIBER OXYGENATO (K853251)Johnson & Johnson Professionals, Inc.1985-10-16
H-H HUNTER PASSIVE TENDON IMPLANT (K853436)Holter-Hausner Intl.1985-10-16
INTERFACE MODULES IM 1000 IMAGE COMMUNI-NETWORK (K850417)Impact Systems Corp.1985-10-16
DENTAL PORCELAIN-VARIOUS (K851733)Excelco Intl., Inc.1985-10-16
ATTENDS DISPOS. UNDERPAD (K853880)Procter & Gamble Mfg. Co.1985-10-16
CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036 (K853144)Preco, Inc.1985-10-16
BOEHRINGER LAB SUCTION INTERRUPTER (K853155)Boehringer Laboratories1985-10-16
POLYCARB WATER SET (K853447)Pulpdent Corp. of America1985-10-16
ENDODONTIC ELECTRONIC SPREADER HEATER (K853183)Sturgeon Engineering Co.1985-10-16
V-TREND ASO PLUS LATEX TEST (K853857)Texas Immunology, Inc.1985-10-16
CANON X-RAY 35MM CINE CAMERA CSI-35 (K853983)Canon USA, Inc.1985-10-16
OHMEDA OXYGEN BLENDER (K853905)Ohmeda Medical1985-10-16
TRACOR MODEL RA600 MICROPROCESSOR AUDIOMETER (K853245)Tracor Instruments, Inc.1985-10-16
DOUBLE PUNCTURE INSTRUMENTS (K852901)L.A.S.E.R., Inc.1985-10-16
COOPER LASER SONICS CUSA MODEL 200 (K853143)Cooper Lasersonics, Inc.1985-10-16
LH/FSH RADIOIMMUNOASSAY KIT (K853837)Bioclinical Group1985-10-16
MINNESOTA SCIENTIFIC, INC. OMNI-BEAM (K853948)Minnesota Scientific, Inc.1985-10-16
OMNI-TRACT CHEST WALL & LUNA RETRACTOR (K853947)Minnesota Scientific, Inc.1985-10-16
HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT (K851976)Si Sero-Immuno Diagnostics, Inc.1985-10-16
VISION THEOPHYLLINE (K853834)Abbott Laboratories1985-10-15
IL TEST THEOPHYLLINE ASSAY (K853858)Allied Instrumentation Laboratory1985-10-15
MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS (K852804)Medcyc. Corp.1985-10-15
ALL KINDS OF SUNGLASSES (K853921)Winsburn Company , Ltd.1985-10-15
ORC ORACLE (K853668)Optical Radiation Corp.1985-10-15
ZEISS OPERATING KERATOMETER (K853723)Carl Zeiss, Inc.1985-10-15
XTAL X-150 OPERATING MICROSCOPE (K853855)Xtal Corp.1985-10-15
TDX AMYLASE (K853978)Abbott Laboratories1985-10-15
THE FIELDMASTER MODEL 275 (K852936)Synemed, Inc.1985-10-15
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Track 1985 automatically

Every clearance here is in the API, with alerts when new ones post.