Atlas FDA

1985

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

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RecordFirmDate
DIAMENTOR PATIENT X-RAY EXPOSURE INDICATOR 07302 (K853753)Victoreen, Inc.1985-10-02
PARA CON TM (K853715)Para Scientific Co.1985-10-02
IMPLANT ELECT LEAD, MOD 030-405 USING POLYU 90 A (K852708)Telectronics, Inc.1985-10-01
VARIOUS FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY (K853502)Bivona Medical Technologies1985-10-01
EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE (K852391)Helena Laboratories1985-10-01
EMIT QST CARBAMAZEPINE ASSAY (K853835)Syva Co.1985-10-01
SUN TANNING BED MODEL EC-3RF (K853692)Mottek Intl. Corp.1985-10-01
INTERNATIONAL MODEL SC SEMICANAL IN THE EAR HEAR A (K853171)Int'L Hearing Aids, Inc.1985-10-01
BETA-HCG MICROTITER PREGNANCY TEST (K853258)Modern Diagnostics, Inc.1985-10-01
UVATAN INDUS. UVATAN 900C, 900B/800 & 600C (K853587)Uvatan Industries , Ltd.1985-10-01
31ST. CENTRUY MEDICAL CORP TIME BUYER 428905 US PE (K853345)31st. Centruy Medical Corp.1985-10-01
SUNJET MODELS 240/280 (K853679)Sunjet Manufacturer, Inc.1985-10-01
SOLCO BASLE INTRAOPERATIVE AUTOTTRNSFUS (K843821)Solco Basle, Inc.1985-10-01
VENTRESCREEN HCG URINE (K853748)Vxr, Inc.1985-10-01
FLOURESCENT T12 UVA TANNING LAMP (K853545)Light Sources, Inc.1985-10-01
EFFNER-SALING LARYNGOSCOPE FOR NEW-BORN (K844776)Medical Instruments and Lamps1985-10-01
MODEL 486-03 POLY FLEX IMPLANTABLE PACING LEAD (K853411)Intermedics, Inc.1985-10-01
LASERSAFE PERSONNEL AND PATIENT SHIELDS (K852405)Lasersafe, Inc.1985-10-01
MULTIPURPOSE IMMUNOCHEMISTRY SYS-LA-2000 (K853391)Eiken Chemical Co., Inc.1985-10-01
PORTALASE 200 CARBON SURGICAL LASER SYSTEM (K852694)Minnesota Laser Corp.1985-09-30
LKB 4057 ULTROSPEC II E (K852538)Lkb Instruments, Inc.1985-09-30
THERA-TRONIC THERAPEUTIC TREATMENT TABLE (K852651)Rwm Co.1985-09-30
TUF TRACK MODEL TT83 CUBICLE TRACK & IV83 INTR TRK (K852938)Northern Customfab, Inc.1985-09-30
BIO MEDICUS BIO PUMP MODEL BP-80 (K852698)Bio Medicus, Inc.1985-09-30
AMOENA BREAST FORMS (K853822)Coloplast Corp.1985-09-30
BCD PLUS BLOOD CARDIOPLEGIA SYS(HEREAF REFER DEV) (K852780)Shiley, Inc.1985-09-30
LODE COAGULOMETER MODEL LC-6 (K852450)Lode Corp.1985-09-30
URIC ACID(URICASE) FOR CONTINUOUS FLOW INSTRUMENTS (K853825)Catachem, Inc.1985-09-30
ALBUMIN SR LIQUID STABLE REAGENT SET (K853868)Medical Analysis Systems, Inc.1985-09-30
BIO MEDICUS BIO PUMP MODEL BP-50 (K852807)Bio Medicus, Inc.1985-09-30
MR 650 MICROPLATE READER(CAT. NO. 011-973-0500) (K852411)Dynatech Laboratories, Inc.1985-09-30
THERMO SHORTWAVE DIATHERMY (K852166)Zimmer Elektromedizin GmbH1985-09-30
GLUCOSE HEXOKINASE FOR CONTINUOUS FLOW INSTRUMENTS (K853826)Catachem, Inc.1985-09-30
LIQUI-SERA CHEM. MULTIPLE CALIBRATORS (K853887)Biodiagnostic Intl1985-09-30
BIO AUTOMED SYS CHEMISTRY ANALYZER AUTO-LOADER (K853453)Bio Automed Systems, Inc.1985-09-30
H-H HUNTER ACTIVE TENDON IMPLANT (K853438)Holter-Hausner Intl.1985-09-30
DEXTRA PRECISION POWER SYSTEM (K853489)Chattanooga Group, Inc.1985-09-30
SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLT (K852946)Miles Laboratories, Inc.1985-09-30
WUNDERSHADE (K852868)Harry J. Bosworth Co.1985-09-27
NOVATHERM (K851034)Medtech Products, Inc.1985-09-27
MODEL MT-50 DIGITAL MEMORY FEVER & BASAL THERMOMET (K852194)Sharp Electronics Corp.1985-09-27
ARS ENTERPRISES NEW/REMFR'D GP STEAM STERILIZER 81 (K852113)Ars Enterprises, Inc.1985-09-27
MODEL U-1000 ULTRASONIC SCANNER (K851902)Fukuda Denshi USA, Inc.1985-09-27
INTRA VAGINAL TRANSDUCER (K853407)Advanced Technology Laboratories, Inc.1985-09-27
FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10 (K853320)Rastronics USA, Inc.1985-09-27
POLYGEL ULTRASOUND GEL (K851895)Parker Laboratories, Inc.1985-09-27
RHINOTEST MP (K853024)Intertronic, Inc.1985-09-27
PERFECT 10 (K853498)North American Alloys, Inc.1985-09-27
ODONTO TOOTHBRUSH (K852691)Action Hygiene Products, Inc.1985-09-27
DUNN VESSEL OCCLUDER-STERILE (K851739)Richard J. Turner Assoc.1985-09-27
ARS ENTERPRISES PRE-VACUUM STEAM STERILIZER 85000 (K852114)Ars Enterprises, Inc.1985-09-27
SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM (K852608)Ge Medical Systems Information Technologies1985-09-27
TRAUMA STAND (K852952)Xre Corp.1985-09-26
INFLUENZA A2 VIRUS (K843659)Institute Virion , Ltd.1985-09-26
PARAINFLUENZA 1 (K843665)Institute Virion , Ltd.1985-09-26
RESPIRATORY SYNCYTIAL VIRUS (K843673)Institute Virion , Ltd.1985-09-26
CYTOMEGALOVIRUS (K843657)Institute Virion , Ltd.1985-09-26
OSTEOGRAF AR ALVEOLAR RIDGE HYDROXYLAPATITE 18-40 (K852742)Coors Biomedical Co.1985-09-26
VARICELLA/ZOSTER VIRUS (K843676)Institute Virion , Ltd.1985-09-26
BONE DENSITY CT PHANTOM (K852528)Computerized Imaging Reference Systems, Inc.1985-09-26
MAXI-NEB (K852627)Ashai Co. , Ltd.1985-09-26
PARAINFLUENZA 3 (K843667)Institute Virion , Ltd.1985-09-26
SENTRY FLEXIBLE TENS (K853552)Sentry Medical Products, Inc.1985-09-26
CLINICOMP RDMS RADIONUCLIDE DISPENSING MGMT. SOFTW (K850838)Clinicomp, Inc.1985-09-26
TRAUMA CARE EVALUATION (K843905)Quantitative1985-09-26
IN FLUENZA B VIRUS (K843660)Institute Virion , Ltd.1985-09-26
ADENOVIRUS (K843649)Institute Virion , Ltd.1985-09-26
SUPERSPIRO (K853190)Cdx Corp.1985-09-26
H. SIMPLEX VIRUS (K843658)Institute Virion , Ltd.1985-09-26
MEASLES VIRUS RUBEOLA (K843662)Institute Virion , Ltd.1985-09-26
COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT (K853100)Cobe Laboratories, Inc.1985-09-25
ABBOTT TESTPACK HCG(URINE) DIAGNOSTIC KIT (K853539)Abbott Laboratories1985-09-25
EASY ANALYZER & EASY-TEST REAGENT (K853699)Diagnostic Systems1985-09-25
CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR (K852382)American Bentley1985-09-25
HOT OR HEAT PACK (K853148)Matrix Intl.1985-09-25
AMERICAN PHARMASEAL TRIPLE LUMEN CATHETER (K852491)American Pharmaseal Div. Ahsc1985-09-25
APOLLO DENSITOMETER (K853734)Astral Medical Systems1985-09-25
ANGIOGRAPHIC, WEDGE PRESS, DUAL THERMOD & INFUSION (K852914)Norton Performance Plastics Corp.1985-09-25
CVERNE CAD DETECTOR (K852900)Cherne Industries, Inc.1985-09-25
VESSA FLIVVA (K853594)Vessa , Ltd.1985-09-24
POWERED IRRIGATION FOR MICRO SURGICAL DRILL (K853659)Acumed Instruments Corp.1985-09-24
HESSBURG GLIDE UNTRAOCULAR LENS GUIDES (K852529)Visitec Co.1985-09-24
CREAT BRAND I/A PACK CREAT BRAND PHACO PACK (K853189)Aesthetech Corp.1985-09-24
RELIANCE 1379 (K853359)Dentsply Intl.1985-09-24
SILASTIC INFLATABLE BONE PLUG H.P. (K853186)Dow Corning Corp. Healthcare Industries Materials1985-09-24
BURS FOR MICRO SURGICAL DRILL SYSTEM (K853658)Acumed Instruments Corp.1985-09-24
HARTSHILL RECT & WIRES, SPINAL FIXATION SYSTEM (K853033)A.W. Showell (Surgicraft) , Ltd.1985-09-24
MUELLER CURVED STEM HEMI-PROSTHESIS (K853662)Protek, Inc.1985-09-24
VESSA TRAVVLA (K853593)Vessa , Ltd.1985-09-24
MICRO SURGICAL DRILL SYSTEM (K853660)Acumed Instruments Corp.1985-09-24
MICRON-SCOPE (K853499)Magnum Diamond, Inc.1985-09-24
GENTLE LIFT-RECLINER CHAIR (K852864)Pride Health Care Equipment1985-09-24
STAINLESS STEEL & CARBON STEEL STERILE BLADES (K853528)Abco Dealers, Inc.1985-09-24
KAMBIN SPINAL INSTRUMENT SET (K853678)Pilling Co.1985-09-24
SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE (K851524)Specialites Septodont1985-09-23
SONOLAYER-L SAL-32B (K851240)Toshiba Medical Systems1985-09-23
HA-2000 HYDROXYLAPATITE (K852765)Orthomatrix, Inc.1985-09-23
HEARING AID MODEL 337D (K853264)Telex Communications, Inc.1985-09-23
DENAR DENTAL IMPLANT (K852802)Denar Corp.1985-09-23
DAHLBERG EA BEHING-THE-EAR HEARING AID (K853323)Miracle-Ear/Dahlberg, Inc.1985-09-23
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Track 1985 automatically

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