Atlas FDA

1984

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

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RecordFirmDate
SYSTEMATE CK-TOTAL - 67206 (K843271)Em Diagnostic Systems, Inc.1984-09-07
HOME NUTRIBAG MIXING CONTAINER 3000ML (K842629)Medical & Pharmaceutical Supplies, Inc.1984-09-07
MONITORING KIT (K833171)Transamerica Delaval, Inc.1984-09-06
CELL-MATICS VIRAL TRANSPORT PACK (K843173)Difco Laboratories, Inc.1984-09-06
AFRICAN GREEN SV 5/SV 40 (K843252)Viromed Laboratories, Inc.1984-09-06
IL TEST ANTITHROMBIN III ACTIVITY (K841736)Instrumentation Laboratory CO1984-09-06
C-PEP-RIA-100 (K842267)Institut National Des Radioelements1984-09-06
HEMATOLOGY ANALYZER (K842310)Hml Inc/Biotechnology Transfer1984-09-06
DILU-MATIC 140 (K842446)Abbott Diagnostics1984-09-06
RD CELLS (K843251)Viromed Laboratories, Inc.1984-09-06
BHK-21 (K843250)Viromed Laboratories, Inc.1984-09-06
TCA HEARING AID (K843067)Telex Communications, Inc.1984-09-05
CUSTOM CANAL HEARING AID X-CITE 84 (K842546)Bernafon, Inc.1984-09-05
UTILITY SCISSORS DISPOSABLE ITEMS (K843075)Greene International Corp.1984-09-05
CORMED HUBER POINT NEEDLE (K843083)Cormed, Inc., Sub. C.R.Bard, Inc.1984-09-05
CALCITONIN RADIOIMMUNOASSAY KIT (K842907)Nichols Institute Diagnostics1984-09-05
OCCULT BLOOD TEST (K842137)Breit Laboratories, Inc.1984-09-05
APR MOBILE (K843192)Philips Medical Systems (Cleveland), Inc.1984-09-05
COMBO SKIN TEST READY TO USE TAPE (K842107)Combion Systems, Inc.1984-09-05
CLINITRON AIR FLUIDIZED SUPPORT J-101UD (K843389)Uhi Corp.1984-09-05
COMBION SKIN TEST - FOUR PRONG (K833999)Nicholas H. Maganias1984-09-05
IN-THE-EAR-CANAL HEARING AID (K842980)Ear Care Hearing Systems, Inc.1984-09-05
EMIT D.A.U. LOW & MED. CALIBRATORS B (K842816)Syva Co.1984-09-05
DISPOSABLE LAPAROTOMY SPONGE (K843037)Anago, Inc.1984-09-05
AMERLEX-M FREE T-3 RIA (K842949)Amersham Corp.1984-09-05
CK10000 SERIES POUCH & BAGS ETC. (K834558)Currie Medical Specialties, Inc.1984-09-05
DOSE RELEASE OF STERILIZATION LOTS (K841949)Medcare Disp Products, Inc.1984-09-05
AMIZYME-SCHISTOSOMA SPP. TEST KIT (K842527)Amico Lab, Inc.1984-09-05
OMED DISPOS. INSTRUMENT GUARDS (K842603)Omega-Med Intl., Inc.1984-09-05
DISPOSABLE STOPCOCKS (K842173)Procedure Products, Inc.1984-09-05
QUIDEL BETA HCG ENZYME IMMUNOASSAY KIT (K842692)Quidel Corp.1984-09-05
AUTOLYZER 800 (K841852)Geometric Data, Div. Smithkline Corp.1984-09-05
COLOTRAK OCCULT BLOOD TEST (K840527)Breit Laboratories, Inc.1984-09-05
TELECTRONICS MODEL 2401 (K831697)Seamed Corp.1984-09-04
CRITIKON HEPARIN-COATED CARDIOVASCULAR (K843141)Critikon Company, LLC1984-09-04
MINGO LOG 7 (K843440)Siemens Elema AB1984-09-04
PERCUFIX CATHETER CUFF (K842890)Medi-Tech, Inc.1984-09-04
BILIRUBIN ASSAY KIT - TOTAL (K843032)Diagnostic Chemicals, Ltd. (Usa)1984-09-04
CORNING MAGIC CORTISOL RADIOIMMUNO (K841641)Corning Medical & Scientific1984-09-04
CHEMISTRY CONSOLE (K842401)Biovation, Inc.1984-09-04
VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC (K843230)Ventrex Laboratories, Inc.1984-09-04
CT 9800 (K841997)General Electric Co.1984-09-04
BILIRUBIN ASSAY KIT DIRECT (K843027)Diagnostic Chemicals, Ltd. (Usa)1984-09-04
AMERLEX-M TSH RIA (K842948)Amersham Corp.1984-09-04
CARDIONOSTICS HOLTER DURA-LITE RECORDE (K842954)Cardionostics, Inc.1984-09-04
ION SELECTIVE ELECTRODES & REAGENT SYS (K843008)American Monitor Corp.1984-09-04
LH RIA (K842445)Syncor Intl. Corp.1984-09-04
ROCHE STANDARDS FOR CHOLESTEROL (K843110)Roche Diagnostic Systems, Inc.1984-09-04
ND. YAG LASER FOR ENDOBRONCHIAL OBSTRUC (K843228)Endo Lase, Inc.1984-09-04
CLARK PRECISION BLOCK CUTTER, COOLING (K842615)Clark Research and Development, Inc.1984-09-04
ACE UNIVERSAL TONG (K842680)Buckman Co., Inc.1984-09-04
LABSYSTEMS FP-901 CHEMISTRY ANALYZER (K842773)Labsystems, Inc.1984-09-04
SANTA BARBARA MEDCO-LANTOPHORETIC APPLIC (K842483)Santa Barbara Medco, Inc.1984-08-31
HESUNG'S BLOOD DONOR SETS (K841561)Amkor Trading Co.1984-08-30
CLOUTIER II TOTAL KNEE W/BEADED SURF (K841517)Zimmer, Inc.1984-08-30
FERRIS VENT-A-DERM (K840152)Ferris Mfg. Corp.1984-08-30
MAXAMAN (K841893)Cryo2 Corp.1984-08-30
LIFE MONITOR I (K842334)St. Croix Medical Systems, Inc.1984-08-30
UV 8001K, PUVA 800, PUVA 180/200 1000 (K841795)Waldmann Lighting Co.1984-08-30
AMERICAN PHARMASEAL I.V. START KIT (K842860)American Pharmaseal Div. Ahsc1984-08-30
EMIT 700 COCAINE METABOLITE ASSAY (K843160)Syva Co.1984-08-29
UNIVERSAL 2 S CENTRIFUGE (K843087)Boehringer Mannheim Corp.1984-08-29
TDX DISOPYRAMIDE (K842713)Abbott Laboratories1984-08-29
CHAD ADJUSTABLE CANNULA (K842968)Chad Therapeutics, Inc.1984-08-29
PORTABLE LIFECARE VENTILATOR PLV-102 (K842876)Lifecare Services, Inc.1984-08-29
EBA 3 S CENTRIFUGE (K843088)Boehringer Mannheim Corp.1984-08-29
EMIT 700 CONTROL SET A (K843161)Syva Co.1984-08-29
MEDTRONIC 8437/8438 (K843089)Medtronic Vascular1984-08-29
ALLERGENTICS TOTAL IGE/THEOPHYLLINE (K842970)Allergenetics1984-08-29
SYSTEMATE CALCIUM 67214 (K843152)Em Diagnostic Systems, Inc.1984-08-29
TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZM (K842470)Miles Laboratories, Inc.1984-08-28
DULBECCO'S MODIFIED EAGLE'S NUTIRENT MIX (K843086)Sigma Chemical Co.1984-08-28
ALLERGENETICS ALLER-SPECIFIC IGE SERUM (K842969)Allergenetics1984-08-28
LIFESCOPE 6 OEC-6105 (K841502)Nihon Kohden America, Inc.1984-08-28
PMK PRIMARY MONKEY KIDNEY-CELLS (K842833)Bartels Immunodiagnostic Supplies, Inc.1984-08-28
LIFESCOPE 6 OEC-6201 (K841500)Nihon Kohden America, Inc.1984-08-28
AMIZYME-LEISHMANIA SPP. TEST KIT (K842526)Amico Lab, Inc.1984-08-28
CB FORMALIN (K842862)Anatech, Ltd.1984-08-28
LIFESCOPE 6 OEC-6102 (K841501)Nihon Kohden America, Inc.1984-08-28
ANTI-TOXOPLASMA GONDII KIT (K842664)Amico Lab, Inc.1984-08-28
CBA FORMALIN (K842940)Anatech, Ltd.1984-08-28
RPMI-1640 MEDIUM #R3505 W/HAT, L-GLUTA (K843085)Sigma Chemical Co.1984-08-28
FIAX TOTAL IGE TEST KIT (K842749)Intl. Diagnostic Technology1984-08-28
TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG (K842468)Miles Laboratories, Inc.1984-08-28
LIFESCOPE II (K841499)Nihon Kohden America, Inc.1984-08-28
HEP-2 CELLS (K842834)Bartels Immunodiagnostic Supplies, Inc.1984-08-28
STROVER HOOK (K841617)Plastafil, Inc.1984-08-27
WBA - I.R.I.S. (K842895)Siemens Gammasonics, Inc.1984-08-27
SYSTEMATE GLUCOSE 67216 (K843150)Em Diagnostic Systems, Inc.1984-08-27
UREA ASSAY KIT (K843057)Diagnostic Chemicals, Ltd. (Usa)1984-08-27
EXTERNAL PEDIATRIC DEFIBRILLATOR PADDLE (K842667)Marquette Electronics, Inc.1984-08-27
ELECATH INFANT ARTERIAL & VENOUS CANNU (K842369)Electro-Catheter Corp.1984-08-27
LASER RECTOSCOPE SET 784 (K842997)Laser Industries , Ltd.1984-08-27
KEMBLE 405 (K842894)Kemble Instruments, Inc.1984-08-27
KODAK X-OMATIC RADIATION THERAPY CASS (K843176)Eastman Kodak Company1984-08-27
PROBE (K841624)Plastafil, Inc.1984-08-27
FLUID WARMER (K842302)Organon Teknika Corp.1984-08-27
THREADING TUBE (K841618)Plastafil, Inc.1984-08-27
SERVOCARD DEFIBRILLATOR SCP-851 (K842235)Litton Datamedix1984-08-27
MALLET (K841627)Plastafil, Inc.1984-08-27
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Every clearance here is in the API, with alerts when new ones post.