Atlas FDA

1978

1,975 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MODEL 5621A INTERFACE (K780768)Hewlett-Packard Co.1978-05-26
EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE (K780762)Shiley, Inc.1978-05-26
SONOGRAF EDP REAL-TIME ADAPTER (K780578)Foley, Lardner, Hollabaugh & Jacobs1978-05-25
GYNESURG (K780587)Polamedco, Inc.1978-05-25
HEMATOLOGY SLIDE STAINER (K780637)A. J. P. Scientific, Inc.1978-05-19
REAGENT SET HDL CHOLESTEROL (K780635)Boehringer Mannheim Corp.1978-05-19
ECONO-FLOAT WATER FLOTATION MATTRESS (K780779)Jefferson Industries, Inc.1978-05-19
ELECTRODE TESTER (K780501)Mg Medical Electronics1978-05-19
ULTRACHEM ENZYMATIC CHOLESTEROL 65025 (K780523)Harleco1978-05-19
ULTRACHEM T-BILI 64971 GILFORD 3500 (K780524)Harleco1978-05-19
SUTURELESS MYOCARDIAL PACING LEAD (K780446)Medtronic Vascular1978-05-19
COMP. CLIN. CHEM. CONTROL SERUM-DECISION (K780552)Beckman Instruments, Inc.1978-05-19
ULTRACHEM E-GLU, 300 SERIES CENTRIFUCHEM (K780515)Harleco1978-05-19
AIRWAYS (K780601)Abco Dealers, Inc.1978-05-19
UREA NITROGEN (ENZYMATIC) (K780534)Macomb Chemical Co.1978-05-19
SUBCUPASS TUNNELING TOOL (K780579)Medtronic Vascular1978-05-19
CARDIAC MINISCOPE & MINIGRAPH (K780297)Arco Medical Products Co.1978-05-19
T-3 UPTAKE (SORBENT) KIT (K780525)Amersham Corp.1978-05-19
PLATELETS/CU MM (K780577)Geometric Data, Div. Smithkline Corp.1978-05-19
RP-510/RP-514 PARALLEL PLATE DIALYZERS (K780427)Hospal Medical Corp.1978-05-19
INFUSION PUMP-MODEL 2616 (K780705)Harvard Apparatus, Inc.1978-05-19
NEUROLOGICAL SCREENING STIMULATOR M 3623 (K780758)Medtronic Vascular1978-05-19
125-I LABELED HUMAN LUTEINIZING HORMONE (K780576)Pcl-Ria, Inc.1978-05-19
ALFATEST (K780542)Panmed, Inc.1978-05-19
MICROCELL COUNTER MODEL CC-108 (K780224)Toa Medical Electronics USA, Inc.1978-05-19
ULTRA ZYME PLUS AMYL 64982, GILFORD 3500 (K780513)Harleco1978-05-19
CARDIAC MINIGRAPH (K780307)Arco Medical Products Co.1978-05-19
PRESSURE MODULES MODELS 1855 & 1856 (K780541)Life-Tech Instruments, Inc.1978-05-19
COMP. CLIN. CHEM. REF. SERUM-BENCHMARK (K780553)Beckman Instruments, Inc.1978-05-19
ULTRACHEM CREATININE 64972, CENTRIFUCHEM (K780514)Harleco1978-05-19
MODEL 902 STAND (K780759)Applied Medical Research1978-05-19
CSS-60 DIGITAL HEART RATE METER (K780702)Burdick Corp.1978-05-19
EPILATION TYPE DEVICE (K780348)Mehl, Thomas L.1978-05-18
FOLATE REAGENT KIT, ARIA-II SYSTEM (K780557)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-05-18
SINGLE VIAL 10 SGOT-TRIS (K780634)Boehringer Mannheim Corp.1978-05-18
SINGLE VIAL 10 SGPT-TRIS (K780636)Boehringer Mannheim Corp.1978-05-18
LAS-R HUMAN COMPLEMENT CLQ TEST (K780729)Hyland Therapeutic Div., Travenol Laboratories1978-05-18
GENERATORS, ATRIAL INHIBITED PULSE (K780327)Medtronic Vascular1978-05-18
SOFT LENS REMOVER/INSERTER/MANIPULATOR (K780664)Dmv Contact Lens Co.1978-05-17
CONTACT LENS REMOVER AND INSERTER (K780663)Dmv Contact Lens Co.1978-05-17
4600 RECORDER (K780677)G & W Applied Science Laboratories1978-05-17
KERR DISCOVERY DISPOSABLE FLUORIDE TRAY (K780712)Kerr Corporation (Danbury)1978-05-17
SPEECH AUDIOMETER RA 226 (K780749)Tracor Instruments, Inc.1978-05-16
MICROCLIP, WILLIAMS (K780586)Richard'S Medical Equip., Inc.1978-05-16
ILEX STOMA SEAL AND PROTECTIVE CREAM (K780473)Virgil Pichierri1978-05-16
BETA CAP SYSTEM (K780449)Quinton, Inc.1978-05-16
VAS APPROXIMATOR (K780520)Edward Weck, Inc.1978-05-16
PULMONARY FUNCTION TESTER (K780584)Warren E. Collins, Inc.1978-05-16
DENTAL OFFICE ENVIRONMENT CONTROL UNIT (K780701)Laminaire Corp.1978-05-16
CENTRAL CATHETER KIT (K780673)Argon Medical Corp.1978-05-16
RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE (K780385)Travenol Laboratories, S.A.1978-05-16
MICRO RASPS (K780771)Amsco Co.1978-05-16
ENTRAX TRACTION UNIT (K780763)Orthopedic Equipment Co., Inc.1978-05-16
RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE (K780381)Travenol Laboratories, S.A.1978-05-16
BAGS, PLASTIC, STERILE FOR GENERATORS (K780777)Telectronics, Inc.1978-05-16
HYGIENIC RUBBER DAM FRAME (K780746)Hygienic Dental Mfg., Co., The1978-05-12
HEARING AID BATTERY CHARGER (K780694)Cahill Enterprises, Inc.1978-05-12
FOME-CUF PVC (K780583)Bivona Medical Technologies1978-05-12
CULTURE SWAB (K780713)Royal Scientific, Inc.1978-05-12
SPECTROPHOTOMETERS, ATOMIC ABSORPTION (K780522)Instrumentation Laboratory CO1978-05-12
SPECTROPHOTOMETER, ATOMIC ABSORPTION (K780521)Instrumentation Laboratory CO1978-05-12
CLAMP FORCEPS (K780743)Hygienic Dental Mfg., Co., The1978-05-12
IN VITRO GENTAMICIN RADIOIMMUNOASSY TEST (K780709)Clinical Assays, Inc.1978-05-12
DATA-ZYME TRIGLYCERIDE PROCEDURE (K780379)Data Medical Associates, Inc.1978-05-12
SHORTWAVE DIATHERMY MODEL 802 (K780755)Birtcher Corp.1978-05-12
AST(GOT) UNI-UV, SGOT (K780463)Sclavo, Inc.1978-05-12
TOTAL HIP, LORD MADREPORIC (K780330)Howmedica Corp.1978-05-12
COLUMBIA AGAR WITH 5% RABBIT BLOOD (K780704)Granite Diagnostics, Inc.1978-05-12
RELAX-A-TONE (K780436)Bio Response1978-05-12
RUBBER DAM (K780745)Hygienic Dental Mfg., Co., The1978-05-12
STIMULATORS, NERVE, ELECTRICAL (K780698)Med General1978-05-12
BRINKER TISSUE RETRACTORS (K780744)Hygienic Dental Mfg., Co., The1978-05-12
POWER STRIDER (K780402)Seidel Manufacturing, Inc.1978-05-12
ALT(GPT) UNI-UV, SGPT (K780462)Sclavo, Inc.1978-05-12
ULTRASONIC DIAGNOSTIC TRANSDUCER (K780651)Hoffrel Instruments, Inc.1978-05-09
SHOE COVERS (K780590)Abco Dealers, Inc.1978-05-09
DCG PREAMPLIFIER MODULE (K780572)C-V Monitors Corp.1978-05-09
STERILE 100% SILICONE FOLEY CATHETER (K780675)Medline Industries, Inc.1978-05-09
MYOCATH KIT (K780529)Sorensen Research1978-05-09
AIR MASSAGE SYSTEM (K780710)Theracom C/O Arent, Fox, Kintner, Plotki1978-05-09
CARROLL TENDON RETRIEVER (K772393)Edward Weck, Inc.1978-05-09
PHOTOCOAGULATOR LASER (K780345)Cavitron Corp.1978-05-09
ISOLATION GOWN (K780605)Abco Dealers, Inc.1978-05-09
FILTER TUBE (K780519)Jelco Laboratories1978-05-09
OTOSCOPE SPECULA (K780723)Abco Dealers, Inc.1978-05-09
RYUSEI (K772424)Ercona Corp.1978-05-09
STERILE CLOSED SYSTEM (K780676)Medline Industries, Inc.1978-05-09
BLOOD PRESSURE MODULE (K780571)C-V Monitors Corp.1978-05-09
FIGURETRIM (K780730)Jay-Mar INternational Enterprises, IN1978-05-09
FETAL MONITORING SYSTEM (K780487)Sonicaid, Inc.1978-05-09
CBR-T3RIA KIT (K780499)Clinical Bioresearch1978-05-04
BLOOD CULTURE MEDIA (K780615)Meda Stat Diagnostics, Inc.1978-05-04
CRE. PHOSPHOKINASE ISOENZYMES, REA. SYS. (K780372)Abbott Laboratories1978-05-03
SERUM GLUTAMIC-PYRUVIC TRANSAMINASE (K780507)Gamma Enterprises, Inc.1978-05-03
LITECAST SOLDER (K780642)Williams Gold Refining Co., Inc.1978-05-03
HEMO FEC (K780214)Boehringer Mannheim Corp.1978-05-03
BLOOD PUMP-MODE S10K (K780410)3M Health Care, Sarns1978-05-03
AUTO/STAT KIT (K780512)Pierce Chemical Co.1978-05-03
NDM INFANT ECG PACKPAD (K780631)New Dimensions IN Medicine, Inc.1978-05-03
SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE (K780505)Gamma Enterprises, Inc.1978-05-03
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Every clearance here is in the API, with alerts when new ones post.