Atlas FDA

1978

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

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RecordFirmDate
KAPPA SERUM (FREE & BOUND) ANTI-HUMAN (K781028)Icl Scientific1978-07-27
CALCIUM REAGENT SYSTEM NO. 585 (K780983)Sigma Chemical Co.1978-07-27
BACILLUS PUMILUS (K780974)Urol, Inc.1978-07-27
PROLITH 23S PACEMAKER (K781042)Edwards Pacemaker Systems1978-07-27
HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2 (K780652)The London Co.1978-07-27
(AST) OR (ALT) UV DETERM. PHY. PHOS. (K781020)The Dow Chemical Co.1978-07-27
WRENCH, GEXAGON, DRIVER (K781179)Telectronics, Inc.1978-07-27
CONTROL, HEMATOLOGY, CH-60 (K781077)Dade, Baxter Travenol Diagnostics, Inc.1978-07-27
RIA TSH IN HUMAN SERUM OR PLASMA (K781150)Diagnostic Corp. of America1978-07-27
ANEMOMETER, NASAL, EXETER (K781218)Medika Corp.1978-07-27
PVC LINES FOR MONITORING (K780985)Norton Performance Plastics Corp.1978-07-27
BUN TEST UNI-UV BLOOD UREA NITROGEN TEST (K780943)Sclavo, Inc.1978-07-27
VENTRICULAR INHIBITED PULSE GENERATOR (K780561)Medtronic Vascular1978-07-27
LAMBDA SERUM (FREE) ANTI-HUMAN (K781025)Icl Scientific1978-07-27
RIA TEST KIT SYS. DAMON KIQUISOL FREE (K781012)Damon Corp.1978-07-27
TRANSPORT INCUBATOR (K780964)Cavitron Corp.1978-07-27
SIGNAPAD (K780973)Parker Laboratories, Inc.1978-07-27
OXYGENATOR, BLOOD, INFANT/PEDIATRIC (K781223)Shiley, Inc.1978-07-27
PLATELET CONTROL (K780980)Bhp Diagnostix, Inc.1978-07-27
COMPRESSOR, AIR, MINI-SILENT (K781213)The John Bunn Co.1978-07-27
PRINCETON BIOMEDIX URICASE (UV) (K780859)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-07-27
ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER (K780946)Hycel, Inc.1978-07-27
PREP I AUTOMATED SAMPLE PROCESSOR (K780933)E.I. Dupont DE Nemours & Co., Inc.1978-07-27
PAPILLOTOMY KNIVES (K780774)Olympus Corp.1978-07-27
SCALPEL (K780998)Isolab, Inc.1978-07-27
STILITH CARDIAC PACEMAKERS-M. 60 & 120 (K780781)R.E. Brown Co., Inc.1978-07-27
IN VITRO NEONATAL T4 (K780854)Clinical Assays, Inc.1978-07-27
CONDUCTIVE CUSHION (K780941)Markham Service Co., Inc.1978-07-27
BURETTE SET WITH AIR CONTROL LEVER (K780970)Travenol Laboratories, S.A.1978-07-27
GLOBIN-TERGE (K780817)Simmler & Son, Inc.1978-07-27
LIFELINE AMBULATORY (K781054)Imc1978-07-27
ANALYZER, SERUM IRON & TOTAL IRON BINDIN (K781009)Environmental Sciences Assoc., Inc.1978-07-27
URINARY DRAINAGE BAG (K780837)Intermed, Inc.1978-07-27
CHOLESTEROL & HDL CHOL. PROCEDURE (K781165)Data Medical Associates, Inc.1978-07-27
AUTOMATED ENZYME (K780962)Hyland Therapeutic Div., Travenol Laboratories1978-07-27
AEROPLAST DRESSING (K781031)Parke-Davis Co.1978-07-27
A-33 DENTAL ALLOY (K781045)Howmedica Corp.1978-07-27
ANTI-HUMAN LAMBDA SERUM (K781220)Icl Scientific1978-07-27
IRRIGATION CAP (K780794)Travenol Laboratories, S.A.1978-07-27
O2 CONNECTOR (K780750)Diemolding Corp.1978-07-27
HMA URIC ACID TEST (K781004)Hycel, Inc.1978-07-27
LEAD, PACING, ATRIAL, ENDOCARDIAL, TINED (K780621)Medtronic Vascular1978-07-26
STERILE INFUSION SET TYPE S (K780655)Suru Chemicals & Pharmaceuticals, Ltd.1978-07-19
STERILE INFUSION SET TYPE J (K780656)Suru Chemicals & Pharmaceuticals, Ltd.1978-07-19
STERILE BLOOD COLLECTION SET (K780657)Suru Chemicals & Pharmaceuticals, Ltd.1978-07-19
SURGICAL LASER (K780585)Laser Industries , Ltd.1978-07-19
STERILE BLOOD ADMINISTRATION SET (K780658)Suru Chemicals & Pharmaceuticals, Ltd.1978-07-19
THERAPAX 150A (K781084)Emi Therapy Systems, Inc.1978-07-18
CT SCANNER ND 8000 (K781040)Cgr Medical Corp.1978-07-18
DIGITAL BLOOD PRESSURE MONITOR (K780986)Sears, Roebuck & Co.1978-07-18
LUNDIA PLATE DISPOSABLE DIALYZER (K780700)Gambro, Inc.1978-07-17
AUTOMATIC RETRACTOR HOLDER (K780708)Great Eastern Lumber Co., Inc.1978-07-17
PERCI (K780838)Micro Tronics Corp.1978-07-17
FACE TENTS (K781055)Hospitak, Inc.1978-07-17
KNEE INSTRUMENTATION, CONDYLAR (K781091)Biomet, Inc.1978-07-17
HEARING AID, EYEGLASS (K781094)Argosy Intl. (Usa), Inc.1978-07-17
PENTAX ST-1A (K780738)Hal-Hen Co., Inc.1978-07-17
PLURIX C; RADIOGRAPHIC TABLE (K781066)Tecnomed, Inc.1978-07-17
AUTOMATIC FILM PROCESSORIO M. R80 (K781068)Tecnomed, Inc.1978-07-17
CLINAC 20 (OPTIONAL 18 MV VERSION) (K781057)Varian Assoc., Inc.1978-07-17
CAST WEDGE, YANCEY (K781112)Orthopedic Equipment Co., Inc.1978-07-17
CUFF PACER (K780703)Omp Laboratories, Inc.1978-07-17
ASSURE NATURAL FIT TAMPON (K781085)Personal Products Co.1978-07-17
PLURIMAT;RADIOGRAPHIC TUBE MOUNT (K781065)Tecnomed, Inc.1978-07-17
ELECTROSURGICAL UNIT 75 (K781101)Ritter Co.1978-07-17
SONOGRAF ULTRASOUND B-SCANNING SYSTEM (K781079)Ohio Nuclear, Inc.1978-07-17
BARD-PARKER ARTERIAL MONITORING SYSTEM (K780939)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-07-17
EMISONIC 4201 (K781051)Emi Medical, Inc.1978-07-17
SLICK SET (K780900)Polamedco, Inc.1978-07-17
HEARING AID, EYEGLASS, B-12 (K781096)Argosy Intl. (Usa), Inc.1978-07-17
PVC QUICK PRIME LINES (K780984)Norton Performance Plastics Corp.1978-07-17
SILASTIC BRAND PENILE IMPLANT (K780484)Dow Corning Corp. Healthcare Industries Materials1978-07-17
ANEROID TYPE BLOOD PRESSURE KIT (K780715)Mars Metal Co., Ltd.1978-07-17
SUTURE CUTTER (K780574)Laschal Instrument Corp.1978-07-17
PLURIX B; RADIOGRAPHIC TABLE (K781067)Tecnomed, Inc.1978-07-17
X-RAY UNIT, PORTABLE GX-101 AEC (K781030)General X-Ray, Inc.1978-07-17
DISPENSER, GAS XENON (K781107)Mallinckrodt Critical Care1978-07-17
PERCUTANEOUS SURAPUBIC CATHETER (K780765)Vance Products, Inc.1978-07-17
HEARING AID, BEHIND THE EAR (K781095)Argosy Intl. (Usa), Inc.1978-07-17
ONE INCISION BI-POLAR ELECTRO. FORCEPS (K781089)Kli1978-07-17
GALVANATOR, MODEL 770 (K781080)Avra Corp.1978-07-07
GENERATOR, PULSE, CARDIAC, IMPLANTABLE (K780421)Telectronics, Inc.1978-07-07
SUTURELESS SKIN CLOSURE (K780565)Abbott Laboratories1978-07-07
CAST BLOCK (K781082)Orthopedic Equipment Co., Inc.1978-07-07
SET, ADMINISTRATION, MANUAL, DIALYSIS (K780957)American Medical Products, Inc.1978-07-06
CHARLES ENDOCOAGULATOR ACCESSORY FOR ARC (K780851)Varian Assoc., Inc.1978-06-30
SAFETY STOP NECKSTRAP (K780814)Northwest Orthodontics, Inc.1978-06-30
INSTANT CURE-1 (K780898)Ultra-Light Corp.1978-06-30
COTTON TIPPED POINT (K780929)Young Dental Manufacturing Co. 1, LLC1978-06-30
ULTRASONIC DENTAL PROPHYLAXIS UNIT,SSM (K781044)Litton Dental Products1978-06-30
ELECTRO-PLETHYSMOGRAPH (K780761)Biotecx Laboratories, Inc.1978-06-30
FECATEST (K780564)Otto C. Watzka1978-06-30
CHAIRS WITH CASTORS (K781001)Orthopedic Equipment Co., Inc.1978-06-30
MICROPULSE 22S PACEMAKER (K780780)Edwards Pacemaker Systems1978-06-30
CERVICAL COLLAR (K780994)Fox Instruments, Inc.1978-06-30
CONTACT LENS CLEANSER (K780823)Ketchum Laboratories, Inc.1978-06-30
AIRSTIRRUP PNEUMATIC ANKLE BRACE (K780979)Aircast, Inc.1978-06-30
EXTERNAL TEST PULSE GENERATOR (K780717)Vitatron Medical BV1978-06-30
PREMIER INLAY PLACER (K781034)Premier Dental Products Co.1978-06-30
Y-TYPE BLOOD SET (K780880)Abbott Laboratories1978-06-30
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Every clearance here is in the API, with alerts when new ones post.