1978
1,975 FDA 510(k) clearances · Clearance year
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PRESSURE INFUSION CUFF (K781556) | Abbott Laboratories | 1978-10-17 |
| MAXIRAY 125 TUBE UNIT (K781524) | General Electric Co. | 1978-10-17 |
| EMIT PROCAINAMIDE ASSAY (K781382) | Syva Co. | 1978-10-17 |
| IDENTI-CLAMPS (K780721) | Berkeley Bio-Medical, Inc. | 1978-10-17 |
| MAXI-CAMERA 535 (K781673) | General Electric Co. | 1978-10-17 |
| SURGICAL LIGHT 22 SERIES (K781581) | American Sterilizer Co. | 1978-10-17 |
| ECG ELECTRODE, 2021, 2022, 2032, 2033 (K781514) | Cardio-Dynamics Laboratories, Inc. | 1978-10-17 |
| DIALYZER, DISP., COIL, LUNDIA (K781102) | Gambro, Inc. | 1978-10-17 |
| I-ESTRIOL TEST SET (K781599) | Wien Laboratories, Inc. | 1978-10-17 |
| DISPOSABLE INCENTIVE SPIROMETER (K781394) | Inhal-O-Tech Medical Plastic | 1978-10-16 |
| PATIENT CIRCUIT MANIFOLD (K781485) | Bourns Medical Systems, Inc. | 1978-10-16 |
| NEBULIZER/HUMIDIFIER MODEL EH 147B (K781591) | Mistogen Equipment Co. | 1978-10-16 |
| OXYGEN CONCENTRATOR (K781300) | Bendix Instruments & Life Support Div | 1978-10-16 |
| MONITOR, HEART RATE (K781166) | Cybernetic Medical, Inc. | 1978-10-15 |
| METER, FLOW, PEAK (K781224) | Projects IN Health | 1978-10-15 |
| NURITE II, SINGLE (K781683) | Bio-Medical Systems Corp. | 1978-10-13 |
| MONITOR, PO2, INTRAVASCULAR (K781271) | Roche Medical Electronics, Inc. | 1978-10-12 |
| RAD-291 (K781554) | Organon, Inc. | 1978-10-11 |
| PERFIT DENTAL RESTORATIVE COMPOSITE (K781580) | Locite Corp. | 1978-10-11 |
| NASOSTAT (K781615) | Nasostat, Inc. | 1978-10-11 |
| EARLY PREGNANCY DETECTION KIT (K781487) | Radioassay Systems Laboratories, Inc. | 1978-10-11 |
| C.P.R. COUNTING PACER (K781636) | Qual-Tec, Inc. | 1978-10-11 |
| ELECTRICAL NERVE STIMULATOR MODEL 6035 (K781565) | Stimulation Technology, Inc. | 1978-10-11 |
| OSCILLATING KNIFE AND ACCESSORIES (K781412) | Codman & Shurtleff, Inc. | 1978-10-11 |
| HEATED NEBULIZER (K781542) | Chemetron Medical Products, Inc. | 1978-10-10 |
| ECHO-OIL (K781631) | Echo Laboratories, Inc. | 1978-10-10 |
| BCG ALBUMIN REAGET (K781441) | Analytical & Research Chemicals, Inc. | 1978-10-10 |
| PAPILLOTOME CUTTING SNARE (K781353) | Cameron-Miller, Inc. | 1978-10-10 |
| CDC ANAEROBE BLOOD AGAR (K781604) | Anaerobe Systems | 1978-10-10 |
| TEKNI-CAL (K781601) | Streck Laboratories, Inc. | 1978-10-10 |
| CDC ANAEROBE BLOOD AGAR W/PHENETHYLALCH. (K781603) | Anaerobe Systems | 1978-10-10 |
| HEMATOXYLIN STAIN HARRIS (K781585) | Bioscientific | 1978-10-10 |
| R&R ABSORBENT POINTS (K781605) | Ransom and Randolph | 1978-10-10 |
| SURGITEK DISPOSABLE FLO-RESTER (K781336) | Medical Engineering Corp. | 1978-10-10 |
| PAPANICOLAOU STAIN EA-36 (K781582) | Bioscientific | 1978-10-10 |
| HEAT EXCHANGER, FHX-14 (K781210) | Delta Medical Industries | 1978-10-10 |
| PRESSURE MONITORING INJECTION LINES (K781558) | Cobe Laboratories, Inc. | 1978-10-10 |
| EPILATOR, EASE-MULTI-MODE (K781147) | Greenleaf-Carter Enterprises, Inc. | 1978-10-10 |
| GRAM STAIN KIT (K781584) | Bioscientific | 1978-10-10 |
| PAPANICOLAOU STIAN OG-6 (K781588) | Bioscientific | 1978-10-10 |
| EMIT N-ACETYLPROCAINAMIDE ASSAY (K781378) | Syva Co. | 1978-10-10 |
| RIA QUANT B-HCG TEST KIT (K781578) | Mallinckrodt Critical Care | 1978-10-10 |
| RA-I (K781642) | Diasonics, Inc. | 1978-10-10 |
| HEMATOLOGY STAIN PACK (K781587) | Bioscientific | 1978-10-10 |
| EMIT METHATREXATE ASSAY (K781381) | Dade Behring, Inc. | 1978-10-10 |
| FUNGUS FIGHTER INSOLES (K780719) | Combe, Inc. | 1978-10-10 |
| NEBULIZER/HUMIDIFIER (K781537) | Chemetron Medical Products, Inc. | 1978-10-10 |
| CHLORIDE REAGENT (K781460) | Analytical & Research Chemicals, Inc. | 1978-10-10 |
| RUBBER DAM HOLDER (K781520) | Young Dental Manufacturing Co. 1, LLC | 1978-10-10 |
| PAPANICOLAOU STAIN :EA-50: (K781583) | Bioscientific | 1978-10-10 |
| TRANSCUTANEOUS OXYGEN PERFUSION MONITOR (K780458) | Narco Air-Shields | 1978-10-10 |
| HEARING AID, ITE MODULAR MODEL I, II, V (K781663) | Oticon Corp. | 1978-10-10 |
| CDC ANAEROBE BLOOD W/KANAMYAN/VANCOM. (K781602) | Anaerobe Systems | 1978-10-10 |
| PREGELLED DISPOSABLE ELECTRODE (K781518) | Vente Medical Products, Inc. | 1978-10-06 |
| MONITORING, PRESSURE KIT (K781680) | Pharmaseal Div., Baxter Healthcare Corp. | 1978-10-06 |
| PRINTER, DIGITAL (K781115) | Output, Inc. | 1978-10-06 |
| MODIFIED STERILE DISPOSABLE STOPCOCKS (K781579) | Cobe Laboratories, Inc. | 1978-10-05 |
| PEEP/CPAP VALVE (K781332) | Vickers America Medical Corp. | 1978-10-04 |
| ANTIBIOTIC NEPHELOMETER (K781644) | Biovation, Inc. | 1978-10-03 |
| ULTRASONIC THERAPY APPARATUS, 407 (K781317) | General Theraphysical, Inc. | 1978-10-03 |
| PARALLEL BLADE MARKER (K780991) | Nestor Engineering Associates, Inc. | 1978-10-03 |
| DEVIN-NESTOR SQUARE KNIFE (K780989) | Nestor Engineering Associates, Inc. | 1978-10-03 |
| DELTA TEST ASSAY, HDL CHLORESTEROL (K781436) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-10-03 |
| GENERATOR, PULSE, MODEL 5997 (K781252) | Medtronic Vascular | 1978-10-03 |
| BECKMAN ASTRA SYSTEM (K781442) | Beckman Instruments, Inc. | 1978-10-03 |
| ACID PHOSPHATASE DIAG. KIT (K781489) | Sclavo, Inc. | 1978-10-03 |
| AUTOMATED ENZYMATIC TRIGLYCERIDE REAGENT (K781466) | Fisher Scientific Co., LLC | 1978-10-03 |
| SPECIALTY SPONGES (K781420) | Ipco Corp. | 1978-10-03 |
| THERAPY APPAR. 422 INTERFERENTIAL (K781319) | General Theraphysical, Inc. | 1978-10-03 |
| MINI-KEM (K781576) | Coulter Electronics, Inc. | 1978-10-03 |
| PORTABLE X-RAY UNIT (K781590) | General X-Ray, Inc. | 1978-10-03 |
| MICRODILUTION GRAM-NEGATIVE ID. PANEL (K781368) | Cnr Labs | 1978-10-03 |
| SINGLE VIAL LDH-L TRIS (K781538) | Boehringer Mannheim Corp. | 1978-10-03 |
| MOTOR RISER TOLIT LIFT (K781614) | Motor Riser Chairs , Ltd. | 1978-10-03 |
| STAT ULTRA VIOLET LIQUID (K781432) | Beckman Instruments, Inc. | 1978-10-03 |
| ENZAC INCUBATOR (K781501) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-10-03 |
| SMA/GGT (K781533) | Technicon Instruments Corp. | 1978-10-03 |
| DYNATRON 406 ELECTROTHERAPY APPARATUS (K781318) | General Theraphysical, Inc. | 1978-10-03 |
| ACID FAST KIT (K781643) | Bioscientific | 1978-10-03 |
| THC DIRECT RIA KIT (K781048) | Immunalysis Corporation | 1978-10-03 |
| MUSCLE STIMULATION APPARATUS (K781315) | General Theraphysical, Inc. | 1978-10-03 |
| GENERATORS, PULSE, MODELS 5988/5989 (K781208) | Medtronic Vascular | 1978-10-03 |
| CHLORIDE TEST SET, CAT.# 0210 (K781635) | Stanbio Laboratory | 1978-10-03 |
| MICRODILUTION STREP ID. PANEL (K781367) | Cnr Labs | 1978-10-03 |
| FOCISCAN ECHOVISOR SYSTEM (K781348) | Metrix Teknika, Inc. | 1978-10-03 |
| THERAPY UNIT & ELECTRODIAG. (K781314) | General Theraphysical, Inc. | 1978-10-03 |
| STAINLESS STEEL TEMPLATE (K780990) | Nestor Engineering Associates, Inc. | 1978-10-03 |
| LIFTING CHAIR & LIFTING LAVATORY SEAT (K781559) | Motor Riser Chairs , Ltd. | 1978-10-03 |
| EPPENDORF PCP 6121 (K781544) | Marilyn L. Amick | 1978-10-03 |
| DEVIN-NESTOR PNEUMATIC TOURNIQUET (K780988) | Nestor Engineering Associates, Inc. | 1978-10-03 |
| MEPA-1 BLOOD ANALYZER (K781606) | Medico Electronic, Inc. | 1978-10-03 |
| VISUALAX (K781634) | Farrall Instruments, Inc. | 1978-10-03 |
| SIREMAT (K781613) | Siemens Corp. | 1978-10-03 |
| ARCOBIOLITH PACEMAKER MODEL (K780776) | Arco Medical Products Co. | 1978-10-03 |
| RIA SYSTEM FOR HUMAN FE-RITIN (K781527) | Calbiochem-Behring Corp. | 1978-10-03 |
| MICRODILUTION ANAEROBE ID. PANEL (K781369) | Cnr Labs | 1978-10-03 |
| TRIGLYCERIDES TEST KIT (K781477) | Mallinckrodt Critical Care | 1978-10-03 |
| MODEL LS-80 ADULT VENTILATION MONITOR (K781515) | Bourns Medical Systems, Inc. | 1978-10-02 |
| LIQUID CRYSTAL THERMOGRAPHIC SYSTEM (K780478) | Thermal Imagery, Inc. | 1978-10-02 |
| BIO-PRO UNIT (K781303) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-10-02 |
Track 1978 automatically
Every clearance here is in the API, with alerts when new ones post.