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 |
|---|---|---|
| DISSCAP (K781142) | Hospal Medical Corp. | 1978-09-14 |
| HEMAC LASER HEMATOLOGY SYSTEM (K781146) | Ortho Instruments | 1978-09-14 |
| STANDARDIZE TGCL & TGCH (K781376) | American Monitor Corp. | 1978-09-14 |
| XIMATRON IV (K781496) | Siemens Elema AB | 1978-09-14 |
| UROSKOP A AND B (K781532) | Siemens Corp. | 1978-09-14 |
| EM-V (K781397) | Biological Corp. of America | 1978-09-14 |
| OPTI 110/12/50 HSG (K781540) | Siemens Corp. | 1978-09-14 |
| HEARING AID, UNITRON MODEL 960PL (K781513) | Unitron Industries, Inc. | 1978-09-14 |
| CAMERAS, MULTI-IMAGE (K781214) | Dunn Instruments, Inc. | 1978-09-14 |
| DENTAL X-RAY UNIT (K781286) | Siemens Corp. | 1978-09-11 |
| FLEXTUBES:9, 20, 26 (K781428) | Bourns Medical Systems, Inc. | 1978-09-11 |
| BUCKY WALL STAND (K781473) | Philips Medical Systems (Cleveland), Inc. | 1978-09-11 |
| DENTAL X-RAY UNIT W/CEPHALOMETRIC ATTACH (K781287) | Siemens Corp. | 1978-09-11 |
| HEARING AID, UNITRON MODEL 761P (K781502) | Unitron Industries, Inc. | 1978-09-11 |
| TUBING, FLEXIBLE, MEDICAL GAS (K781416) | Vitalab Products Corp. | 1978-09-11 |
| DENTAL X-RAY UNIT HELIODENT 70 (K781288) | Siemens Corp. | 1978-09-11 |
| OXYGEN SUPPLY TUBE, DISP., PLASTIC (K781231) | Rtec | 1978-09-11 |
| CAP-MOBILE (K781425) | Philips Medical Systems (Cleveland), Inc. | 1978-09-11 |
| SERIES 7000 GAS MACHINE (K781492) | Narco Mckesson Co. | 1978-09-11 |
| RADIOEAR RE SERIES HEARING AIDS (K781458) | Radioear Corp. | 1978-09-07 |
| MODEL 80100A, PATIENT DATA MEMORY (K781360) | Hewlett-Packard Co. | 1978-09-07 |
| CYTOLOGY BRUSH (K780872) | CooperVision, Inc. | 1978-09-07 |
| DOBBHOFF ENTERIC FEEDING BAG (K781385) | Biosearch Medical Products, Inc. | 1978-09-07 |
| AUTOREFRACTOR, SUBJECTIVE (K781014) | Cavitron Corp. | 1978-09-07 |
| DINAMAP MODEL 848 (K781064) | Applied Medical Research | 1978-09-07 |
| CARDIAL PULSE GENERATORS (K781426) | Telectronics, Inc. | 1978-09-07 |
| FLUORESCENT ANTI-NATIVE DNA TEST (K780899) | Kallestad Laboratories, Inc. | 1978-09-07 |
| MASK, PXYGEN (K781413) | Vitalab Products Corp. | 1978-09-07 |
| PREAMPLIFIER MODELS 8101PI & 8102PI (K781474) | Life-Tech Instruments, Inc. | 1978-09-07 |
| PATIENT AID, MODEL DM-351 (K781176) | Extracorporeal Medical Specialities, Inc. | 1978-09-07 |
| ELECTRIC CT/T OPERATOR DISPLAY CONSOLE (K781431) | General Electric Co. | 1978-09-07 |
| DINAMAP MODEL 846 (K781053) | Applied Medical Research | 1978-09-07 |
| CUTTER RESIFLEX FOLEY CATHETERS (K781140) | Cutler Laboratories, Inc. | 1978-09-07 |
| GAVAGE ADMIN. SET (K781230) | Mcgaw Laboratories | 1978-09-07 |
| KWIK-FLO URINAL SYSTEM (K781422) | The Grace Mfg. Co. | 1978-09-07 |
| PENLIGHTS (K781228) | Abco Dealers, Inc. | 1978-09-07 |
| HYDRON BURN BANDAGE MANUAL APPLICATION (K781406) | Abbott Laboratories | 1978-09-07 |
| MODESS* BELTLESS FEMININE NAPKIN (K781470) | Personal Products Co. | 1978-09-07 |
| BED PADS: D-12 AND D-8 (K781404) | Grant Airmass Corp. | 1978-09-07 |
| U-FLOAT VALVE 2D9023 (K781467) | Travenol Laboratories, S.A. | 1978-09-07 |
| LENSOMETER MODEL 11 (K781440) | Rodenstock Instrument Corp. | 1978-09-07 |
| ELECTRODE IMPEDANCE TESTER-MODEL 500 (K781475) | Life-Tech Instruments, Inc. | 1978-09-07 |
| CONTINUOUS FEED VALVE 2D9024 (K781468) | Travenol Laboratories, S.A. | 1978-09-07 |
| GENERATOR, CARDIAC PULSE, 250B (K781090) | Telectronics, Inc. | 1978-09-07 |
| PULSE GENERATOR MODEL 208 (K781178) | Elema-Schonander, Inc. | 1978-09-07 |
| MASK, OXYGEN, NONBREATHING (K781414) | Vitalab Products Corp. | 1978-09-07 |
| LUMBAR NERVE ROOT SHIELD (K780706) | Heyer Schulte Corp. | 1978-09-07 |
| CANNULA, NASAL, OXYGEN (K781415) | Vitalab Products Corp. | 1978-09-07 |
| SYSTEM 6000 AUTOMATED RIA ANALYZER (K780886) | Beckman Instruments, Inc. | 1978-09-01 |
| BJORK-SHILEY CARDIAC HEART VALVE (K780772) | Shiley, Inc. | 1978-09-01 |
| MYCOPLASMA HYORHINIS (BTS-7) (K781390) | Flow Laboratories, Inc. | 1978-09-01 |
| IMAGE (K781169) | Deringer-Ney, Inc. | 1978-08-31 |
| THREADED PIN, SELF DRILLING (K781251) | Ace Orthopedic Manufacturing Co. | 1978-08-31 |
| LEAD CONVERSION KIT, MODEL 341 (K781111) | Edwards Pacemaker Systems | 1978-08-31 |
| HUMAN CHORIONIC GONADO.-BETA RIA KIT (K781310) | Diagnostics Biochem Canada, Inc. | 1978-08-31 |
| XOMED TRANSSPHENOIDAL HANDPIECE (K781418) | Xomed, Inc. | 1978-08-31 |
| TEST MODULE MODEL DM-352 (K781215) | Extracorporeal Medical Specialities, Inc. | 1978-08-31 |
| GLOBULIN TEST, HUMAN THYROXINE BINDING (K781225) | Hyland Therapeutic Div., Travenol Laboratories | 1978-08-31 |
| GENERATOR, PULSE, PACEMAKER (K781168) | Vitatron Medical BV | 1978-08-31 |
| OXYGEN RICH AIR SUPPLY UNIT-MODEL 390 (K781074) | Xorbox | 1978-08-31 |
| U-DRAPE, BOUNDARY (K781172) | Procter & Gamble Mfg. Co. | 1978-08-31 |
| LDH PROCEDURE (K781323) | Analytical & Research Chemicals, Inc. | 1978-08-31 |
| KIDNEY, ARTIFICIAL, C-DAK 2.0 (K781237) | Cordis Corp. | 1978-08-31 |
| HAND-TROL CONNECTOR EXTENDER (K781429) | Aspen Laboratories, Inc. | 1978-08-31 |
| STERILE URETHRAL CATHETER KIT (K760897) | Diamed Division Ill. Tool Works, Inc. | 1978-08-31 |
| ECON-O2 (K781219) | Mountain Medical Equipment, Inc. | 1978-08-31 |
| DENTAL SILICONE IMPRESSION MATERIAL (K781083) | Crown Delta Corp. | 1978-08-31 |
| ACCESSORY TO 4-24 RECORDER (K781129) | Oxford Medilog, Inc. | 1978-08-31 |
| TEMP. CROWN MSTERIAL FOR TEETH (K781244) | Den-Mat Corp. | 1978-08-31 |
| PACER-TRACER PULSE WIDTH (K781349) | Instromedix, Inc. | 1978-08-31 |
| MODEL 1861 BLOOD PUMP (K780953) | Medtronic Vascular | 1978-08-31 |
| BLOOD LEVEL DETECTOR-MODEL 7601 (K781330) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-08-31 |
| HEARING AID, UNITRON MODEL 958 (K781439) | Unitron Industries, Inc. | 1978-08-31 |
| ULTRAFILL- ULTRABOUND (K781345) | Demetron Research Corp. | 1978-08-31 |
| ELECTROCARDIOGRAPHIC ECG RECORDER (K781152) | Cardio-Dynamics Laboratories, Inc. | 1978-08-31 |
| ENTEROTUBE II (K781236) | Hoffmann-La Roche, Inc. | 1978-08-31 |
| MODEL 20 DIGITAL PULSE RATE MONITOR (K780937) | Sentronix, Inc. | 1978-08-31 |
| REPROSIL (K781151) | Dentsply Intl. | 1978-08-31 |
| GLUCOLOUR (K781308) | Analytical & Research Chemicals, Inc. | 1978-08-31 |
| RABBIT ANTIBODY TO HUMAN T3 (K781284) | Pcl-Ria, Inc. | 1978-08-31 |
| ALP TEST (K781324) | Analytical & Research Chemicals, Inc. | 1978-08-31 |
| HEARING AID, UNITRON MODEL 975 (K781434) | Unitron Industries, Inc. | 1978-08-31 |
| GLOVES, PROCEDURE (K781278) | Arbrook Mfg. Corp. | 1978-08-31 |
| THYRO-SHURE (K781296) | Nuclear Medical Laboratories, Inc. | 1978-08-31 |
| GOT PROCEDURE (K781309) | Analytical & Research Chemicals, Inc. | 1978-08-31 |
| UREA NITROGEN (K781305) | Analytical & Research Chemicals, Inc. | 1978-08-31 |
| MODEL 80 CONDUCTIVITY/TEMP.TEST UNIT (K780932) | Western Laboratories Corp. | 1978-08-31 |
| DISPOSABLE AEROSOL T BRIGGS ADAPTOR (K781395) | Inhal-O-Tech Medical Plastic | 1978-08-31 |
| UREA NITROGEN TEST KIT (K781306) | Analytical & Research Chemicals, Inc. | 1978-08-31 |
| GLUCOSE TEST (K781342) | Wako Intl., Inc. | 1978-08-31 |
| LIPOPROTEIN STAIN (K781122) | Electrophoresis Corp. of America | 1978-08-31 |
| KIDNEY, ARTIFICIAL, C-DAK 1.5 (K781238) | Cordis Corp. | 1978-08-31 |
| PACEMAKER, ELECTRODE, PERMANENT & TEMP. (K780246) | Daig Corp. | 1978-08-31 |
| MICROCULT-GC CULTURE TEST (K781108) | Miles Laboratories, Inc. | 1978-08-31 |
| DUAL COMPONENT STANDARDS (K781423) | Abbott Laboratories | 1978-08-31 |
| DIGOXIN RIA (PEG) KIT (K781335) | Ortho Diagnostics, Inc. | 1978-08-31 |
| GLUCOSE DETERM. KIT (K781307) | Analytical & Research Chemicals, Inc. | 1978-08-31 |
| ELECTROSURGICAL PENCIL SYSTEM (K781148) | Medical Plastics, Inc. | 1978-08-31 |
| IMMUNOCHEMISTRY SYS. MANUAL MODE (K781006) | Beckman Instruments, Inc. | 1978-08-31 |
| ICS NORMAL CONTROL SERUM (K781355) | Beckman Instruments, Inc. | 1978-08-31 |
Track 1978 automatically
Every clearance here is in the API, with alerts when new ones post.