1977
2,114 FDA 510(k) clearances · Clearance year
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| FIBER OPTICS PROCTOSCOPE (K771920) | Propper Mfg. Co., Inc. | 1977-10-20 |
| UNIOLITE (K771889) | Espe Dental Products | 1977-10-20 |
| FIBEO OPTICS ILLUM. SYSTEM (K771918) | Propper Mfg. Co., Inc. | 1977-10-20 |
| REPLICA ACID-ETCH (K771883) | Hoyt Laboratories | 1977-10-20 |
| CLINAC 6/100 (K771809) | Varian Assoc., Inc. | 1977-10-19 |
| AUTOMIXER, KODAK (K771857) | Eastman Kodak Company | 1977-10-19 |
| MEDPRO FLOTATION SYSTEM (K771824) | Medpro, Inc. | 1977-10-19 |
| ROCHE AXISCAN 5 (K771816) | Roche Medical Electronics, Inc. | 1977-10-19 |
| GLYCOPROTEIN TEST, LAS-R HUMAN 1-ACID (K771879) | Hyland Therapeutic Div., Travenol Laboratories | 1977-10-19 |
| BG II ANALYZER (K771822) | Technicon Instruments Corp. | 1977-10-19 |
| EMI FOUR (K771902) | Emi Therapy Systems, Inc. | 1977-10-19 |
| PROCEDURE NO. 555 (K771916) | Sigma Chemical Co. | 1977-10-19 |
| CARDIOZYME CK-CONTROL LEVEL 1 (K771740) | Dade, Baxter Travenol Diagnostics, Inc. | 1977-10-19 |
| JEMBEC-CVSB PLATE (K771647) | J.P. Kilbourn, Ph.D. | 1977-10-19 |
| EMI CTR 100 (K771811) | Emi Medical, Inc. | 1977-10-19 |
| ENZYMATIC CHOLESTEROL (K771820) | Macomb Chemical Co. | 1977-10-19 |
| LAS-R BETA LIPOPROTEIN TEST (K771912) | Hyland Therapeutic Div., Travenol Laboratories | 1977-10-19 |
| TOTAL BILIRUBIN (K771840) | Gamma Enterprises, Inc. | 1977-10-19 |
| CLINAC 4/100 (K771808) | Varian Assoc., Inc. | 1977-10-19 |
| DISP. LOADING UNIT, AUTO, SUTURE (K771178) | United States Surgical, A Division of Tyco Healthc | 1977-10-18 |
| TENCKHOFF PERITONEAL TUBING ADAPT. (K771428) | Quinton, Inc. | 1977-10-18 |
| STAT/LYTE ANALYZER (K771592) | Technicon Instruments Corp. | 1977-10-18 |
| RUBA-NOST TEST KITS (K771796) | Behring Diagnostics, Inc. | 1977-10-18 |
| FOLHY CATHETER (K771860) | Polysil, Inc. | 1977-10-18 |
| IFA ANTI-NDNA (K771376) | Electro-Nucleonics Laboratories, Inc. | 1977-10-18 |
| ALKALINE PHOSPHATASE TEST (K771695) | Sclavo, Inc. | 1977-10-18 |
| LIPPOPROTEIN ELECTROPHORESIS REAGENT SET (K771812) | Gelman Instrument Co. | 1977-10-18 |
| CATHETER, URETHERAL (K770814) | C.R. Bard, Inc. | 1977-10-18 |
| SURGICAL STAPLING INSTRU., AUTO, SUTURE (K771177) | United States Surgical, A Division of Tyco Healthc | 1977-10-18 |
| DERTRAN-COATED CHARCOAL TABLETS (K771704) | Reflex Industries, Inc. | 1977-10-18 |
| URI-DRAIN COMBO KIT FOR MALE INCONTINENC (K770789) | Chesebrough-Pond'S U.S.A. Co. | 1977-10-18 |
| FOLLICLE-STIMULATING HORMONE (K771756) | Nichols Institute Diagnostics | 1977-10-18 |
| ELECTROCARDIOGRAPHIC CABLHS & LEAD WIRE (K771645) | Tronomed, Inc. | 1977-10-18 |
| GLUCOSE REAGENT FOR GLUC. ANALYZER (K771754) | Harleco | 1977-10-18 |
| I.L. MODEL 643 FLAME PHOTOMETER (K771337) | Instrumentation Laboratory CO | 1977-10-18 |
| ENDOSCOPE, UROLOGICAL, FEMALE (K770943) | C.R. Bard, Inc. | 1977-10-18 |
| BARBITAL BUFFER (K771721) | Sigma Chemical Co. | 1977-10-18 |
| CHOLESTEROL (K771833) | Gamma Enterprises, Inc. | 1977-10-18 |
| TEK-CHEK-2 (K771713) | Miles Laboratories, Inc. | 1977-10-18 |
| TSH RIA REAGENT SET (K771234) | G.D. Searle and Co. | 1977-10-18 |
| NEO TSH-RIA KIT (K771378) | Nuclear Medical Systems, Inc. | 1977-10-18 |
| VAPOR 19 (K771899) | Draeger Medical, Inc. | 1977-10-18 |
| ELECTROPHORESIS POWER SUPPLY TESTER (K771322) | Corning Medical & Scientific | 1977-10-18 |
| AUTOMATED SLIDE SPINNER (K771898) | Dynatech Cryomedical Co. | 1977-10-18 |
| UROFLOW-CYSTOMETER SYSTEM (K771850) | Richard Wolf Medical Instruments Corp. | 1977-10-18 |
| HEMATRAK RBC MORPHOLOGY (K761207) | Geometric Data, Div. Smithkline Corp. | 1977-10-18 |
| 125 I DIGOXIN RIA KIT (K771525) | Diagnostic Products Corp. | 1977-10-14 |
| CLINICARD CREATININE CHEMISTRY (K771773) | Harleco | 1977-10-14 |
| CURITY PEAKOMETER (K771655) | Kendall Research Center | 1977-10-14 |
| PTH RIA (K771783) | Nichols Institute Diagnostics | 1977-10-14 |
| ID BRACLETS, ADULT & INFANT (K771158) | Divers-A-Med | 1977-10-13 |
| TRANSFUSION BLOOD FILTER (K771862) | Medical, Inc. | 1977-10-13 |
| BLOOD GAS TRAY #4024 (K771667) | Concord Laboratories, Inc. | 1977-10-13 |
| PERMAGUM ADHESIVE (K771853) | Espe GmbH (Us) | 1977-10-13 |
| INTRAVENOUS FILTER W/FLASH BULB (K771827) | Jelco Laboratories | 1977-10-13 |
| IV CATHETER HUB (K771381) | Jelco Laboratories | 1977-10-13 |
| EMIT THYROXINE CONTROL (K771657) | Syva Co. | 1977-10-13 |
| EXAM GLOVES (K771757) | Jamar Health Products | 1977-10-13 |
| COLOR COTE (K771863) | Williams Gold Refining Co., Inc. | 1977-10-13 |
| INTRAVENOUS FILTER W/AUTO AIR VENT (K771826) | Jelco Laboratories | 1977-10-13 |
| SUOGIPEEL PACKAGING SYSTEM (K771846) | Surgicot, Inc. | 1977-10-13 |
| ELASTOMULL GAUZE BANDAGE (K771758) | Beiersdorf, Inc. | 1977-10-13 |
| CATHETER DRESSING CHANCE SET (K771712) | Shield Laboratories, Inc. | 1977-10-13 |
| RADOVAN SUBCUTANEOUS TISSUE EXPANDER (K771224) | Heyer Schulte Corp. | 1977-10-11 |
| QUAN. COLOR. DETER. OF SERUM ALBUMIN (K771771) | Stanbio Laboratory | 1977-10-07 |
| HEMOGLOBIN A2 TESTING SYSTEM (K771649) | Isolab, Inc. | 1977-10-07 |
| DETECTOTERGE AZIDE FREE (K771790) | J.T. Baker Chemical Co. | 1977-10-07 |
| OMNICOR PROGRAMMER MODEL 222A (K771855) | Cordis Corp. | 1977-10-07 |
| SIGMOSCOPE (K771815) | Dynatech Cryomedical Co. | 1977-10-07 |
| BLANKING SOLUTION HGB (K771789) | J.T. Baker Chemical Co. | 1977-10-07 |
| STEPPER (K771539) | Tridak | 1977-10-07 |
| GOAT LAMBDA-LIGHT CHAIN ANTI-HUMAN SERUM (K771768) | G.D. Searle and Co. | 1977-10-07 |
| GAS CHROMATOGRAPH (K771256) | Varian Assoc., Inc. | 1977-10-07 |
| T3U (K771766) | Union Carbide Corp. | 1977-10-07 |
| CYMET-AUTOMATED (K771788) | J.T. Baker Chemical Co. | 1977-10-07 |
| MODEL 2/2 ANALYZER (K771245) | Eastman Kodak Company | 1977-10-07 |
| AZIDE FREE BLOOD DILUTING REAGENT (K771787) | J.T. Baker Chemical Co. | 1977-10-07 |
| CARBON DIOXIDE ANALYZER (K771610) | Corning Medical & Scientific | 1977-10-07 |
| IGOXIN SOLID PHASE RIA (K771638) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-10-07 |
| WORRELL PATELLA (K771708) | Depuy, Inc. | 1977-10-06 |
| WORRELL TRIAL PATELLA (K771709) | Depuy, Inc. | 1977-10-06 |
| CARBA LINGUARDUC (K771825) | C.R. Bard, Inc. | 1977-10-06 |
| WORRELL PATELLA TEMPLATE (K771710) | Depuy, Inc. | 1977-10-06 |
| SLIDE STAINERS GLS 360 & 360-1 (K771714) | Honeywell, Inc. | 1977-10-05 |
| CATHETERIZATION SYS. URINARY DRAINAGE (K771779) | Medical Devices, Inc. | 1977-10-05 |
| PATCH FABRIC (K770835) | Usci, Div. C.R. Bard, Inc. | 1977-10-05 |
| DINIMAP MODEL 827A (K771782) | Applied Medical Research | 1977-10-04 |
| ACA SALICYLATE CALIBRATOR (K771805) | E.I. Dupont DE Nemours & Co., Inc. | 1977-10-04 |
| MAGNATHERM 2000 (K771540) | Intl. Medical Electronics , Ltd. | 1977-10-04 |
| RS-7800 MINIPUMP (K771705) | Renal Systems, Inc. | 1977-10-04 |
| SOLID OXYGEN SYSTEM (K771761) | Jet Research Center, Inc. | 1977-10-04 |
| NEEDLE COUNTING (K771791) | Chase Mfg. Co. | 1977-10-04 |
| DINAMAP MODEL 825A (K771772) | Applied Medical Research | 1977-10-04 |
| NEEDLE HOLDER, MICROVASCULAR (K771859) | Edward Weck, Inc. | 1977-10-04 |
| HEMO-RO (K771763) | Millipore Corp. | 1977-10-04 |
| MODULAR HEARING DEVICE, MODEL S291 (K771762) | Vicon Instrument Co. | 1977-10-04 |
| ENTERIC 20 (K771703) | Inolex Corp./Div of Biomedical | 1977-10-04 |
| TUBING SETS (K771692) | Cobe Laboratories, Inc. | 1977-10-04 |
| LAS-R TM (K771780) | Hyland Therapeutic Div., Travenol Laboratories | 1977-10-04 |
| I.V. PREP & CARE KIT (K771551) | Jelco Laboratories | 1977-10-04 |
Track 1977 automatically
Every clearance here is in the API, with alerts when new ones post.