1
32,815 FDA 510(k) clearances · Device class
Download CSV table Client report (share link) ◉ Watch
Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.
| Record | Firm | Date |
|---|---|---|
| ENEMA SET (K771792) | Chase Mfg. Co. | 1977-10-20 |
| CAPMIX (K771901) | Espe Dental Products | 1977-10-20 |
| MEDPRO FLOTATION SYSTEM (K771824) | Medpro, Inc. | 1977-10-19 |
| GLYCOPROTEIN TEST, LAS-R HUMAN 1-ACID (K771879) | Hyland Therapeutic Div., Travenol Laboratories | 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 |
| ENZYMATIC CHOLESTEROL (K771820) | Macomb Chemical Co. | 1977-10-19 |
| FOLLICLE-STIMULATING HORMONE (K771756) | Nichols Institute Diagnostics | 1977-10-18 |
| I.L. MODEL 643 FLAME PHOTOMETER (K771337) | Instrumentation Laboratory CO | 1977-10-18 |
| CHOLESTEROL (K771833) | Gamma Enterprises, Inc. | 1977-10-18 |
| TEK-CHEK-2 (K771713) | Miles Laboratories, 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 |
| EMIT THYROXINE CONTROL (K771657) | Syva Co. | 1977-10-13 |
| EXAM GLOVES (K771757) | Jamar Health Products | 1977-10-13 |
| ELASTOMULL GAUZE BANDAGE (K771758) | Beiersdorf, Inc. | 1977-10-13 |
| CATHETER DRESSING CHANCE SET (K771712) | Shield Laboratories, Inc. | 1977-10-13 |
| STEPPER (K771539) | Tridak | 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 |
| WORRELL TRIAL PATELLA (K771709) | Depuy, 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 |
| NEEDLE HOLDER, MICROVASCULAR (K771859) | Edward Weck, Inc. | 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 |
| I.V. PREP & CARE KIT (K771551) | Jelco Laboratories | 1977-10-04 |
| THOREK SCISSORS 7 1/4 & 10 (K771806) | J. Sklar Mfg. Co., Inc. | 1977-10-04 |
| SUTURE CLIP REMOVER (K771640) | United States Surgical, A Division of Tyco Healthc | 1977-09-30 |
| NEW BASE FOR ORTHODONTIC APPLIANCES (K771774) | Gac Intl., Inc. | 1977-09-30 |
| PATIENT RESTRAINT SYSTEM (K771659) | Mtd, Inc. | 1977-09-30 |
| CATHETEO CARE TRAY #0242 (K771673) | Concord Laboratories, Inc. | 1977-09-30 |
| LIMB RESTRAINT (K771630) | Medical Restraints, Inc. | 1977-09-30 |
| COLORPLAST TRANSVERSE SYSTEM (K771775) | C.R. Bard, Inc. | 1977-09-30 |
| HAND RESTRAINT (K771629) | Medical Restraints, Inc. | 1977-09-30 |
| SUTURE TISSUE APPROXIMATING FORCEP (K771515) | United States Surgical, A Division of Tyco Healthc | 1977-09-30 |
| BODY RESTRAINT (K771636) | Medical Restraints, Inc. | 1977-09-30 |
| MALE URINAL (K771738) | Bemis Health Care | 1977-09-28 |
| FINGER MITT RESTRAINT (K771632) | Medical Restraints, Inc. | 1977-09-28 |
| RASPS FOR SCRAPING BONE (K771745) | Depuy, Inc. | 1977-09-28 |
| PERIOSTEAL ELEVATOR (K771747) | Depuy, Inc. | 1977-09-28 |
| 8 EMESIS BASIN (K771733) | Bemis Health Care | 1977-09-28 |
| FOOT ELEVATOR (K771635) | Medical Restraints, Inc. | 1977-09-28 |
| EXTEMP-V (K771759) | Pharmaco, Inc. | 1977-09-28 |
| AMALGAM DISPENSER (K771749) | New Dimensions IN Medicine, Inc. | 1977-09-28 |
| INTRA ORAL X-RAY CONES (K771748) | General Electric Co. | 1977-09-28 |
| THORNTON ANTERIOR CHAMBER IRRIGATOR (K771732) | Concept, Inc. | 1977-09-28 |
| MICROFLATOR (K771679) | Fisons Corp. | 1977-09-28 |
| OSTEOTOMES FOR CUTTING BONH (K771744) | Depuy, Inc. | 1977-09-28 |
| EXTEMP (K771760) | Pharmaco, Inc. | 1977-09-28 |
| VEST RESTRAINT (K771634) | Medical Restraints, Inc. | 1977-09-28 |
| PELVIC WHEELCHAIR RESTRAINT (K771715) | Medical Restraints, Inc. | 1977-09-28 |
| SURG. SCISSORS FOR CUTTING TISSUE (K771743) | Depuy, Inc. | 1977-09-26 |
| FORCEPS (K771746) | Depuy, Inc. | 1977-09-26 |
| BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE. (K771725) | Xomed, Inc. | 1977-09-26 |
| ESOPHAGEAL STETH. TEMP. SENSOR (K771411) | Labarge, Inc. | 1977-09-23 |
| ANGLED FORCEP APPLIER (K771691) | Edward Weck, Inc. | 1977-09-22 |
| SPECTROPHOTOMETEO IL MODEL 651 (K771604) | Instrumentation Laboratory CO | 1977-09-22 |
| NSULIN RIA KIT 125I (K771628) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-09-20 |
| MINISTAT-S CHEMISTRY ANALYZER (K771591) | Biokinetix Corp. | 1977-09-20 |
| FOOT DROP BOOT (K771676) | Medical Restraints, Inc. | 1977-09-20 |
| GAMMA CAMERAS -GXA-301 & GCA-402 (K771599) | Toshiba Medical Systems | 1977-09-20 |
| CARDIO-EXERCISE TREADMILL 550 (K771697) | Quinton, Inc. | 1977-09-20 |
| CURITY IRRIGATION TRAY (K771079) | Kendall Research Center | 1977-09-15 |
| A-GENT TRIGLYCERIDES (K771608) | Abbott Laboratories | 1977-09-15 |
| SPIR-E-VAC (K771241) | Breathing Services, Inc. | 1977-09-15 |
| CHOLOPAP-HDL (K771586) | Advanced Biomedical Methods, Inc. | 1977-09-15 |
| AMPLIFIER MODEL N5A-HIS (K771685) | Honeywell, Inc. | 1977-09-14 |
| ORTHO H FILM (K771681) | Eastman Kodak Company | 1977-09-14 |
| AMPLIFIER MODEL N5A-ECG (K771684) | Honeywell, Inc. | 1977-09-14 |
| LIQ. SCINTILLATION SPECTROPHOTOMETEO (K771369) | Beckman Instruments, Inc. | 1977-09-14 |
| MULTISTAT III X-HBDH TEST (K771474) | Instrumentation Laboratory CO | 1977-09-13 |
| CARA-STAIN MODEL 3000 (K771699) | American Safety Equipment Corp. | 1977-09-13 |
| HOLESTEROL DELTA TEST ASSAY (K771582) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-09-13 |
| MULTISTAT III URIC ACID TEST (K771509) | Instrumentation Laboratory CO | 1977-09-13 |
| MULTISTAT III CHOLESTEROL TEST (K771508) | Instrumentation Laboratory CO | 1977-09-13 |
| CONFORM STRETCH BANDAGE (5SIZES) (K771452) | Kendall Research Center | 1977-09-12 |
| MULTISTAT III PHOSPHOROUS TEST (K771477) | Instrumentation Laboratory CO | 1977-09-12 |
| WHEELCHAIR SAFETY BELT (K771631) | Medical Restraints, Inc. | 1977-09-12 |
| AMHS BLOOD ANALY. TRIGLYCEOIDES REAG. KI (K771004) | Miles Laboratories, Inc. | 1977-09-12 |
| LEININGEO AORTIC PUNCH #310-395 & 397 (K771625) | J. Jamner Surgical Instruments, Inc. | 1977-09-12 |
| ENDOSCOPIC TRAY (K771049) | American Hospital Supply Corp. | 1977-09-12 |
| MULTISTAT III MAGNESIUM TEST (K771469) | Instrumentation Laboratory CO | 1977-09-12 |
| HEEL PROTECTOR (K771633) | Medical Restraints, Inc. | 1977-09-12 |
| IRRIGATION/ASPIRATION NEEDLE (K771416) | Concept, Inc. | 1977-09-12 |
| MIDDLEBROOK 7H11 AGAR (PLATE) (K771661) | Granite Diagnostics, Inc. | 1977-09-12 |
| CONFORM ELASTIC NETTING (K771563) | Kendall Research Center | 1977-09-12 |
| IDENTOFLEX (K771658) | Cavitron Corp. | 1977-09-12 |
| STERILE SUTURE REMOVAL KIT (K771448) | Premium Plastics, Inc. | 1977-09-06 |
| COPE LUNG FORCEPS #305-218 (K771624) | J. Jamner Surgical Instruments, Inc. | 1977-09-06 |
| ELECTRONIC EIPLATOR MODEL NO. 101 (K771575) | Electronic Depilatory, Inc. | 1977-09-06 |
| SUTURE RETENTION CLAMP (K771554) | Concept, Inc. | 1977-09-02 |
| MULTISTAT III TRIGLYCERIDE TEST (K771472) | Instrumentation Laboratory CO | 1977-09-02 |
| SPECI-MIX (K771617) | Thermolyne Corp. | 1977-09-02 |
| MULTISTAT III ALANINE AMINOTRANSFERASE (K771466) | Instrumentation Laboratory CO | 1977-09-02 |
| SERONORM (K771436) | Nyegaard & Co. A/S | 1977-09-02 |
| AUTONORM (K771438) | Nyegaard & Co. A/S | 1977-09-02 |
| TEKTALLY II (K771580) | Scientific Products | 1977-09-02 |
| API 20A (K771616) | Analytical Products, Inc. | 1977-09-02 |
Track 1 automatically
Every clearance here is in the API, with alerts when new ones post.