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 |
|---|---|---|
| UNIPOPLAR ENDOCARDIAL LEADS (K781326) | American Technology, Inc. | 1978-12-04 |
| URINARY DRAINAGE BAG (K781987) | Kelsar Corp. | 1978-12-04 |
| ENDOCARDIAL BIPOLAR LEAD (K781456) | American Technology, Inc. | 1978-12-04 |
| PFT GASES (K781523) | Gardner Cryogenics | 1978-12-01 |
| RESPONSE SYSTEM, TN-3000 (K781743) | Tracor Instruments, Inc. | 1978-12-01 |
| MASK, BI FLO NASAL OXYGEN (K781741) | Inhal-O-Tech Medical Plastic | 1978-12-01 |
| STIMULATOR, TN-3001 SOMATOSENSORY (K781704) | Tracor Instruments, Inc. | 1978-12-01 |
| MEDICAL PROTEIN HYDROLYSATE REVITAL (K780775) | Robertson Resources, Inc. | 1978-11-30 |
| ECG ANALYZER, HIGH SPEED (K781911) | Cardio-Dynamics Laboratories, Inc. | 1978-11-30 |
| BLOOD PRESSURE RECORDER (K781932) | Cardiodyne, Inc. | 1978-11-29 |
| CALIBRATOR, DYNAMIC (K781692) | Waters Assoc., Inc. | 1978-11-29 |
| SLICK SET, CUFFED (K781808) | Polamedco, Inc. | 1978-11-29 |
| EKG ELECTRODES, DISPOSABLE (K781940) | Hayes Products, Inc. | 1978-11-29 |
| CATHETER INTRODUCERS, ARTERISE (K781954) | C.R. Bard, Inc. | 1978-11-29 |
| PNEUMOGARD MODEL 1230 (K781714) | Novametrix Medical Systems, Inc. | 1978-11-27 |
| CLINAC 2500 (K781872) | Varian Assoc., Inc. | 1978-11-27 |
| L/U ARM-VASCULAR (K781571) | General Electric Co. | 1978-11-27 |
| RESCAL (K781759) | Diemolding Corp. | 1978-11-27 |
| BREATHING CIRCUIT PRODUCTS, ANESTHESIA (K781908) | Hospitak, Inc. | 1978-11-27 |
| CAMERA, GCA-10A, LOW ENERGY (K781739) | Toshiba Medical Systems | 1978-11-27 |
| IMV SYSTEM (K780340) | Lkb Instruments, Inc. | 1978-11-27 |
| DROPPER, CEPTI-SEAL LAVTOPHENOL (K781868) | Marion Laboratories, Inc. | 1978-11-22 |
| DELTA-FLOW (K780479) | Tri-Delta Intl. | 1978-11-22 |
| REAGENT, FIREFLY #395 (K781807) | Chrono-Log Corp. | 1978-11-22 |
| REAGENT, HDL (K781740) | Fisher Scientific Co., LLC | 1978-11-22 |
| LDH REAGENT SYSTEM (K781765) | American Monitor Corp. | 1978-11-22 |
| PLATE, LD PRESUMPTO (K781856) | Anaerobe Systems | 1978-11-22 |
| PROCAINAMIDE CALIBRATOR KIT (K780732) | Vitek Systems, Inc. | 1978-11-22 |
| COLLINS PEDALMATE 2 (K781889) | Warren E. Collins, Inc. | 1978-11-22 |
| EXTRACTOR, SABIAN FOREIGN BODY (K781737) | Sabian Corp. | 1978-11-22 |
| CUTTER RESIFLEX URINE METER (K781521) | Cutter Laboratories, Inc. | 1978-11-22 |
| RUBELISA TEST KIT (K780996) | Microbiological Assoc. | 1978-11-22 |
| TOTAL PROTEIN (K781774) | Gilford Diagnostics | 1978-11-22 |
| VOLUMETRIC CONTROLLER MODEL 310 (K781589) | Imed Corp. | 1978-11-22 |
| NEUROPAC ULTRA II (K781829) | Medical Devices, Inc. | 1978-11-22 |
| DROPPER, CEPTI-SEAL KOH SOLUTION (K781869) | Marion Laboratories, Inc. | 1978-11-22 |
| ALBUMIN REAGENT (K781773) | Gilford Diagnostics | 1978-11-22 |
| POUCHES, GAS STERILIZATION (K781925) | Medicare Industries, Inc. | 1978-11-22 |
| RIA, CORTISOL KIT (K781730) | Radioassay Systems Laboratories, Inc. | 1978-11-22 |
| LDH (K781775) | Gilford Diagnostics | 1978-11-22 |
| 125I-ALDOSTERONE RIA DIAG. KIT (K781504) | Abbott Laboratories | 1978-11-22 |
| EAR STOPPLES FOR NOISE ATTENTION (K781907) | Crown Delta Corp. | 1978-11-22 |
| POUCHES AND TUBING, MEDI-SEAL (K781924) | Medicare Industries, Inc. | 1978-11-22 |
| MEDICAL GRADE SILICONE ELASTOMER TUBING (K781087) | Mcghan Medical Corp. | 1978-11-22 |
| CALCULATOR, WITH CHARGER (K781838) | C.R. Bard, Inc. | 1978-11-21 |
| CAMSCAN SYSTEM (K781845) | American Optical Corp. | 1978-11-20 |
| BLOOD PRESSURE DEVICE, 400 SERIES (K781906) | Med-Tek Corp. | 1978-11-16 |
| BLOOD PRESSURE CUFF COVER (K781671) | David Cott Co. | 1978-11-16 |
| FILTER, EXTRACORPOREAL BLOOD HOLDER (K781861) | Surgikos, Inc. | 1978-11-15 |
| CALIBRATOR, BOVINE SERUM (K781702) | Bio-Reagents & Diagnostics, Inc. | 1978-11-15 |
| HEMACHECK (K781562) | Vickers America Medical Corp. | 1978-11-15 |
| MACRO-VUE TEST, GENTAMICIN (K781674) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-11-15 |
| HEARING AID, MODEL 781 (K781881) | Danavox, Inc. | 1978-11-15 |
| RETINOMETER (K781507) | Coburn Optical Ind., Inc. | 1978-11-15 |
| CANNULA CADDY (K781866) | Katena Products, Inc. | 1978-11-15 |
| REFLECT IMPRESSION MATERIAL (K781689) | Kerr Corporation (Danbury) | 1978-11-15 |
| PIPETTES, PLASTIC DISPOSABLE (K781891) | Hillwood Corp. | 1978-11-15 |
| QUANTICEL HHR # L500 AND L501 (K781786) | Bhp Diagnostix, Inc. | 1978-11-15 |
| GLOVE, SUPERFLEX MOLDED (K781852) | Pinnacle Distributors, Inc. | 1978-11-15 |
| LAPARATOMY SPONGE (K781818) | Meden Medical Sales Division | 1978-11-15 |
| QUANTICEL HHR, L531 AND L532 (K781745) | Bhp Diagnostix, Inc. | 1978-11-15 |
| MULAR GOLD LEAF ELECTRODE MODEL 7501 (K781476) | Life-Tech Instruments, Inc. | 1978-11-15 |
| SKIN MARKING PEN (K781770) | Abco Dealers, Inc. | 1978-11-15 |
| SILASTIC H.P. TRAPEXIAL IMPLANT (K781756) | Dow Corning Corp. Healthcare Industries Materials | 1978-11-15 |
| PLASMINOGEN ASSAY (K781478) | Dade, Baxter Travenol Diagnostics, Inc. | 1978-11-15 |
| AIR POWERED DENTAL HANDPIECE (K781545) | Promident Mfg., Ltd. | 1978-11-15 |
| WOUND SPAN BRIDGE III (K781837) | Howmedica Corp. | 1978-11-15 |
| BIOPSY KIT 781101, ASPIRATION (K781830) | Vista Products, Inc. | 1978-11-15 |
| CATHETERS, H-H ATRIAL AND PERITONEAL (K781768) | Holter-Hausner Intl. | 1978-11-14 |
| EXERCISER, AIR-EZE INCENTIVE (K781833) | Chesebrough-Pond'S U.S.A. Co. | 1978-11-14 |
| TEMPERATURE CONTROLLER MODEL 17000 (K781530) | Healthdyne, Inc. | 1978-11-14 |
| SANI-DENT DENTURE CLEANER (K781779) | Sandi-Dent | 1978-11-08 |
| PNEUMATIC VITRECTOMY CONTROL UNIT (K781471) | Helfgott Medical Instruments | 1978-11-08 |
| EXTERNAL ARTICULATION (K781840) | Ace Orthopedic Manufacturing Co. | 1978-11-08 |
| NEPHELRATE ANTISERUMS C3C (K781653) | Antibodies, Inc. | 1978-11-08 |
| SULFATE, FIBRIQUIK PROTAMINE (K781814) | General Diagnostics | 1978-11-08 |
| OXYGENATOR, BLOOD BOS-10 (K781842) | Bentley Laboratories, Inc. | 1978-11-08 |
| ACU-DOT (K781672) | Acu-Dot Pharmaceutical Intl., Inc. | 1978-11-08 |
| THE VISUAL SPEECH AID (K781522) | Exeter Medical Labs, Inc. | 1978-11-08 |
| ANTITHROMBIN III ASSAY (K781480) | Dade, Baxter Travenol Diagnostics, Inc. | 1978-11-08 |
| NEPHELRATE ANTISERUMS 1GA (K781655) | Antibodies, Inc. | 1978-11-08 |
| BONE CLAMP, ACE EXTERNAL (K781839) | Ace Orthopedic Manufacturing Co. | 1978-11-08 |
| PREP TRAY, PREOPERATIVE SKIN (K781797) | Pharmaseal Div., Baxter Healthcare Corp. | 1978-11-08 |
| ACCUSCREEN T4 (K781222) | Neometrics, Inc. | 1978-11-08 |
| NEPHELRATE ANTIPERUMS LGM (K781654) | Antibodies, Inc. | 1978-11-08 |
| NEPHELRATE ANTISERUMS, IGG (K781656) | Antibodies, Inc. | 1978-11-08 |
| RIA, T3 UPTAKE SOLID PHASE (K781662) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-11-08 |
| BAR, DISTRACTION (K781841) | Ace Orthopedic Manufacturing Co. | 1978-11-08 |
| MODEL 7320 VISUAL STIMULATOR (K781461) | Life-Tech Instruments, Inc. | 1978-11-08 |
| SPLINT, HOAKE INFLATABLE AIR (K781754) | Depuy, Inc. | 1978-11-08 |
| BOARD, DISPOSABLE CONTROL COUNT (K781791) | Dexide, Inc. | 1978-11-08 |
| TRANSFER PAK 4R 9006 (K781811) | Travenol Laboratories, S.A. | 1978-11-08 |
| STIMULATOR, E.S.I. NEURO (K781670) | Evolutionary Systems, Inc. | 1978-11-07 |
| ANGIOGRAPHIC GUIDE WIRE (K781561) | Wilson Medical Instruments Co. | 1978-11-07 |
| GLYCOHEMOGLOBIN-SKREEN TEST KIT (K780819) | Eppendorf-Brinkmann, Inc. | 1978-11-07 |
| TECHNIQUE, CHROMATOGRAPHIC, HEMOGLOBIN (K780573) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-11-07 |
| HEMOGLOBIN, TESTING SYSTEM (K781851) | Isolab, Inc. | 1978-11-07 |
| DEVICE, FEMALE INCONTINENCE (K781863) | Eschmann Bros. & Walsh , Ltd. | 1978-11-06 |
| SCANNER, CT 0450 (K781752) | Pfizer Medical Systems, Inc. | 1978-11-03 |
| EXAMINER 10 (K781698) | American Sterilizer Co. | 1978-11-03 |
Track 1978 automatically
Every clearance here is in the API, with alerts when new ones post.