1978
1,975 FDA 510(k) clearances · Clearance year
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| Record | Firm | Date |
|---|---|---|
| OXYGEN THERAPY KIT (K780084) | Thermadyne Holings Corp. | 1978-01-30 |
| INFUSION APPARATUS, POWERED (K780086) | Ohio Medical Products | 1978-01-30 |
| LENS, HARD RESIN (K772221) | Borani Intl. | 1978-01-30 |
| LASER IMMUNONEPHELOMETRIC ANALYZER (K772361) | G.D. Searle and Co. | 1978-01-30 |
| CANE/REACHER (K780085) | Fred Sammons, Inc. | 1978-01-30 |
| PACEMAKER, PERM. & TEMP., ELECTRODE (K772197) | Daig Corp. | 1978-01-30 |
| MDL-201 (K772051) | Pacesetter Systems | 1978-01-30 |
| TRAPEZE FLOOR BASE (K772261) | Med Fusion Systems, Inc. | 1978-01-26 |
| BAG, DRAINAGEW/ADHESIVE; PROSTHESIS (K772366) | Atlantic Surgical | 1978-01-26 |
| HEEL OR ELBOW PROTECTOR (K772419) | Fred Sammons, Inc. | 1978-01-26 |
| TRAPEZE BAR KNOCKED DOWN (K772262) | Med Fusion Systems, Inc. | 1978-01-26 |
| RESPITRACE (K772016) | Respitrace Corp. | 1978-01-26 |
| GLOVE & LATEX FINGER COTS (K772336) | Jamar Health Products | 1978-01-26 |
| TELESCOPING BEDRAILS (K772260) | Med Fusion Systems, Inc. | 1978-01-26 |
| BLOOD LINE COMP. NEG. PRESS. PILLOW (K772355) | Cordis Corp. | 1978-01-26 |
| SYRINGE, BLOOD, SAMPLING, ARTERIAL (K772338) | C.R. Bard, Inc. | 1978-01-26 |
| TUBING CLAMP (K772405) | Fred Sammons, Inc. | 1978-01-26 |
| CILCO ANTERIOR CHAMBER LENS (K771933) | California Intraocular Lens | 1978-01-26 |
| QUADRIPLEGIC URINARY DRAINAGE VALVE (K772402) | Fred Sammons, Inc. | 1978-01-26 |
| SPIRAFLOW DIALYZERS (K772423) | Bentley Laboratories, Inc. | 1978-01-26 |
| FILTERSET W/Y-INJECTION SITE, 0.2 (K772312) | Abbott Laboratories | 1978-01-26 |
| TAMPON, HEAVY DUTY, & STICK (K780058) | Kimberly-Clark Corp. | 1978-01-26 |
| PRINTER (K772099) | Miles Laboratories, Inc. | 1978-01-26 |
| ACCELERATOR, LINEAR, MED. (K780027) | Emi Therapy Systems, Inc. | 1978-01-26 |
| GENERATOR, OXYGEN, PORTABLE (K780020) | Jet Research Center, Inc. | 1978-01-26 |
| SPECIMEN COLLECTION DEVICE (K780049) | Urol, Inc. | 1978-01-26 |
| THERMOMETER SHEATHS (K772365) | Medline Industries, Inc. | 1978-01-26 |
| CAMERA, GAMMA (K780060) | Ackerman-Schmehl Industries, Inc. | 1978-01-26 |
| DIALYZER STANDARD, CODE 5DM1780 (K772318) | Travenol Laboratories, S.A. | 1978-01-26 |
| FILTER, PERITONEAL DIALY. ADMIN. SET (K772236) | Millipore Corp. | 1978-01-24 |
| LDH ISOENZYME COLUMN REAGENT SET (K772356) | Worthington Biochemical Corp. | 1978-01-24 |
| NEEDLES USED IN ANGIOGRAPHIC PROCED. (K772369) | Argon Medical Corp. | 1978-01-24 |
| MINIMAP MODEL 810 (K771981) | Applied Medical Research | 1978-01-24 |
| TOWEL, DRAPE, BOUNDARY (K780036) | Procter & Gamble Mfg. Co. | 1978-01-24 |
| STETHOSCOPE, ELECTRONIC (K772173) | Affiliated Mailorder Co. Sales, Inc. | 1978-01-24 |
| PULSE GENERATORS, MODELS 5972/5973 (K780061) | Medtronic Vascular | 1978-01-24 |
| EPILATOR, ELECTRONIC MODEL SE-2 (K780076) | R. A. Fischer Co. Corp. | 1978-01-24 |
| LAS-R HUMAN PLASMINOGEN TEST (K772085) | Hyland Therapeutic Div., Travenol Laboratories | 1978-01-24 |
| LAS-R HUMAN C3 PROACTIVATOR TEST (K772084) | Hyland Therapeutic Div., Travenol Laboratories | 1978-01-24 |
| PERITONEAL DIALYSIS ADMIN. SET (K780082) | Physio-Control Corp. | 1978-01-24 |
| ELECTRODE CAP (K780045) | Electro-Cap Intl., Inc. | 1978-01-24 |
| CULTURE MEDIA/ISOLA. PATHO. NEISSERIA (K780022) | Diagnostic Culture System | 1978-01-20 |
| ENDOSOLV E (K780003) | Septodont, Inc. | 1978-01-20 |
| DENTAL HANDPIECE (K780038) | Lares Manufacturing Co., Inc. | 1978-01-20 |
| GOAT ANTI-RUBELLA ANTISERA (K780010) | Northeast Biomedical Labs., Inc. | 1978-01-20 |
| INSTRUMENT TRAY (K772266) | Med Fusion Systems, Inc. | 1978-01-20 |
| FLUORESCENCE DETECTOR MODEL 420 (K780031) | Waters Assoc., Inc. | 1978-01-20 |
| GOAT ANTI-INFLUENZA ANTISERA (K780004) | Northeast Biomedical Labs., Inc. | 1978-01-20 |
| INSULIN RIA MODULE (K771947) | Inter Science Institute | 1978-01-20 |
| ANTITHROMBIN III RIA (K780012) | Ria Diagnostics | 1978-01-20 |
| AMINOGLYCOSIDE TEST SYSTEM (K780048) | Nichols Institute Diagnostics | 1978-01-20 |
| GOAT ANTI-INFLUENZA ANTISERA (K780006) | Northeast Biomedical Labs., Inc. | 1978-01-20 |
| PROSTHESIS, DOUBLE CUP (K780052) | Depuy, Inc. | 1978-01-20 |
| HEARING AID, BEHIND-THE-EAR (K780067) | Maico Hearing Instruments, Inc. | 1978-01-20 |
| RUBENOSTICON (K780063) | Organon, Inc. | 1978-01-20 |
| FIAX TEST FOR ANTI-RUBELLA ANTIBODY (K772219) | Idt, A Division of Whittaker M.A. Bioproducts | 1978-01-20 |
| CONVERSE-GILLIES NEEDLE HOLDER (K772388) | Edward Weck, Inc. | 1978-01-20 |
| ILLUMINATED DENTAL HANDPIECE (K772244) | Litton Dental Products | 1978-01-20 |
| GOAT ANTI-INFLUENZA ANTISERA (K780005) | Northeast Biomedical Labs., Inc. | 1978-01-20 |
| GOAT ANTI-INFLUENZA ANTISERA (K780007) | Northeast Biomedical Labs., Inc. | 1978-01-20 |
| GUINEA PIG WHOLE SERUM (K780009) | Northeast Biomedical Labs., Inc. | 1978-01-20 |
| GLUCAGON RIA MODULE (K771948) | Inter Science Institute | 1978-01-20 |
| GASTRIN RIA MODULE (K771953) | Inter Science Institute | 1978-01-20 |
| GOAT ANTI-INFLUENZA ANTISERA (K780008) | Northeast Biomedical Labs., Inc. | 1978-01-20 |
| DENTAL LIGHT (K772351) | Chemetron Dental Products | 1978-01-17 |
| THIN-BLADED NASAL SPECULUM (K772385) | Edward Weck, Inc. | 1978-01-17 |
| INSPIRON MANIFOLD (DOUBLE) (K772294) | C.R. Bard, Inc. | 1978-01-17 |
| BARRAQUER OVAL SPECULUM-VARIOUS SIZES (K772370) | Edward Weck, Inc. | 1978-01-17 |
| PULSE GENERATORS (K772357) | Medtronic Vascular | 1978-01-17 |
| FARRIOR OVAL SPECULUM (K772380) | Edward Weck, Inc. | 1978-01-17 |
| BOIES NASAL FRACTURE ELEVATOR (K772391) | Edward Weck, Inc. | 1978-01-17 |
| HILDYARD POST NASAL FORCEP (K772377) | Edward Weck, Inc. | 1978-01-17 |
| MYRINGOTOMY KNIFE (K772384) | Edward Weck, Inc. | 1978-01-17 |
| BRACE, TENNIS ELBOW (K780053) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-01-17 |
| INSPIRON MANIFOLD (SINGLE) (K772295) | C.R. Bard, Inc. | 1978-01-17 |
| EPIDURAL LEAD - MODEL 3481 (K780001) | Medtronic Vascular | 1978-01-17 |
| COTTLE COLUMELLA FORCEP (K772397) | Edward Weck, Inc. | 1978-01-17 |
| ROLLER KNIFE (K772372) | Edward Weck, Inc. | 1978-01-17 |
| INSPIRON MANIFOLD (K772296) | C.R. Bard, Inc. | 1978-01-17 |
| ALLIGATOR CUP FORCEPS (K772396) | Edward Weck, Inc. | 1978-01-17 |
| RING HANDLE & RETRACTORS (K772381) | Edward Weck, Inc. | 1978-01-17 |
| DINGMAN ZYGOMA ELEVATOR (K772399) | Edward Weck, Inc. | 1978-01-17 |
| ALLPORT MASTOID RETRACTORS (K772392) | Edward Weck, Inc. | 1978-01-17 |
| URINARY LEG BAG (K780032) | C.R. Bard, Inc. | 1978-01-17 |
| DAY EAR HOOK (K772390) | Edward Weck, Inc. | 1978-01-17 |
| COTTLE LOWER LATERAL FORCEPS (K772398) | Edward Weck, Inc. | 1978-01-17 |
| ORTHODONTIC. PLASTIC BRACKET PRIMER (K780028) | 3M Company | 1978-01-17 |
| MUSCLE STIMULATOR (K772287) | Rich-Mar Corp. | 1978-01-13 |
| EMI THERAPY SIMULATOR (K771817) | Emi Therapy Systems, Inc. | 1978-01-13 |
| T4 RIA KIT (K772330) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-01-12 |
| LITTON 300L ULTRASOUND SYSTEM (K770999) | Electra-Physics Laboratories, Inc. | 1978-01-12 |
| ARRHYTHMIA MODULE (K772360) | General Electric Co. | 1978-01-12 |
| WISP MODEL 710 (K772311) | Waters Assoc., Inc. | 1978-01-12 |
| DENSITOMETER 18, COMPUTING, AUTO. (K772325) | Gelman Instrument Co. | 1978-01-12 |
| ANALYZER, CLINICAL, SYSTEM 3 (K772319) | Gilford Instrument Laboratories, Inc. | 1978-01-12 |
| TESTOSTERONE RIA KIT (125I) (K772191) | Diagnostic Products Corp. | 1978-01-12 |
| KANAMYCIN RIA (K772038) | Monitor Science Corp. | 1978-01-12 |
| INTERMEDULLARY BRUSH (K771016) | Howmedica Corp. | 1978-01-12 |
| NEONATAL TSH RIA KIT (125I) (K772192) | Diagnostic Products Corp. | 1978-01-12 |
| URINARY 17-KETOSTERIOD/17 (K772337) | Eppendorf-Brinkmann, Inc. | 1978-01-12 |
Track 1978 automatically
Every clearance here is in the API, with alerts when new ones post.