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32,815 FDA 510(k) clearances · Device class
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| Record | Firm | Date |
|---|---|---|
| SURGICAL ASPIRATOR TIPS (K781592) | Henry Schein, Inc. | 1978-12-04 |
| IRON 59 KIT (K781769) | Ria Products, Inc. | 1978-12-04 |
| PFT GASES (K781523) | Gardner Cryogenics | 1978-12-01 |
| MASK, BI FLO NASAL OXYGEN (K781741) | Inhal-O-Tech Medical Plastic | 1978-12-01 |
| MEDICAL PROTEIN HYDROLYSATE REVITAL (K780775) | Robertson Resources, Inc. | 1978-11-30 |
| 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 |
| DROPPER, CEPTI-SEAL LAVTOPHENOL (K781868) | Marion Laboratories, Inc. | 1978-11-22 |
| REAGENT, HDL (K781740) | Fisher Scientific Co., LLC | 1978-11-22 |
| PLATE, LD PRESUMPTO (K781856) | Anaerobe Systems | 1978-11-22 |
| DROPPER, CEPTI-SEAL KOH SOLUTION (K781869) | Marion Laboratories, Inc. | 1978-11-22 |
| FILTER, EXTRACORPOREAL BLOOD HOLDER (K781861) | Surgikos, Inc. | 1978-11-15 |
| HEARING AID, MODEL 781 (K781881) | Danavox, Inc. | 1978-11-15 |
| PIPETTES, PLASTIC DISPOSABLE (K781891) | Hillwood Corp. | 1978-11-15 |
| GLOVE, SUPERFLEX MOLDED (K781852) | Pinnacle Distributors, Inc. | 1978-11-15 |
| LAPARATOMY SPONGE (K781818) | Meden Medical Sales Division | 1978-11-15 |
| SKIN MARKING PEN (K781770) | Abco Dealers, Inc. | 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 |
| SANI-DENT DENTURE CLEANER (K781779) | Sandi-Dent | 1978-11-08 |
| PREP TRAY, PREOPERATIVE SKIN (K781797) | Pharmaseal Div., Baxter Healthcare Corp. | 1978-11-08 |
| SPLINT, HOAKE INFLATABLE AIR (K781754) | Depuy, Inc. | 1978-11-08 |
| HBDH ENZYME KINETIC REAGENT SET (K781720) | Medical Analysis Systems, Inc. | 1978-11-03 |
| REAGENT SET, SGPT SERUM GLUTAMIC (K781726) | Medical Analysis Systems, Inc. | 1978-11-03 |
| DISC, COLOPLAST PRE-OP STOMA (K781736) | C.R. Bard, Inc. | 1978-11-03 |
| REAGENT SET, CHOLESTEROL (K781721) | Medical Analysis Systems, Inc. | 1978-11-03 |
| LATEX, IN-HOUSE COMPOUNDED (K781847) | Arbrook Mfg. Corp. | 1978-11-03 |
| MAXI-CHAIR (K781801) | Surgical Mechanical Research, Inc. | 1978-11-03 |
| ISO-CARE KIT (K781539) | Nice-Pak Products, Inc. | 1978-11-03 |
| LUBE-LOK (K781695) | Olympic Medical Corp. | 1978-11-01 |
| SRD-2 (K781646) | Dynatech Laboratories, Inc. | 1978-10-27 |
| RIA KIT, LH (K781685) | Amersham Corp. | 1978-10-27 |
| AUTODILUTER 2 (K781645) | Dynatech Laboratories, Inc. | 1978-10-27 |
| KENDRICK EXTRICATION DEVICE (K781761) | Medi-Ked, Inc. | 1978-10-27 |
| MONOJECT SCALE MAGNIFIER (K781459) | Sherwood Medical Industries | 1978-10-24 |
| BAYLOW VISUAL ACUITY TESTER (K781452) | Codman & Shurtleff, Inc. | 1978-10-24 |
| BLADE, 20 ANGLE/MICRO BLADE HOLDER (K781716) | Edward Weck, Inc. | 1978-10-24 |
| CHOLESTEROL DET. IN SERUM (K781611) | Fisher Scientific Co., LLC | 1978-10-24 |
| STREP-TEX (K781607) | Burroughs Wellcome Co. | 1978-10-17 |
| PINT BOTTLE WELL (K781364) | Baxa Corp., Sub. of Cook Group, Inc. | 1978-10-17 |
| 24-HOUR URINE COLLECTION COOLING WRAP (K781557) | Sage Products, Inc. | 1978-10-17 |
| OBJECTS PRECISION HANDLING TEST KIT (K781350) | Metro. Hospital & Health Center | 1978-10-17 |
| MIC-BIO-PLATE (K781506) | Pasco Laboratories, Inc. | 1978-10-17 |
| PROJECTOR, ACCU-CHART ACUITY (K781658) | Bausch & Lomb, Inc. | 1978-10-17 |
| RIA CONTROLS (K781593) | Dade, Baxter Travenol Diagnostics, Inc. | 1978-10-17 |
| PILLOWS- SINGLE PATIENT USE (K781354) | Abco Dealers, Inc. | 1978-10-17 |
| TECHNICON AUTOSLIDE STAINING/PROCESSING (K781598) | Technicon Instruments Corp. | 1978-10-17 |
| TOWELS, SHEETS, PILLOWCASES (K781227) | Abco Dealers, Inc. | 1978-10-17 |
| BACK TRAC (K781647) | Tech Engineering, Inc. | 1978-10-17 |
| IDENTI-LOOPS (K780720) | Berkeley Bio-Medical, Inc. | 1978-10-17 |
| TERRY KERATOMETER (K781650) | Clifford M. Terry, M.C. | 1978-10-17 |
| MAXIRAY 125 TUBE UNIT (K781524) | General Electric Co. | 1978-10-17 |
| IDENTI-CLAMPS (K780721) | Berkeley Bio-Medical, Inc. | 1978-10-17 |
| MAXI-CAMERA 535 (K781673) | General Electric Co. | 1978-10-17 |
| I-ESTRIOL TEST SET (K781599) | Wien Laboratories, Inc. | 1978-10-17 |
| DISPOSABLE INCENTIVE SPIROMETER (K781394) | Inhal-O-Tech Medical Plastic | 1978-10-16 |
| NEBULIZER/HUMIDIFIER MODEL EH 147B (K781591) | Mistogen Equipment Co. | 1978-10-16 |
| RAD-291 (K781554) | Organon, Inc. | 1978-10-11 |
| NASOSTAT (K781615) | Nasostat, Inc. | 1978-10-11 |
| OSCILLATING KNIFE AND ACCESSORIES (K781412) | Codman & Shurtleff, Inc. | 1978-10-11 |
| ECHO-OIL (K781631) | Echo Laboratories, Inc. | 1978-10-10 |
| CDC ANAEROBE BLOOD AGAR (K781604) | Anaerobe Systems | 1978-10-10 |
| CDC ANAEROBE BLOOD AGAR W/PHENETHYLALCH. (K781603) | Anaerobe Systems | 1978-10-10 |
| HEMATOXYLIN STAIN HARRIS (K781585) | Bioscientific | 1978-10-10 |
| R&R ABSORBENT POINTS (K781605) | Ransom and Randolph | 1978-10-10 |
| SURGITEK DISPOSABLE FLO-RESTER (K781336) | Medical Engineering Corp. | 1978-10-10 |
| PAPANICOLAOU STAIN EA-36 (K781582) | Bioscientific | 1978-10-10 |
| EPILATOR, EASE-MULTI-MODE (K781147) | Greenleaf-Carter Enterprises, Inc. | 1978-10-10 |
| GRAM STAIN KIT (K781584) | Bioscientific | 1978-10-10 |
| PAPANICOLAOU STIAN OG-6 (K781588) | Bioscientific | 1978-10-10 |
| HEMATOLOGY STAIN PACK (K781587) | Bioscientific | 1978-10-10 |
| FUNGUS FIGHTER INSOLES (K780719) | Combe, Inc. | 1978-10-10 |
| RUBBER DAM HOLDER (K781520) | Young Dental Manufacturing Co. 1, LLC | 1978-10-10 |
| PAPANICOLAOU STAIN :EA-50: (K781583) | Bioscientific | 1978-10-10 |
| HEARING AID, ITE MODULAR MODEL I, II, V (K781663) | Oticon Corp. | 1978-10-10 |
| CDC ANAEROBE BLOOD W/KANAMYAN/VANCOM. (K781602) | Anaerobe Systems | 1978-10-10 |
| PRINTER, DIGITAL (K781115) | Output, Inc. | 1978-10-06 |
| ANTIBIOTIC NEPHELOMETER (K781644) | Biovation, Inc. | 1978-10-03 |
| PARALLEL BLADE MARKER (K780991) | Nestor Engineering Associates, Inc. | 1978-10-03 |
| DEVIN-NESTOR SQUARE KNIFE (K780989) | Nestor Engineering Associates, Inc. | 1978-10-03 |
| BECKMAN ASTRA SYSTEM (K781442) | Beckman Instruments, Inc. | 1978-10-03 |
| AUTOMATED ENZYMATIC TRIGLYCERIDE REAGENT (K781466) | Fisher Scientific Co., LLC | 1978-10-03 |
| MINI-KEM (K781576) | Coulter Electronics, Inc. | 1978-10-03 |
| MICRODILUTION GRAM-NEGATIVE ID. PANEL (K781368) | Cnr Labs | 1978-10-03 |
| MOTOR RISER TOLIT LIFT (K781614) | Motor Riser Chairs , Ltd. | 1978-10-03 |
| ENZAC INCUBATOR (K781501) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-10-03 |
| SMA/GGT (K781533) | Technicon Instruments Corp. | 1978-10-03 |
| ACID FAST KIT (K781643) | Bioscientific | 1978-10-03 |
| MICRODILUTION STREP ID. PANEL (K781367) | Cnr Labs | 1978-10-03 |
| EPPENDORF PCP 6121 (K781544) | Marilyn L. Amick | 1978-10-03 |
| DEVIN-NESTOR PNEUMATIC TOURNIQUET (K780988) | Nestor Engineering Associates, Inc. | 1978-10-03 |
| MEPA-1 BLOOD ANALYZER (K781606) | Medico Electronic, Inc. | 1978-10-03 |
| MICRODILUTION ANAEROBE ID. PANEL (K781369) | Cnr Labs | 1978-10-03 |
| TRIGLYCERIDES TEST KIT (K781477) | Mallinckrodt Critical Care | 1978-10-03 |
| BRUSH, APPLICATOR (K781098) | 3M Company | 1978-09-29 |
| EMIT MCA PROGRAM TAPE (K781081) | Instrumentation Laboratory CO | 1978-09-27 |
| THREADED ROD CLAMP (K781447) | Orthopedic Equipment Co., Inc. | 1978-09-27 |
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Every clearance here is in the API, with alerts when new ones post.