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32,815 FDA 510(k) clearances · Device class
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| Record | Firm | Date |
|---|---|---|
| INNOTRON FLUORIMETER SERIES ONE-10 (K822942) | Innotron of Oregon, Inc. | 1982-12-09 |
| HEARING AID HB-33 RIONET (K823383) | Kindel & Anderson | 1982-12-09 |
| MICROSURGICAL GAUGE (K823436) | Treace Medical, Inc. | 1982-12-09 |
| HEARING AID HB-72 RIONET (K823384) | Kindel & Anderson | 1982-12-09 |
| ANTIBODY TO MUMPS VIRUS IFA TEST (K822826) | Electro-Nucleonics Laboratories, Inc. | 1982-12-03 |
| BLOOD GAS EXPER. SYSTEM 8700 (K822778) | Exper Corp., Inc. | 1982-12-03 |
| MYCAREL AGAR MYCOBROTIC AGAR (K823308) | Troy Biologicals, Inc. | 1982-12-03 |
| HERPES TRANSETTE (K823443) | Spectrum Diagnostic, Inc. | 1982-12-03 |
| SCHAEDLER AGARS (K823248) | Granite Diagnostics, Inc. | 1982-12-03 |
| MYCOTRIUM-RS (K822737) | Hana Biologics, Inc. | 1982-12-03 |
| CAP-RIA 16 (K823240) | Capintec, Inc. | 1982-12-03 |
| OCTAPETTES (K823137) | Corning Costar Corp. | 1982-12-03 |
| STAX FINGER SPLINTS (K823393) | Orthopedic Systems, Inc. | 1982-12-03 |
| STERILE WATER SYSTEM (K823230) | Syntex Dental Products, Inc. | 1982-12-03 |
| MYCOTRIUM-GU (K822736) | Hana Biologics, Inc. | 1982-12-03 |
| WALKING HEEL (K823394) | Orthopedic Systems, Inc. | 1982-12-03 |
| MODELS G6H, G6T, G1H & G1T (K823460) | Widex Hearing Aid Co., Inc. | 1982-12-03 |
| ELASTIC COMPRESSION ANKLET (K823350) | Podiatry Products Corp. | 1982-12-03 |
| EBV-M KIT (K822985) | Litton Bionetics | 1982-12-03 |
| TRACTION-STEEL FRAMING SYSTEM (K823395) | Orthopedic Systems, Inc. | 1982-12-03 |
| LAKED BLOOD AGAR W/PAROMOMYCIN & VANCOM (K823122) | Granite Diagnostics, Inc. | 1982-12-03 |
| MODEL H 37E (K823468) | Marcon Hearing Instruments, Inc. | 1982-12-03 |
| HEARING AID #G6H & G6T (K823431) | Widex Hearing Aid Co., Inc. | 1982-12-03 |
| AGAR P (K823102) | Dms Laboratories | 1982-12-03 |
| IRRIGATION SET (K822560) | Utah Medical Products, Inc. | 1982-12-03 |
| SMITH'S MEDIUM (K823139) | Granite Diagnostics, Inc. | 1982-12-03 |
| OCTAGONAL ALUMINUM FRAMING SYSTEM (K823372) | Orthopedic Systems, Inc. | 1982-12-03 |
| OXYGEN MASKS (K823141) | Seven Harvest Intl. Import & Export | 1982-11-29 |
| CELL SCRAPER (K823138) | Corning Costar Corp. | 1982-11-29 |
| ANATOMIC FRACTURE BRACE (K823397) | Orthopedic Systems, Inc. | 1982-11-29 |
| ADVANCE EMIT-CAD PROCAINAMIDE/N-ACETYL (K823127) | Syva Co. | 1982-11-29 |
| HEARING AID UE-10-H (K823366) | Unitron Industries, Inc. | 1982-11-29 |
| SBA 300 CLINICAL CHEMISTRY ANALYZER (K823233) | Gilford Instrument Laboratories, Inc. | 1982-11-29 |
| COVER LIMB (K823399) | Orthopedic Systems, Inc. | 1982-11-29 |
| FREE FLEX HEEL HEIGHT ADJUSTOR (K823396) | Orthopedic Systems, Inc. | 1982-11-29 |
| SPECIAL CONTROL SERUM FOR HDL-CHOLES (K823196) | Boehringer Mannheim Corp. | 1982-11-29 |
| MODEL WHO1 HEARING AID (K823285) | Panasonic Co. Div. Matsu Elec. Corp. America | 1982-11-29 |
| 125 I-DEHYDROEPIANDROSTERONE SULFATE (K823200) | Wien Laboratories, Inc. | 1982-11-29 |
| FOREARM REDUCTION UNIT (K823392) | Orthopedic Systems, Inc. | 1982-11-29 |
| OXYGEN TUBINGS (K823142) | Seven Harvest Intl. Import & Export | 1982-11-29 |
| CLINISTAT TDA SERIES (K823112) | Miles Laboratories, Inc. | 1982-11-29 |
| SARTOPHOR SYSTEM FOR ELECTROPHORESIS (K823132) | Sartorius Filters, Inc. | 1982-11-27 |
| DENTAL INSTRUMENTS - CUTTING INSTRUMENT (K823326) | Miltex, Inc. | 1982-11-24 |
| DENTAL INSTRUMENTS - PROBES (K823324) | Miltex, Inc. | 1982-11-24 |
| DENTAL INSTRUMENTS - FILES (K823316) | Miltex, Inc. | 1982-11-24 |
| DENTAL INSTRUMENTS - EXCAVATORS (K823318) | Miltex, Inc. | 1982-11-24 |
| DENTAL INSTRUMENTS - BONE CHISELS (K823320) | Miltex, Inc. | 1982-11-24 |
| MINGOCARD 7 & MINGOPHONE 7 (K822983) | Siemens Corp. | 1982-11-24 |
| DENTAL INSTRUMENTS - KNIVES (K823315) | Miltex, Inc. | 1982-11-24 |
| MODEL 525 NEO-TRAK NEONATAL RECORDER (K823210) | Ge Medical Systems Information Technologies | 1982-11-24 |
| DENTAL INSTRUMENTS - PLASTIC INSTRUMENTS (K823323) | Miltex, Inc. | 1982-11-24 |
| DENTAL INSTRUMENTS - SCALERS (K823319) | Miltex, Inc. | 1982-11-24 |
| DENTAL INSTRUMENTS - CARVER (K823321) | Miltex, Inc. | 1982-11-24 |
| DENTO SPRAY ORAL IRRIGATOR (K823305) | Neo-Life Co. of America | 1982-11-24 |
| DENTAL INSTRUMENTS - PLUGGERS (K823322) | Miltex, Inc. | 1982-11-24 |
| DENTAL INSTRUMENTS - SURGICAL FORCEPS (K823325) | Miltex, Inc. | 1982-11-24 |
| DENTAL INSTRUMENTS (K823314) | Miltex, Inc. | 1982-11-24 |
| SN-100 DOCTOR'S ROUND (K823226) | Kells Medical, Inc. | 1982-11-22 |
| NYSTYMOGRAPH ACCESS (K823111) | Kelleher Corp. | 1982-11-22 |
| ARRIRM SCRUB BRUSH/SPONGE (K823173) | The Buckeye Cellulose Corp. | 1982-11-22 |
| DISTAFLEX (K823280) | Duradent Corp. | 1982-11-22 |
| IMS HEMATOLOGY MIXER (K823124) | Innovative Medical Systems, Inc. | 1982-11-22 |
| CHOLESTEROL HIGH SENSIT. REAGENT ENZYM (K823187) | Rai, Inc. | 1982-11-22 |
| ENT TREATMENT UNITS (K822252) | Kelleher Corp. | 1982-11-22 |
| DENTAL FLOSS TIP (K823278) | Sanderson Creative Products Co. | 1982-11-22 |
| SA-21 DENTAL UNIT (K823180) | Ritter Co. | 1982-11-22 |
| HEARING AID UE-10 (K823365) | Unitron Industries, Inc. | 1982-11-22 |
| RAICHEM & GT REAGENT (K823090) | Reagents Applications, Inc. | 1982-11-22 |
| AIR FLOW I (K823133) | Healthco, Inc. | 1982-11-17 |
| HEAVY-DUTY I.V. STAND (K823270) | E.F. Brewer Co. | 1982-11-17 |
| STREP SELECTIVE AGAR (K822997) | Granite Diagnostics, Inc. | 1982-11-17 |
| ROTARY VASCULAR KNIFE (K822829) | Medco Products, Co., Inc. | 1982-11-17 |
| JORDANS TARTRATE AGAR (K822996) | Granite Diagnostics, Inc. | 1982-11-16 |
| ANDRADES FERMENTATION MEDIA (K822995) | Granite Diagnostics, Inc. | 1982-11-16 |
| PEPTONE IRON AGAR (K823001) | Granite Diagnostics, Inc. | 1982-11-16 |
| MICROFLUOR B PLATE & MICRO FLUOR W PLATE (K822960) | Dynatech Corp. | 1982-11-16 |
| CIN AGAR MEDIUM (K823050) | Gibco Laboratories Life Technologies, Inc. | 1982-11-16 |
| THERMAX; THERMAX SYSTEM (K823245) | American Thermometer Company, Inc. | 1982-11-16 |
| DISPOSABLE DISPENSE MANIFOLD (K823218) | Dynatech Laboratories, Inc. | 1982-11-16 |
| MACATE BROTH (K823000) | Granite Diagnostics, Inc. | 1982-11-16 |
| MODEL SA-1 STETHOSCOPE AUDIO AMPLIFIER (K823126) | Electromedics, Inc. | 1982-11-16 |
| MICROSURGICAL INSTRUMENTS (K823174) | Concept, Inc. | 1982-11-16 |
| U-WAY QUICKOLLAR (K823247) | Ems Industries, Inc. | 1982-11-16 |
| DNASE TEST AGAR W/TOLUIDINE BLUE (K822999) | Granite Diagnostics, Inc. | 1982-11-16 |
| CHRISTENSENS CITRATE SULFIDE AGAR (K822998) | Granite Diagnostics, Inc. | 1982-11-16 |
| BRACE-UP ALL PURPOSE WRIST BAND (K823113) | Arco Matic, Inc. | 1982-11-16 |
| WRIST SPLING & FOREARM SPLINT (K823165) | Warm & Form, Orthopedic Materials | 1982-11-16 |
| CHLAMYDIA TRANSETTEE 1 & 3 (K823179) | Spectrum Co. | 1982-11-16 |
| MICROFLUOR B REMOVAWELL STRIPS (K822962) | Dynatech Corp. | 1982-11-16 |
| ABDOMINAL BINDER (K823164) | Warm & Form, Orthopedic Materials | 1982-11-16 |
| RAPID PRESUMPTIVE IDENT. GPA STREP (K823198) | Microchemical Specialities, Co. | 1982-11-16 |
| QAP MICROCOMPUTER SYSTEM (K823110) | American Dade | 1982-11-16 |
| MICROTECH BACTERIAL CONTROLS (K822954) | Universal Micro Reference Laboratory | 1982-11-16 |
| CORN MEAL AGAR W/POLYSORBATE 80 (K822994) | Granite Diagnostics, Inc. | 1982-11-16 |
| BACTEC NAP TB DIFFERENTIATION TEST (K822946) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-11-12 |
| UNIVERSAL BUCKS TRACTION (K823163) | Warm & Form, Orthopedic Materials | 1982-11-10 |
| PELVIC TRACTION BELT (K823166) | Warm & Form, Orthopedic Materials | 1982-11-10 |
| CERVICAL COLLAR (K823161) | Warm & Form, Orthopedic Materials | 1982-11-10 |
| UNIVERSAL SLING, SLING & SWATHE (K823162) | Warm & Form, Orthopedic Materials | 1982-11-10 |
| DELUXE KNEE IMMOBILIZER (K823159) | Warm & Form, Orthopedic Materials | 1982-11-10 |
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Every clearance here is in the API, with alerts when new ones post.