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32,815 FDA 510(k) clearances · Device class
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| Record | Firm | Date |
|---|---|---|
| AXICUT DISPOSABLE SCALPEL (K811707) | Neonatal Corp. | 1981-07-20 |
| DEPUY HEMODRAIN (K811557) | Depuy, Inc. | 1981-07-20 |
| SURGICAL INSTRUMENTS (K811686) | C.V.I., Inc. | 1981-07-20 |
| CRYSTONA (K811754) | Smith & Nephew, Inc. | 1981-07-20 |
| TIP-VU (K811822) | Instranetics, Inc. | 1981-07-20 |
| RETRACTING PROBES (K811759) | American V. Mueller | 1981-07-20 |
| MICRO OSCILLATING SAW (K811834) | Micro-Aire Surgical Instruments, Inc. | 1981-07-20 |
| SHARPS CADDY FB (K811823) | Instranetics, Inc. | 1981-07-20 |
| CAUTERY CADDY PAD (K811824) | Instranetics, Inc. | 1981-07-20 |
| MULTITUBULAR THORACIC AIR SPLINTS (K811750) | Roger Cestac & Assoc. | 1981-07-20 |
| GATOR DRAPES (K811717) | The Anspach Effort, Inc. | 1981-07-20 |
| NORELCO MASSAGER PLUS HEAT BELT (K811891) | North American Philips Corp. | 1981-07-20 |
| UNSCENTED MENSTRUAL PADS (K811869) | Procter & Gamble Mfg. Co. | 1981-07-16 |
| PHOLPHORYL-ASE TUBES (K811853) | Microchemical Specialities, Co. | 1981-07-16 |
| CERVICAL DILATOR (K811568) | Gynemetrics, Inc. | 1981-07-16 |
| REDUCT-ASE TUBES (K811852) | Microchemical Specialities, Co. | 1981-07-16 |
| KHI CPRAM BREATHING CIRCUIT (K811858) | Khi, Inc. | 1981-07-16 |
| GALACTOSID-ASE TUBES (K811854) | Microchemical Specialities, Co. | 1981-07-16 |
| EASY-FLO ARTERIAL BLOOD GAS KIT (K811860) | Dhd Medical Products Div. Diemolding Corp. | 1981-07-16 |
| QUICK-CHEM COLORIMETER (K811806) | The Dow Chemical Co. | 1981-07-15 |
| BILIRUBINOMETER (K811840) | Advanced Instruments, Inc. | 1981-07-15 |
| DISPOSABLE TRACH T OXYGENATOR (K811890) | Airlife, Inc. | 1981-07-15 |
| PARA-PAK (K811722) | Meridian Diagnostics, Inc. | 1981-07-15 |
| THERAPEUTIC DRUG CONTROL (K811756) | Icl Scientific | 1981-07-15 |
| PRECINORM U & PRECIPATH U HUMAN SERUM (K811832) | Boehringer Mannheim Corp. | 1981-07-15 |
| FINETONE MODEL VI HEARING AID (K811751) | Vicon Instrument Co. | 1981-07-15 |
| WATER PISTOL (K811594) | Aus-Tex Dental Mfg. & Design | 1981-07-15 |
| SR-ISOCETTE (K811665) | J. Aderer, Inc. | 1981-07-15 |
| URIC ACID TEST (K811810) | Environmental Chemical Specialties | 1981-07-15 |
| A.D.T. REUSABLE BONE MARROW NEEDLE (K811771) | Lab Industries, Inc. | 1981-07-10 |
| LIGHTNING DIALYZER (K810871) | Clintox Laboratories, Inc. | 1981-07-10 |
| PREP-SITE PROTECTIVE DRESSING WIPE (K811625) | Acme United Corp. | 1981-07-10 |
| CIRCUIT, BREATHING (K811700) | Marquest Medical Products, Inc. | 1981-07-10 |
| ANTI-ARRHYTHMIC CONTROL LEVELS I & II (K811809) | Environmental Chemical Specialties | 1981-07-10 |
| TDM ANTI-CONVULSANT CONTROL LEVELS I-II (K811811) | Environmental Chemical Specialties | 1981-07-10 |
| CHOLESTEROL DETERMINATION (K811760) | Biorent Diagnostic, Inc. | 1981-07-10 |
| EPILATOR, BLEND-MODEL EB-200 & ET-1 (K811503) | Rcx-Western, Inc. | 1981-07-10 |
| SIEMENS ANGIOTRON (K811587) | Siemens Corp. | 1981-07-10 |
| EPILATOR, MULTIPLE NEEDLE-MODEL EM-20 (K811501) | Rcx-Western, Inc. | 1981-07-10 |
| EOSIN Y (K811826) | Surgipath | 1981-07-10 |
| SILASTIC TENDON PASSER H.P. (K811679) | Dow Corning Corp. Healthcare Industries Materials | 1981-07-10 |
| KING DIAGNOSTICS CHOLESTEROL TEST (K811747) | King Diagnostics, Inc. | 1981-07-10 |
| TBG DIAGNOSTIC KIT (K811725) | Immuno Assay Corp. | 1981-07-10 |
| ORANGE G-6 (K811825) | Surgipath | 1981-07-10 |
| KING DIAGNOSTICS PHOSPHORUS TEST (K811749) | King Diagnostics, Inc. | 1981-07-10 |
| SELECT-A-FLOW (K811857) | Wenmar Intl. Corp. | 1981-07-10 |
| PAPER CHART RECORDER (K811254) | American Edwards Laboratories | 1981-07-10 |
| QUANTIMUNE ESTRIOL RIA (K811709) | Bio-Rad | 1981-07-10 |
| NOVATRACER RECORDER (K811453) | Novametrix Medical Systems, Inc. | 1981-07-10 |
| CONFI-DRY ADULT UROABSORBENT PADS (K811766) | Personal Products Co. | 1981-07-10 |
| MRI PROLACTIN RIA KIT (K810949) | Microanalytic Research, Inc. | 1981-07-10 |
| ELECTRONIC APGAR TIMER (K811424) | Pt&E | 1981-07-09 |
| BRAIN HEART INFUSION AGAR (K811654) | Acumedia Manufacturers, Inc. | 1981-07-02 |
| DEXTROSE BROTH (K811731) | Acumedia Manufacturers, Inc. | 1981-07-02 |
| HELENA PLASMINOGEN QUIPLATE PROCEDURE (K811777) | Helena Laboratories | 1981-07-02 |
| THIOTONE PEPTONE (K811732) | Acumedia Manufacturers, Inc. | 1981-07-02 |
| GELYSATE (K811649) | Acumedia Manufacturers, Inc. | 1981-07-02 |
| ECA (K811397) | Gillco, Inc. | 1981-07-02 |
| COLUMBIA AGAR BASE (K811641) | Hardy Media | 1981-07-02 |
| MACCONKEY AGAR (K811643) | Hardy Media | 1981-07-02 |
| BARNES-HIND SPECTACLE LENS CLEANER (K811554) | Barnes-Hind, Inc. | 1981-07-02 |
| EOSIN METHYLENE BLUE AGAR (LEVINE) (K811642) | Hardy Media | 1981-07-02 |
| COLUMBIA (K811729) | Acumedia Manufacturers, Inc. | 1981-07-02 |
| DCLS AGAR (K811736) | Acumedia Manufacturers, Inc. | 1981-07-02 |
| CTA MEDIUM (K811735) | Acumedia Manufacturers, Inc. | 1981-07-02 |
| MEDICASE SOY AGAR (K811640) | Hardy Media | 1981-07-02 |
| BIOSATE (K811730) | Acumedia Manufacturers, Inc. | 1981-07-02 |
| TUNGSTEN SYRINGE SHIELD (K811688) | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1981-07-02 |
| KRYPTON CART (K811677) | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1981-07-02 |
| OECO NASAL CANNULA (K811789) | Oeco | 1981-07-02 |
| AZIDE BLOOD AGAR BASE (K811733) | Acumedia Manufacturers, Inc. | 1981-07-02 |
| ENDO AGAR (K811648) | Acumedia Manufacturers, Inc. | 1981-07-02 |
| GUAMSTAINER (K811697) | Tomtec | 1981-07-02 |
| SALMONELLA-SHIGELLA AGAR (K811647) | Hardy Media | 1981-07-02 |
| POLYPEPTONE PEPTONE (K811652) | Acumedia Manufacturers, Inc. | 1981-07-02 |
| PHYTONE (K811653) | Acumedia Manufacturers, Inc. | 1981-07-02 |
| BRUCELLA BROTH (K811734) | Acumedia Manufacturers, Inc. | 1981-07-02 |
| HEKTOEN ENTERIC AGAR (K811644) | Hardy Media | 1981-07-02 |
| SMR PARAGON CHAIR TABLE (K811623) | Smr | 1981-07-02 |
| MAXI CAMERA/D (K811676) | General Electric Co. | 1981-07-02 |
| MACCONKEY BROTH (K811650) | Acumedia Manufacturers, Inc. | 1981-07-02 |
| TRYPTICASE (K811651) | Acumedia Manufacturers, Inc. | 1981-07-02 |
| MEDDARS/ULTRA IMAGER PULSE/PHON MODULE (K811626) | Honeywell, Inc. | 1981-07-01 |
| DENTAL FLOSS HOLDER (K811555) | Sewon Industry | 1981-07-01 |
| TELESONIC & ARCON (K811031) | Telesonic, Inc. | 1981-07-01 |
| PEDIATRIC OXYGEN MASKS (K811711) | Airlife, Inc. | 1981-07-01 |
| IL #781, SEMI-AUTOMATED LOADER (K811696) | Instrumentation Laboratory CO | 1981-07-01 |
| DAHLBERG MODEL AP HEARING AID (K811578) | Dahlberg Electronics, Inc. | 1981-07-01 |
| HELENA FETAL-TEK 200 MARKER (K811695) | Helena Laboratories | 1981-07-01 |
| MULTITUBULAR AIR SPLINT KIT (K811704) | Roger Cestac & Assoc. | 1981-07-01 |
| CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT (K811694) | Baker Instructions Corp. | 1981-07-01 |
| AQUACADE (K811524) | Respiratory Care, Inc. | 1981-07-01 |
| UNIVERSAL ADAPTER SYSTEM-U/ADAPIT (K811708) | Airlife, Inc. | 1981-07-01 |
| URIC ACID TEST (K811687) | King Diagnostics, Inc. | 1981-07-01 |
| ECCO GENERATOR (K811198) | Philips Medical Systems (Cleveland), Inc. | 1981-06-29 |
| SCEPTOR ID GRAM NEGATIVE MIC/ID PANELS (K811434) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-06-26 |
| ANIS LENS IMPLANT FORCEPS #2 (K811658) | American V. Mueller | 1981-06-26 |
| RE-HP SERIES HEARING AIDS (K811522) | Radioear Corp. | 1981-06-26 |
| RIONET HEARING AID HB-69 (K811531) | Rion Acoustic Instruments, Inc. | 1981-06-26 |
| FORDER RETRACTOR (K811693) | Dacomed Corp. | 1981-06-26 |
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Every clearance here is in the API, with alerts when new ones post.