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32,815 FDA 510(k) clearances · Device class

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RecordFirmDate
ROCHE REAGENT FOR MAGNESIUM (K901758)Roche Diagnostic Systems, Inc.1990-05-23
URIC ACID TEST KIT (K901001)Elite Technology, Inc.1990-05-23
WIDEX HEARING AID MODEL THE DISCOVERY (K901642)Widex Hearing Aid Co., Inc.1990-05-23
NUCLEAR MAX (K900773)Scientific Imaging, Inc.1990-05-23
BTE SUPER-FRONT PPCL4, SUPER-FRONT PPC4 (K900830)Phonak, Inc.1990-05-23
MIRACLE EAR MODEL PC PROG. IN-THE-EAR HEARING AID (K897035)Miracle-Ear, Inc.1990-05-23
PHONAK ITE 8000, 7000, 6000 ITE HEARING AID (K900675)Phonak, Inc.1990-05-23
BTE PICO SCD, PICO SC (K900831)Phonak, Inc.1990-05-23
MODEL 366 HEARING AID (K900846)Telex Communications, Inc.1990-05-23
WIDEX BTE HEARING AID MODEL Q16 WITH REMOTE (K897033)Widex Hearing Aid Co., Inc.1990-05-23
FLUOR-I-CHAINS(TM) AND FLUOR-I-TIES(TM) (K900824)Midwest Orthodontic Mfg.1990-05-22
KLEIN MICRO-CANNULA HANDLE(TM) (K901719)Jeff Klein Surgical, Inc.1990-05-22
THE TONGUE BRUSH (K901408)Garry Laboratories, Inc.1990-05-21
OMNIPATCH (K900941)Eye Garter Company, Inc.1990-05-21
SIEMENS MODEL 284 PP-L (K893573)Siemens Hearing Instruments, Inc.1990-05-21
SIEMENS MODEL 283 ASP (K893575)Siemens Hearing Instruments, Inc.1990-05-21
PATHO DX STREP D (K902038)Diagnostic Products Corp.1990-05-21
PATIENT EXAM GLOVES (MFG. KOON SENG) (K893071)Innovative Medical Suppliers1990-05-21
SIEMENS MODEL 284 PP-AGC (K893574)Siemens Hearing Instruments, Inc.1990-05-21
SIEMENS MODEL 284 PP (K893576)Siemens Hearing Instruments, Inc.1990-05-21
CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST (K901243)Cel Labs Pty, Ltd.1990-05-21
DESERET MULTILUMEN SUBCLAVIAN CATHETER (K895735)Deseret Medical, Inc.1990-05-18
LATEX PATIENT EXAMINATION GLOVES (K900119)Cen Tex Industrial Co., Ltd.1990-05-18
PATIENT EXAM GLOVES (MFG. SUN FLOWER GLOVE CO.) (K893072)Innovative Medical Suppliers1990-05-18
PATIENT EXAMINATION GLOVES (K901903)Southland Products Co., Ltd.1990-05-18
LATEX PATIENT EXAMINATION GLOVES (K902017)Taksin Rubber Industries Co., Ltd.1990-05-18
LATEX PATIENT EXAMINATION GLOVE (K901855)Tower Marketing Sdn. Bhd.1990-05-18
FRANK INHALER THERMAL S (K895115)Buttner-Frank GmbH1990-05-18
PATIENT EXAMINATION GLOVES (LATEX) (K892305)Hemipan Trading & Mfg. Co. (P) , Ltd.1990-05-18
FERRIS HYDROPHILIC DRESSING (ADD'L INDICATIONS) (K900127)Ferris Mfg. Corp.1990-05-18
MICROPLATE REAGENT DISPENSER (K900599)Denley Instruments, Inc.1990-05-17
IRON/TOTAL IRON BINDING CAPACITY (K901561)Tech-Co, Inc.1990-05-17
LATEX SURGEON GLOVES (K901398)Sinochem (Usa), Inc.1990-05-16
MODIFIED AOR-SULLIVAN PROTECTIVE OVERGLOVE (K902016)Aor-Sullivan1990-05-16
EPI DENT TOOTHBRUSH (K900766)Epi Mfg.1990-05-15
TELEDYNE GETZ'S DISPOSABLE PROPHY ANGLE (K901239)Teledyne Getz1990-05-15
VISUWELL(R) CHLAMYDIA (K900973)Adi Diagnostics, Inc.1990-05-15
ASO-CUBE(TM) (K901371)Difco Laboratories, Inc.1990-05-15
SUNGLASSES (K901047)Command Marketing Corp.1990-05-15
CELEBRITY-CARENZA-SUNGEAR-SUMMIT SUNGLASSES (K901299)Sun Mark, Inc.1990-05-15
SUNPAK AQUA FLOSS 2000 CORDLESS PERSONAL ORAL JET (K900991)Tocad America, Inc.1990-05-15
DU PONT LINX LASER IMAGER W/THE LINX NETWORKING (K900935)E.I. Dupont DE Nemours & Co., Inc.1990-05-15
NON-PRESCRIPTION SUNGLASSES (K901168)Renauld Intl. , Ltd.1990-05-15
PUREBRUSH ULTRAVIOLET TOOTHBRUSH SANITIZER (K896481)Purebrush Assoc.1990-05-15
WAKO(TM) AUTOKIT URIC ACID (K901544)Wako Chemicals USA, Inc.1990-05-14
THE KIRSCHNER UNIVERSAL POWER TOOL SYSTEM (K901455)Kirschner Medical Corp.1990-05-14
CHEM I CLINICAL ANALYZER URINE MAGNESIUM (K901124)Technicon Instruments Corp.1990-05-14
KLEIN CONNECTOR(TM) (K901716)Jeff Klein Surgical, Inc.1990-05-11
VITEK ANAEROBE IDENTIFICATION CARD (K900996)Vitek Systems, Inc.1990-05-11
KLEIN CORK(TM) (K901715)Jeff Klein Surgical, Inc.1990-05-11
TESTPACK PLUS STREP A (K901274)Abbott Laboratories1990-05-11
MPR-4A - MICRO-PLATE READER (K901965)Tosoh Corp.1990-05-10
MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT NO.MB1050 (K901345)Medix Biotech, Inc.1990-05-10
GABRIEL MEDICAL CLS THERMAL RECORDER (K901385)Gabriel Medical, Inc.1990-05-09
SURGICAL RETENTION BAR (K902001)Acufex Microsurgical, Inc.1990-05-09
THERMO-5000 (K895358)Medtronix Ltd., Inc.1990-05-07
INAMED SMALL DRAIN SYSTEM (K901742)Inamed Development Co.1990-05-07
HPI ORTHO SURGEONS' GLOVE (K894828)Tillotson Rubber Co., Inc.1990-05-07
MIRROR SHIELD (K901053)Pulpdent Corp.1990-05-07
INAMED CONVERTIBLE DRAIN SYSTEM (K901764)Inamed Development Co.1990-05-07
FLEXILOG 1010 AMBULATORY PH MONITORING SYSTEM (K896288)Oakfield Instruments, Ltd.1990-05-04
MODEL F 1 FLIP-UP SUNGLASSES W/POLORIZED LENS (K900526)J & B Assoc.1990-05-03
KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE (K900903)Milex Products, Inc.1990-05-03
RICHARD-ALLAN VESSEL LOOPS (K900566)Richard-Allan Medical Ind., Inc.1990-05-03
MODEL 9018 PC SUNGLASSES W/POLYCARBONATE LENSES (K900529)J & B Assoc.1990-05-03
CHLAMYDIAZYME DIAGNOSTIC KIT (K900543)Abbott Laboratories1990-05-03
MODEL N742 SUNGLASSES W/POLYCARBONATE BLUE BLOCKER (K900521)J & B Assoc.1990-05-03
INSTANT ICE PACK (K901834)Impact Packaging Corp.1990-05-03
CHILDREN'S SUNGLASSES (K901468)M. & S. Shillman, Inc.1990-05-03
MODEL N742 SUNGLASSES W/ACRYLIC NIGHT DRIVER LENS (K900520)J & B Assoc.1990-05-03
MODEL S139029 SUNGLASSES W/MIRROR ACRYLIC LENSES (K900527)J & B Assoc.1990-05-03
MODEL N741 SUNGLASSES W/ACRYLIC BLUE COMPUTER LENS (K900522)J & B Assoc.1990-05-03
MODEL F3 FLIP UP SUNGLASSES W/POLORIZED COMPUTER (K900524)J & B Assoc.1990-05-03
MODEL 8806 SD SUNGLASSES W/ACRYLIC LENSES (K900528)J & B Assoc.1990-05-03
OLYMPUS INORGANIC PHOSPHORUS (2-REAGENT MODIFICA.) (K901807)Em Diagnostic Systems, Inc.1990-05-02
OPERAND* LUBRICATING JELLY (K900110)General Medical Co.1990-05-02
LATEX PATIENT EXAMINATION GLOVES (K901750)Haikou Latex Factory1990-05-02
AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM (K901674)Tosoh Corp.1990-05-02
ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE (K897078)Gen-Probe, Inc.1990-05-02
LYPHOCHEK URINE TOXICOLOGY CONTROL - SCREEN (K901270)Bio-Rad1990-05-02
COLORIMETRIC CHLORIDE PRODUCT #4314125 (K900827)American Research Products Co.1990-05-02
DYNA-FLO URINARY DRAINAGE BAG (K896695)Medline Industries, Inc.1990-05-02
SOLAR SHADES(TM) SUNGLASSES (K901161)Blublocker Corp.1990-05-01
3M HEAT COMFORT PORTABLE SELF-HEATING PAD (K901778)3M Company1990-05-01
LIG/TDM A, B, C (K901212)Ciba Corning Diagnostics Corp.1990-05-01
RADIATION PROTECTION GLASSES (K900970)Infab Corp.1990-05-01
DILECTRON URINARY CONDUCTIVITY PROBE (K891681)Gyrus Medical , Ltd.1990-05-01
RADIATION PROTECTION GLOVES (K900972)Infab Corp.1990-05-01
DISCRETION, IN THE CANAL HEARING INSTRUMENT (K896995)Gn Danavox, Inc.1990-04-30
NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE (K897154)Nicolet Instrument Corp.1990-04-30
AMALGAM CONDENSER (K901178)American Medical Ceramics, Inc.1990-04-27
SEARS MODEL 9098 ITE HEARING AID (K901351)Miracle-Ear, Inc.1990-04-27
CHEM-SLEEVE (K901629)Haz-Med, Inc.1990-04-27
SEARS MODEL 9094 ITE HEARING AID (K901350)Miracle-Ear, Inc.1990-04-27
APOLIPOPROTEIN A-I (APO A-I) (K901675)Sigma Chemical Co.1990-04-26
TECHNICON TESTPOINT(TM) LIGAND CONTROL (K900717)Technicon Instruments Corp.1990-04-26
TELEMETRY POWER PACK MODEL 2 (K891927)Lucas & Rhea Mfg.1990-04-26
E/LUMINA(TM)/ALLEGRO LITE(TM) LUMINESCENCE MEASURE (K901542)Source Scientific Systems, Inc.1990-04-26
AMBU OXYGEN REGULATOR (K901623)Flotec, Inc.1990-04-26
STAINLESS STEEL DENTAL WIRES AND CLASPS (K901024)Ivoclar North America, Inc.1990-04-25
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