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

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RecordFirmDate
HIPPURATE TEST DISKS (K842868)Irvine Diagnostic Services1984-08-03
IMMUSTAPH LATEX AGGLUTINATION KIT (K842709)Immucell Corp.1984-08-03
BRAIN HEART INFUSION BROTH (K842852)Anarobe Systems1984-08-03
ZENKERS SOLUTION (K842732)E K Ind., Inc.1984-08-03
SALINE, 0.85%W/PRESERVATIVE (K842725)E K Ind., Inc.1984-08-03
SALINE 0.85% W/O PRESERVATIVE (K842724)E K Ind., Inc.1984-08-03
INDOLE REAGENT (K842872)Irvine Diagnostic Services1984-08-03
VOGES-PROSKAUER REAGENT B (K842867)Irvine Diagnostic Services1984-08-03
BUF-FIX (K842728)E K Ind., Inc.1984-08-03
LYSINE IRON AGAR (K842853)Anarobe Systems1984-08-03
TRYPTICASE SOY BROTH (K842849)Anarobe Systems1984-08-03
CHRISTENSEN'S UREA AGAR (K842855)Anarobe Systems1984-08-03
DECOLORIZING FLUID (K842729)E K Ind., Inc.1984-08-03
HOPPENSTEIN MICROSURGICAL SPINAL INSTRU (K842701)Downs Surgical , Ltd.1984-08-02
ISLAM BONE MARROW ASPIRATION NEEDLES (K842699)Downs Surgical , Ltd.1984-08-02
CHERMEL OSTEOTOMES (K842823)Cher Mel Corp.1984-08-02
CHERMEL BONE CHISELS (K842824)Cher Mel Corp.1984-08-02
CHERMEL BONE GOUGES (K842822)Cher Mel Corp.1984-08-02
POST-AID (K840907)E.W. Link, Inc.1984-08-02
MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT (K842623)Syva Co.1984-08-02
PDA SYSTEM (K842522)Abbott Laboratories1984-08-02
ALLIED ASSOC. THERAPEUTIC EXERCISE (K842433)Allied Associates, Inc.1984-08-02
ROSENBERG SKIN GRAFTING KNIVES (K842702)Downs Surgical , Ltd.1984-08-02
CONFERETTE C2 (K840893)Siemens Hearing Instruments, Inc.1984-08-02
TIDAL DISTENSION IRRIGATION SET (K841362)Abbott Laboratories1984-08-02
SURGICAL HEADLIGHT (K842515)Good-Lite Co.1984-08-02
ALLIED ASSOC. THERAP. EXERCISE EQUIP (K842430)Allied Associates, Inc.1984-08-02
ALLIED ASSOC. THERAPEUTIC EXER EQUIP- (K842429)Allied Associates, Inc.1984-08-02
ALLIED ASSOC. THERAPEUTIC EXERCICE EQUIP (K842428)Allied Associates, Inc.1984-08-01
ALLIED ASSOC. THERAP. EXERCISE EQUIP- (K842431)Allied Associates, Inc.1984-08-01
VACOMED 4 (K842802)Robert Bosch Corp.1984-08-01
PILLOW W/STAPHCHEK TICKING (K842335)Monterey Mills, Inc.1984-08-01
ALLIED ASSOC. THERAPEUTIC EXERCISE EQUIP (K842427)Allied Associates, Inc.1984-08-01
ALLIED ASSOC. THERAPEUTIC EXERICSE (K842426)Allied Associates, Inc.1984-08-01
ALLIED ASSOCIATES THERAPEUTIC EXERSIE (K842432)Allied Associates, Inc.1984-08-01
ALLIED ASSOCIATES THERAPEUTIC EXERCISE (K842425)Allied Associates, Inc.1984-08-01
CROWN INDEX TRAY (K842273)Di-Equi Dental Products1984-07-31
ISOLIGHT (K842358)Planmeca USA, Inc.1984-07-31
F-G-P TRAY (K842274)Di-Equi Dental Products1984-07-31
INFRA-EYE 160 (K841271)Fujitsu , Ltd.1984-07-28
ARM-A-VIAL LV SODIUM CHLORIDE INHALAT (K841989)Armour Pharmaceutical Co.1984-07-27
ARM-A-CARE HUMIDIFIER-RESPIRATORY GAS (K841991)Armour Pharmaceutical Co.1984-07-27
SIRC (K842583)Viromed Laboratories, Inc.1984-07-27
B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONS (K842579)Biological & Environmental Control Laboratories1984-07-27
CODMAN SUCTION PUNCH-PRODUCT CODES (K842774)Codman & Shurtleff, Inc.1984-07-27
ARM-A-CARE NEBULIZER-NEBULIZER (K841990)Armour Pharmaceutical Co.1984-07-27
RESPIRONICS VENT EASY OXYGEN ENRICHME (K842605)Respironics, Inc.1984-07-27
HEK (K842584)Viromed Laboratories, Inc.1984-07-27
HISTOPAQUE-1077 (K842146)Sigma Chemical Co.1984-07-27
SUNGLASSES (K841248)China Toy & Novelty Co., Ltd.1984-07-27
ARM-A-VIAL LV STERIAL WATER FOR INHALA (K841987)Armour Pharmaceutical Co.1984-07-27
MIDAS II AUTOMATIC STAINER (K842077)Innovative Medical Systems, Inc.1984-07-27
ARM-A-VIAL LV SODIUM, CHLORIDE INHALAT (K841988)Armour Pharmaceutical Co.1984-07-27
AVATRON UNIVERSAL ADULT VOL. VENTILATOR (K842778)Avatron, Inc.1984-07-26
CHEMISTRY ANALYZER, GEN. PURPOSE (K842311)Hml Inc/Biotechnology Transfer1984-07-25
CLINITEK 10 SEMI-AUTO URINALYSIS SYS (K842238)Miles Laboratories, Inc.1984-07-25
SYVA IQ 190 DIGITAL PIPETTER DILUTER (K842390)Syva Co.1984-07-25
AXIOM STABLE II CHOLESTEROL TEST (K842441)Axiom, Inc.1984-07-25
FIRST RESPONSE EMERG. MEDICAL SYSTEM (K841897)Reed Products, Inc.1984-07-23
SINGLE HAIR TRANSPLANT GRAFT (K841741)Paris Products, Inc.1984-07-23
SURG-A-STAT VASECTOMY TIP (K840370)Suncoast Medical Manufacturers, Inc.1984-07-23
OXYMIZER FLOW RESTRICTOR (K841901)Chad Therapeutics, Inc.1984-07-23
WIRE (K841628)Plastafil, Inc.1984-07-23
MEDICAL RUBBER GLOVES-STERILE-SURGEONS (K831632)Tagum Rubber Industries, Ltd.1984-07-23
NEUTRAL POS-CHAIR SURGEON CHAIR (K842030)Neutral Pos-Chair Co.1984-07-23
RODY BREAST PUMP (K840874)Kean-Rody Manufacturer1984-07-23
FIRST RESPONSE EMERG. MEDICAL SYS BONES (K841899)Reed Products, Inc.1984-07-23
BECTEC NR-660 BACTERIAL DETECT SYS (K842279)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-07-20
GNC PLUS (K842587)Vitek Systems, Inc.1984-07-20
MINIMUM ESSENTIAL MED. M0769 W/WO (K842672)Sigma Chemical Co.1984-07-20
BASAL MED. EAGLE B8265, W/EARLS SALTS (K842671)Sigma Chemical Co.1984-07-20
CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT (K842151)Bartels Immunodiagnostic Supplies, Inc.1984-07-20
PROXIMA 1 PH MONITOR (K841384)American Endoscopy, Inc.1984-07-19
ULTRA SHIELD BRIEFS (K841953)Ipco Corp.1984-07-19
ELEVATOR (K841356)Treace Medical, Inc.1984-07-18
URIC ACID ASSAY KIT (K842246)Diagnostic Chemicals, Ltd. (Usa)1984-07-18
RHINO-LARYNX STROBOSCOPE TYPE 4914 (K842090)Bruel & Kjaer Industri A/S1984-07-18
ALANINE AMINOTRANSFERASE ASSAY KIT (K842241)Diagnostic Chemicals, Ltd. (Usa)1984-07-18
CONFORMA (K841559)Beiersdorf, Inc.1984-07-17
BRIMFIELD FIBEROPTIC LIGHT SCOURCE (K841731)Brimfield Scientific Instruments1984-07-16
MAXICAMERA 400T W/BODY CONTOUR TOMOGRA (K841996)General Electric Co.1984-07-16
BANANA CUFF (K841558)Aspen Laboratories, Inc.1984-07-16
ATAGO URINE SPECIFIC GRAVITY & SERUM (K842168)Kyoto Diagnostics, Inc.1984-07-16
DISPOSABLE PILLOW (K842336)Monterey Mills, Inc.1984-07-13
DISPOSA-SPEC (K840593)Plasti-Products, Inc.1984-07-13
CONVENTIONAL PLASTIC DENTAL TRAYS (K841491)Buffalo Dental Mfg. Co., Inc.1984-07-13
GENERATED RETINAL REFLEX IMAGERY SYS (K840840)Electro Optical Instruments1984-07-12
RELIABLE (K834479)Reliable Hearing Aide1984-07-11
H-TYPE BRIDGE REMOVER (K842026)Higa Manufacturing , Ltd.1984-07-11
SOFT-TISSUE INSTRUMENT (K841622)Plastafil, Inc.1984-07-11
STREP-A-CHEK (K842600)E-Y Laboratories, Inc.1984-07-11
SLOTTED SOFT-TISSUE INSTRUMENT (K841623)Plastafil, Inc.1984-07-11
DRILL GUIDE (K841619)Plastafil, Inc.1984-07-11
OSTOMY FREEDOM KIT (K841173)Ellenberg Assoc.1984-07-09
VARIAN 3300 & 3400 GAS CHROMATOGRAPHS (K841891)Varian Assoc., Inc.1984-07-09
TRIGLYCERIDES-GPO REAGENT (K842029)Reagents Applications, Inc.1984-07-09
DRYDEN INFLATABLE MASK (K842472)Dryden Corp.1984-07-06
MAXICAMERA 400 AC (K841906)General Electric Co.1984-07-06
ULTRA CHEM ENZYMATIC TRIGLYCERIDE (K842211)Em Diagnostic Systems, Inc.1984-07-06
AMER. MEDICAL PLASTICS CO 20100 (K842492)American Medical Plastics Co.1984-07-06
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