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

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RecordFirmDate
COURIER II (K953514)Gammex, Inc.1995-10-07
UNITRON MODEL IKON AOHPD (K953727)Unitron Industries, Inc.1995-10-07
LD GENERAL PURPOSE DISINFECTANT (K952929)Alcide Corp.1995-10-07
OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP (K953290)Olympus America, Inc.1995-10-07
UNITRON MODEL SOUND F/XD (K953932)Unitron Industries, Inc.1995-10-07
MIRACLE - EAR MODEL PBP (K954528)Miracle-Ear, Inc.1995-10-07
AALTO SCIENTIFIC LIQUID CARDIAC CONTROL (K954074)Aalto Scientific, Ltd.1995-10-07
CHLAMYDIA OIA (K951010)Biostar, Inc.1995-10-07
OPUS HCG CONTROLS (K954144)Behring Diagnostics, Inc.1995-10-06
CLM LARYNGOSCOPE (K953179)Penlon , Ltd.1995-10-06
UNITRON MODEL SOUND F/X (K954430)Unitron Industries, Inc.1995-10-06
UNISCAN (K953398)Merlin Engineering Works, Inc.1995-10-06
TOX PERFECT A TUBE (K953393)Chimera Research & Chemical, Inc.1995-10-06
DEROYAL INDUSTRIES, INC. POLYDERM & POLYDERM BORDER FOAM WOUND DRESSINGS (K953403)Deroyal Industries, Inc.1995-10-06
W&H 100 SERIES LOW SPEED (K944719)A-Dec, Inc.1995-10-05
W&H ROTO QUICK COUPLINGS (K945734)A-Dec, Inc.1995-10-05
FLEXMATE K500 (K950755)Breg, Inc.1995-10-05
INSTANT COLDGEL (K953541)Prism Technologies, Inc.1995-10-05
MICRO-TOUCH* LATEX SURGICAL GLOVES (K954049)Johnson & Johnson Medical, Inc.1995-10-05
W&H 900 INCOLIGHT LT HANDPIECE (K944718)A-Dec, Inc.1995-10-05
FIRST RESPONSE OVULATION PREDICTOR TEST (K953581)Armkel, LLC1995-10-03
SPECTACLE SUN GLASSES (NON PRESCRIPTION) (K954173)Monte Carlo Eyewear, Inc.1995-10-03
KENSORB (K953830)Kentron Health Care, Inc.1995-10-03
CALVITRON HAIR TRANSPLANT SYSTEM (K952737)Medicamat S.A.1995-10-03
ABBOTT IMX PROLACTIN(MODIFICATION) (K953656)Abbott Mfg., Inc.1995-10-03
ULTRA-SENSITIVE ESTRADIOL (K953605)Diagnostic Systems Laboratories, Inc.1995-10-02
GAUZE SPONGE (K953812)Remington Medical, Inc.1995-10-02
OCTOROLL (K953246)Octostop, Inc.1995-09-29
COMFEEL:ALGINATE DRESSING (K953497)Coloplast A/S1995-09-29
DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF (K953953)Deroyal Industries, Inc.1995-09-29
VOXGRAM (K954200)Voxel1995-09-29
EXSPOR (K953241)Alcide Corp.1995-09-29
SPIN ROLLERE (K952990)Kinsei Shiatsu, Inc.1995-09-29
SKIN SAVER SYSTEMS (K952738)Skin Saver Systems, Inc.1995-09-29
MULLAN GANGLION MICROCOMPRESSION SET (K940973)Cook, Inc.1995-09-29
VOXBOX (K954199)Voxel1995-09-29
CIT BIOPSY PUNCHES (K944444)Chirurgische Instrumente1995-09-29
PROPHY ANGLE (K953628)Rolence Enterprise Co. , Ltd.1995-09-29
DIGITAL IMAGING SYSTEM INTERFACE (K953080)Camtronics, Ltd.1995-09-28
3M MODEL 8295 (K954067)3M Company1995-09-28
MAICO PRODIGY CIC SERIES (K954054)Maico Hearing Instruments, Inc.1995-09-28
BILI-METER (K953005)Olympic Medical Corp.1995-09-28
SHAPING HEDSTROM N.T. (K953604)Sybron Dental Specialties, Inc.1995-09-28
UNSCENTED CURVED MAXI PAD (K953700)Paragon Trade Brands, Inc.1995-09-27
UNSCENTED MENSTRAL PAD WITH WINGS (K953666)Paragon Trade Brands, Inc.1995-09-27
HYPOALLERGENIC POWDERED AMBIDEXTROUS COAGULATN DIPPED LATEX EXAMINATION GLOVE (K953379)Ansell, Inc.1995-09-27
Q5. 5-5.5NPB-2.5HW (K954292)Central Solutions, Inc.1995-09-27
E. COLI 0157 ELISA STOOL ASSAY (K942705)Lmd Laboratories1995-09-27
HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR (K953582)Varian Canada, Inc.1995-09-26
SILK*SKIN SCAR TREATMENT (K953420)Silk*Skin Care Co.1995-09-26
AUKULYTE (K953610)Aukland Medical Plastics, Inc.1995-09-26
ACTI-FLEX ARTERIAL EXTENSION SET (K954035)R-Group Intl.1995-09-25
EBV-VCA IGM ELISA TEST STSTEM (K944449)Zeus Scientific, Inc.1995-09-25
HEMA-TROL Q-CHECK (K952385)Medical Specialties Intl., Inc.1995-09-25
BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER (K953239)Boehringer Mannheim Corp.1995-09-25
ACCESS ULTRASENSITIVE INSULIN ASSAY (K953084)Bio-Rad Laboratories, Inc.1995-09-25
ABBOTT AXSYM PROLACTIN(MODIFICATION) (K953657)Abbott Mfg., Inc.1995-09-25
WELCH ALLYN VIDEO EPISCOPE (K952835)Welch Allyn, Inc.1995-09-22
MEDI-PLUS, HEALTH PLUS, SANITEX, RELIANCE (K953138)Pwa Industries Sdn. Bhd.1995-09-22
QUICK READ 2000 (QR2000) (K953163)Quicksilver Systems, Inc.1995-09-22
ILIAC CREST BONE MARROW ASPIRATION NEEDLE (K953082)Baxter Healthcare Corp1995-09-22
ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE (K950803)Isolab, Inc.1995-09-21
JT-3 ELECTROGNATHOGRAPH (K952218)Bio-Research Associates, Inc.1995-09-21
CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE (K952427)Beckman Instruments, Inc.1995-09-21
IRON/TIBC REAGENT (K935712)Horizon Diagnostics, Inc.1995-09-20
ABUSCREEN ONLINE CONTROLS (K953739)Roche Diagnostic Systems, Inc.1995-09-20
ABUSCREEN ONLINE DRUG FREE URINE (K953845)Roche Diagnostic Systems, Inc.1995-09-20
UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS (K953786)Unicor, Inc.1995-09-19
UNICOR, INC. GAS SAMPLING LINES & CONNECTORS (K953788)Unicor, Inc.1995-09-19
EBNA IGG ELISA TEST (K935730)Gull Laboratories, Inc.1995-09-19
UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT (K953787)Unicor, Inc.1995-09-19
AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS (K940320)Ad-Tech Medical Instrument Corp1995-09-19
STOMAVISION (STV) (K951074)Trophy Radiologie1995-09-19
DISPOSABLE, CPAP OXYGEN MASK (K945482)Fvtnks1995-09-19
LIFE SOUND SENSOR (K952651)Flowscan, Inc.1995-09-19
MEDICAL MIXTURE-LUNG DIFFUSION GAS MIXTURES (K952838)Standard Welders Supply Co.1995-09-19
UNICOR, INC. CORRUGATED TUBING (K953784)Unicor, Inc.1995-09-19
OLYMPUS IMAGEMANAGER SYSTEM VERSION 6.0 FOR WINDOWS (K952888)Olympus America, Inc.1995-09-18
UNICOR, INC. VENTILATOR HOSES (K953785)Unicor, Inc.1995-09-18
REXTON MINI-PRIMO PLUS, PP142, D.C .H.I. FAMILY (K953770)Rexton, Inc.1995-09-18
AMENDMENTS TO MULTIFOCUS (K951002)Oticon A/S1995-09-18
STAR TECHNOLOGIES, INC. FILM IMAGE SCAN SYSTEM (K952914)Star Technologies, Inc.1995-09-18
PHONAK 9900 CIC (K953921)Phonak, Inc.1995-09-18
WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK (K953464)Westmed, Inc.1995-09-18
MED-TECH LUNG DIFFUSION MIXTURE (K953934)Medical Technical Gases Inc..1995-09-18
K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING INSTRUMENT (K954038)Argosy Electronics1995-09-18
TOMTECP90 (K950279)Tomtec Imaging Systems, Inc.1995-09-15
APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT (K950383)Randox Laboratories, Ltd.1995-09-15
PRENVAL I (K953652)Base Ten Systems, Inc.1995-09-15
HEAT MOISTURE EXCHANGER (K953580)Intertech Resources, Inc.1995-09-15
APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT (K950382)Randox Laboratories, Ltd.1995-09-15
HAMEX ONE (K951029)Northern Orthopaedic Products, Inc.1995-09-15
MIDAS REX TELESCOPING SYSTEM (K953433)Midas Rex Pneumatic Tools, Inc.1995-09-15
ENDOCYTE TM (K944238)D.L. Nelson and Assoc., Inc.1995-09-15
WESTMED RESPIRATORY LUER ADAPTOR (K953506)Westmed Intl.1995-09-15
HYDROPHILIC FOAM DRESSING (K953019)Busse Hospital Disposables, Inc.1995-09-15
MAXXUS ORTHOPAEDIC SURGICAL GLOVES (K953641)Johnson & Johnson Medical, Inc.1995-09-15
EBV-EA(D) IGG ELISA TEST (K940093)Gull Laboratories, Inc.1995-09-15
VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS (K953039)Dadsun Corp., Ltd.1995-09-15
AQUAHAB, MODEL 120-72-101 (K945733)Aquarius Electronics, Inc.1995-09-15
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