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

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RecordFirmDate
IMPACT AIR 45 4-HOLE (K952927)Palisades Pharmaceutics, Inc.1996-08-06
POWERCUT GOLD SURGICAL SYSTEM (K962022)Baxter Healthcare Corp1996-08-05
TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (K961477)Trace America, Inc.1996-08-05
CHROMAGAR CANDIDA (K960075)Hardy Diagnostics1996-08-02
HEPATITIS NEGATIVE CONTROL (K962399)Pyramid Biological Corp.1996-08-02
CBI 7520 READER (K961183)Columbia Bioscience, Inc.1996-08-02
PHILIPS 71 SERIES (K961770)Philips Hearing Instruments Co.1996-08-02
TECHNICON IMMUNO 1 SYSTEM (K962125)Bayer Corp.1996-08-02
BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM (K962423)Becton Dickinson Microbiology Systems1996-08-02
HYDROGEL SKIN DRESSING (K962352)North American Sterilization & Packaging Co.1996-08-02
EXPANDACELL INJECTO-PAK (K962133)Shippert Medical Technologies Corp.1996-08-01
GENERAL PURPOSE DENTAL TRAY (K962527)Medcare Medical Group, Inc.1996-08-01
ORIGEN ANALYZER (K962166)Igen, Inc.1996-07-31
INFINET (K961689)Infimed, Inc.1996-07-31
DRAGER GEMINA WALL-MOUNTED WORKPLACE (K961886)Alm Surgical Equipment, Inc.1996-07-30
PYLORI IGG ELISA TEST SYSTEM (K961221)Armkel, LLC1996-07-30
ULTRA CARE POWDER FREE HYPOALLERGENIC PATIENT EXAMINATION GLOVE (K960247)Tillotson Healthcare Corp.1996-07-29
POWDER FREE PLUS HYPOALLERGENIC (WITH LABELED PROTEIN CONTENT) PATIENT EXAMINATION GLOVES (K960225)Tillotson Healthcare Corp.1996-07-29
PATIENT EXAMINATION GLOVE (POWDERED) (K954293)Medline Products Co. , Ltd.1996-07-26
COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN) (K962188)Wembley Rubber Products (M) Sdn Bhd1996-07-26
DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM (K961742)Alm Surgical Equipment, Inc.1996-07-26
COMMAND 2 MICOELECTRIC SURGICAL SYSTEM (K961970)Stryker Corp.1996-07-26
COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN) (K962189)Wembley Rubber Products (M) Sdn Bhd1996-07-26
SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP (K962170)Siemens Hearing Instruments, Inc.1996-07-25
MEDSHIELD/AEROCHAMBER (K961455)Diemolding Corp.1996-07-25
CENTER OPTICAL GLASSES (K962298)Mirage Eyewear, Inc.1996-07-25
MLX MICROTITER PLATE LUMINOMETER (K962265)Dynatech Laboratories, Inc.1996-07-25
MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBE (K962688)Boston Medical Products, Inc.1996-07-25
AMMI MAGNI-GUARD (K961454)American Medical Mfg., Inc.1996-07-25
SUNGLASSES (NON-PRESCRIPTION) (K962775)Canadd Trading Co.1996-07-25
SHARED VISION(PART NUMBER SV 0015) (K961753)Imagelabs, Inc.1996-07-25
SOMA (K962725)Soma International , Ltd.1996-07-25
BG PATIENT EXAMINATION GLOVES, NON-STERILE (K961675)Biografik (Malaysia) Sdn Bhd1996-07-25
XIAMEN CHINGSONG OPTICAL INDUSTRIAL CO., LTD. (K962382)Xiamen Chingsong Optical Industrial Co., Ltd.1996-07-25
(BRAND NAME) SUNGLASS FRAMES (K962478)Custom Optical Frames, Inc.1996-07-25
SUNGLASSES, GAUDI SUN LINE (K962636)Gaudi Spa1996-07-25
INCSTAR HSZ I/II IGG ELISA ASSAY (K955363)Incstar Corp.1996-07-24
INCSTAR HSV I/II IGG FAST ELISA ASSAY (K955362)Incstar Corp.1996-07-24
DIAO HAND SURGERY SET (K960539)Kinetikos Medical, Inc.1996-07-23
URIC ACID-SL ASSAY CATALOGUE NO. 237-60 (K961586)Diagnostic Chemicals , Ltd.1996-07-23
ELECSYS PRECICONTROL CARDIAC (K962575)Boehringer Mannheim Corp.1996-07-22
STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY (K954156)Solarcare Technologies Corp,Inc.1996-07-22
DOCUMENT CARDIAC ASSAYED CONTROL (K961750)Casco Standards1996-07-22
OPUS B12 CONTROLS (K962694)Behring Diagnostics, Inc.1996-07-22
WATERS 474 SCANNING FLOURESCENCE DETECTOR (474) (K962574)Waters Corporation1996-07-22
URITEST - NITRITE IN URINE TEST (K954685)Tcpi, Inc.1996-07-22
ELECSYS PRECICONTROL TSH (K962573)Boehringer Mannheim Corp.1996-07-22
MB/BACT MYCROBACTERIA DETECTION SYSTEM (K954468)Organon Teknika Corp.1996-07-22
CVM TRANSPORT (K955451)Hardy Diagnostics1996-07-22
PORT-A-POLE (K961470)Prins Medical Ind., Inc.1996-07-22
DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL (K962630)Casco Standards1996-07-22
MD TECH BIOPSY SET FOR BONE AND BONE MARROW (K961959)Medical Device Technologies, Inc.1996-07-19
SENTINEL LIPASE LIQUID MODEL 17.401B (K961179)Equal Diagnostics, Inc.1996-07-19
MUMPS IGG TEST (K961204)Zeus Scientific, Inc.1996-07-18
PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING (K962604)Convatec, A Division of E.R. Squibb & Sons1996-07-18
LUBRICATING JELLY, LOW VISCOSITY (K961502)Span-America Medical Systems, Inc.1996-07-18
HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT (K960029)Morax1996-07-17
COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER (K962384)Sierra Laboratories, Inc.1996-07-15
BURLEW INFANT HOOD (K962182)Promedic, Inc.1996-07-15
MARPP PRESSURE MONITORING SYSTEM (K960725)Paradigm Medical, Inc.1996-07-15
COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER (K962413)Sierra Laboratories, Inc.1996-07-15
OSTEOMARK (K961562)Ostex Intl., Inc.1996-07-11
SORBCEL ALGINATE/CMC WOUND DRESSING (K962421)Innovative Technologies , Ltd.1996-07-11
ADVANCED MICRO-OSMOMETER MODEL 3300 (K962056)Advanced Instruments, Inc.1996-07-11
HUMAN GROWTH HORMONE IMMUNOASSAY KIT (K961678)Nichols Institute Diagnostics1996-07-08
CDM (K960392)Bio-Rad1996-07-08
MCCOY CELL CULTURES (K955608)Vai Diagnostics, Inc.1996-07-08
ALLIANCE 2690 SEPARATIONS MODULE (K961557)Waters Corporation1996-07-05
CHEK-STIX U.T.I. SELF-TEST (K960888)Bayer Corp.1996-07-05
LIQUISPEX URINE (MICRO)ALBUMIN CONTROL (K962432)Clinical Controls, Inc.1996-07-05
KARL STORZ TWIN TRANSILLUMINATOR (K962032)KARL STORZ Endoscopy-America, Inc.1996-07-05
OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER (K961274)Olympus America, Inc.1996-07-05
NIKE V8 AND NIKE V12 (K962412)Nike, Inc.1996-07-03
SONY DKR-700 DIGITAL STILL RECORDER (K961680)Sony Medical Systems1996-07-03
IN-THE-EAR (K961827)Qualitone1996-07-03
DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER (K962290)Debusk Technology Corp.1996-07-03
MANAN PROSTATE LOCKING INTRODUCER SET (K961377)Manan Medical Products, Inc.1996-07-03
RADIOGRAPHIC GRID (K962338)Unidex Group, Inc.1996-07-03
RIONET HEARING AID HB53-K (K961907)Authorized Hearing Systems, Inc.1996-07-03
MICRO-TOUCH POWDER FREE LATEX SURGICAL GLOVES (K961632)Johnson & Johnson Medical, Inc.1996-07-03
NON-GENERIC (K962310)Classic Elegance Intl., Inc.1996-07-03
MEDCARE TRACHEOSTOMY CARE TRAY (K961167)Medcare Medical Group, Inc.1996-07-02
SUNGLASSES (K962436)Chungsin Kau Optical Mfy. Co. , Ltd.1996-07-02
FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS (K953672)Polymer Technology Intl.1996-07-01
DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE (K961919)Data Medical Associates, Inc.1996-07-01
ACCUMETER H. PYLORI TEST (K960478)Chemtrak, Inc.1996-06-27
COMFIT (K953590)Wembley Rubber Products (M) Sdn Bhd1996-06-27
SINOCHEM NINGBO LATEX EXAMINATION GLOVE, POWDER FREE (K955918)Sinochem Ningbo Imp & Exp Corp.1996-06-27
SUNMAX ENTERPRISE SHANGHAI VINYL POWDERED PATIENT EXAM. GLOVES (K960746)Sunmax Enterprise Shanghai Co. , Ltd.1996-06-27
SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR (K961295)Sil-Med Corp.1996-06-26
EVRON GEL (K961222)Pharmaceutical Innovations, Inc.1996-06-26
COBAS-FP TDM CALIBRATION VERIFICATION TEST SET (K962165)Roche Diagnostic Systems, Inc.1996-06-26
SERIES XE 140XE,40XE,10XE/SERIES SE 140SE,40SE,10SE/SERIES 10TE (K961494)Micro-Mega Societe Anonyme1996-06-26
VITROS SPECIALTY DILUENT (K962235)Johnson & Johnson Clinical Diagnostics, Inc.1996-06-26
BIODATA TESTOSTERONE MAIA KIT (K955102)Biochem Immunosystems (U.S.), Inc.1996-06-24
MAGNETO EYEWEAR (K962169)Nike, Inc.1996-06-24
HANDSAFE (K960386)Handsafe Products Sdn. Bhd.1996-06-21
UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE (K954514)Sciteck Diagnostics, Inc.1996-06-21
ACS LH2 IMMUNOASSAY (K962041)Ciba Corning Diagnostics Corp.1996-06-21
IMPACT (K961694)Matrix Technologies Corp.1996-06-21
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