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

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RecordFirmDate
MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT (K071934)Biomet Manufacturing Corp2007-10-11
CHLORINATED POWDER FREE NITRILE LATEX EXAMINATION GLOVES (K071740)Medtexx Manufacturing Sdn. Bhd.2007-10-04
MODIFICATION TO BIOSTAR OIA SHIGATOX (K071799)Iverness Medical Professional Diagnostics2007-10-02
RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A (K071845)Acclarent, Inc.2007-09-28
DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT (K063675)Diagnostic Hybrids, Inc.2007-09-24
MARROWMINER (K071732)Stemcor Systems, Inc.2007-09-24
TILITE AERO X (K072311)Tisport, LLC2007-09-21
FIXAFLOSS (K071615)Sybron Dental Specialties, Inc.2007-09-21
ALWAYS MENSTRUAL PADS (K071827)Procter & Gamble, Inc.2007-09-20
BACTRACK LCD ALCOHOL DETECTOR (K071067)Khn Solutions, LLC2007-09-14
POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR COATED WITH ALLOGEL (K071170)Smart Glove Corp. Sdn Bhd2007-09-14
VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601 (K072246)Maine Standards Co.2007-09-14
STATIS DENTAL HANDPIECES (K071891)Scican , Ltd.2007-09-13
BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEMENT (K071465)Molnlycke Health Care Us, LLC2007-09-11
BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENT (K071700)Molnlycke Health Care Us, LLC2007-09-11
DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H (K071980)Dade Behring, Inc.2007-09-11
BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT (K071565)Molnlycke Health Care Us, LLC2007-09-10
QUICKIE QX MANUAL FOLDING WHEELCHAIR (K072153)Sunrise Medical, Inc.2007-09-10
BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K071414)Molnlycke Health Care Us, LLC2007-09-10
I-SURGE (K071965)Satelec2007-09-10
NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK) (K071910)Hartalega Sdn Bhd2007-09-06
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K072085)Zibo Hongye Shangqin Plastic Rubbert Co, Ltd.2007-09-04
DENTAL MATRIX BAND (K071858)Fly Cast Technologies, Inc.2007-08-31
SHANGHAI CHINA STAR CORP. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE (K071072)Shanghai China Star Corp2007-08-30
TPC ADVANCECAM INTRA ORAL CAMERA SYSTEM, MODEL AIC 888 (K071485)Tpc Advanced Technology, Inc.2007-08-28
POWDERED VINYL PATIENT EXAMINATION GLOVES (K071686)Langfang Huilong Plastic Product Co., Ltd.2007-08-22
EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS (K071648)Canterbury Scientific , Ltd.2007-08-22
ROOT ZX II (K071190)J. Morita USA, Inc.2007-08-17
REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES (K070036)Ascent Healthcare Solutions2007-08-17
REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES (K070034)Ascent Healthcare Solutions2007-08-17
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) (K072001)Tangshan Hongyun Plastic Products Co., Ltd.2007-08-15
BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS) (K071710)Johnson & Johnson Consumer Products, Inc.2007-08-14
MASTER GUARD NITRILE BLUE POWDERED EXAMINATION GLOVES (K071207)High Momentum Sdn Bhd2007-08-07
DASH (K071775)Ezsurgical2007-08-07
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K071685)Langfang Huilong Plastic Product Co., Ltd.2007-08-06
TRUEFIELD ANALYZER (K063310)Seeing Machines Limited2007-08-02
HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM (K071269)Smiths Medical Asd, Inc.2007-08-01
COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE (K070062)Diesse Diagnostica Senese S.P.A.2007-07-30
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR (K071123)Xuzhou Full Sun Medical Products , Ltd.2007-07-30
ACON U120 URINE ANALYZER, MODEL U111-101 (K070929)ACON Laboratories, Inc.2007-07-30
MASTER GUARD NITRILE BLUE POWDER FREE EXAMINATION GLOVES (K071208)High Momentum Sdn Bhd2007-07-30
ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY (K071587)Inverness Medical Innovations, Inc.2007-07-30
MECHANICAL WHEELCHAIR - L-FRAME SERIES (K071444)Colours 'N Motion2007-07-27
MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVES (K063757)Shanghai Motex Healthcare Co., Ltd.2007-07-27
NON-STERILE, LATEX POWDER FREE PATIENT EXAMINATION GLOVES (MULTICOLORED WITH XYLITOL AND CALCIUM CARBONATE) (K071060)Sgmp Co., Ltd.2007-07-26
MASTER GUARD LATEX POWDER FREE EXAMINATION GLOVES (K071209)High Momentum Sdn Bhd2007-07-25
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE, WHITE) (K071119)Gx Corporation Sdn Bhd2007-07-24
POWDER FREE LATEX EXAMINATION GLOVES (K071322)Quality Gallant Sdn. Bhd.2007-07-13
VINYL CO-POLYMER POWDER FREE EXAMINATION GLOVES, BLUE COLOR (K070852)Shijiazhang Hongxiang Plastic Products Co., Ltd.2007-07-13
BENVENUE VCF OSTEO COIL SYSTEM (K070293)Benvenue Medical, Inc.2007-07-10
POWDER-FREE VINYL EXAMINATION GLOVES (K071022)Glormed Colombia S.A.2007-07-05
A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT (K070663)A-Dec, Inc.2007-07-05
LIQUICHEK TUMOR MARKER CONTROL (K071675)Bio-Rad Laboratories2007-07-03
SILHOUETTE, MODEL 1000.01 (K070426)Aranz Medical Limited2007-06-29
CERADRILL (K071352)Gebr. Brasseler GmbH & Co. KG2007-06-29
SMS GLUCOSE CONTROL, MODEL 2120059 (K071433)Specialty Medical Supplies2007-06-28
POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING (K070619)Wrp Asia Pacific Sdn. Bhd.2007-06-27
TRIFLEX SELECT (K070647)Cardinal Health, Inc.2007-06-22
POWDERED LATEX EXAMINATION GLOVES (K071323)Quality Gallant Sdn. Bhd.2007-06-22
GENESISCS COMPONENT CONCENTRATING SYSTEM (K070666)Perfusion Partners & Assoc., Inc.2007-06-20
KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5 (K071195)Ani-Kal Ii, LLC2007-06-20
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING (K070639)Siam Sempermed Corp., Ltd.2007-06-15
PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422 (K070869)Dentalez, Inc.2007-06-15
POWDER FREE CHLORINATED LATEX PATIENT EXAMINATION GLOVE (K070760)Derma Care Plus Products, LLC2007-06-07
MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002 (K071140)Top Spins, Inc.2007-06-07
LUBRINA, MODEL HIM-1 (K070074)J. Morita USA, Inc.2007-05-31
POWDER FREE NITRILE EXAMINATION GLOVES (BLUE, WIHTE) (K070862)Purtech Cleanroom Products Co., Ltd.2007-05-30
SMARTSPONGE SYSTEM (K071355)Clearcount Medical Solutions, Inc.2007-05-24
SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFAB (K070457)Sun Scientific, LLC2007-05-16
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (K070861)Hong Xin Rubber Products Co., Ltd.2007-05-15
POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE (K070821)Medtexx Manufacturing Sdn. Bhd.2007-05-10
LENSTEC LC INJECTION SYSTEM (K063802)Lenstec, Inc.2007-05-07
CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3 (K070741)Cliniqa Corporation2007-05-04
PRODERMA LIQUID BANDAGE (K063202)Procurement Technology Systems, LLC2007-05-02
VIEWMATE SYSTEM (K071028)Ep Medsystems2007-05-01
ZIMMER CUT RESISTANT GLOVE LINER, XSMALL, SMALL, MEDIUM, LARGE, XLARGE (K063582)Zimmer, Inc.2007-04-26
LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X (K070848)Bio-Rad, Diagnostics Grp.2007-04-25
QUICK VUE RSV TEST, MODELS 20193, 20199 (K070747)Quidel Corp.2007-04-23
EXICLIP EXCS-M (K070836)Clevex, Inc.2007-04-20
TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP (K061756)Shen Wei (Usa), Inc.2007-04-19
SMS MULTI GLUCOSE CONTROL, MODEL 2120049 (K070506)Medical Specialties Supply Co., Inc.2007-04-18
SPI VECTODRILL CERAMIC DRILLS (K070290)Thommen Medical AG2007-04-17
LINDE INTEGRATED VALVE (LIV) (K063354)Linde Gas Therapeutics2007-04-17
MEISINGER BENEX, MODEL BE001 (K062130)Hager& Meisinger GmbH2007-04-16
AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY (K070174)Roche Diagnostics Corporation2007-04-16
BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE (K062526)Multisafe Sdn. Bhd.2007-04-13
SMS GLUCOSE CONTROL, MODEL 2120061 (K070649)Spectrum Medical Supply, Inc.2007-04-12
GC MI PASTE PLUS (K070854)GC America, Inc.2007-04-12
AMMONIA/ALCOHOL CONTROL SET (K070504)Pointe Scientific, Inc.,2007-04-11
POWDERED LATEX SURGICAL GLOVE (K062797)Beijing Reagent Latex Products Co., Ltd.2007-04-11
PRIME PROTECTION POWDERED VINYL EXAMINATION GLOVES (K070519)Zhang Jia Gang Huayuan Plastic Co. , Ltd.2007-04-10
RMI LCD ALCOHOL DETECTOR (K062545)Resource Management International, LLC2007-04-09
POWERED NITRILE BLUE EXAMINATION GLOVES (K061505)Liwe Trading2007-04-09
OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 (K062862)Olympus America, Inc.2007-04-06
FASTPACK TOTAL PSA METHOD VERIFICATION KIT (K062957)Qualigen, Inc.2007-04-02
PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02 (K070127)Kevin Vu, Dds2007-03-29
POWDERED FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES (K070041)Shijiazhuang Lianhe Shunda Plastic Products Co., L2007-03-28
APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS (K061377)Pointe Scientific, Inc.,2007-03-28
MONARCH III IOL DELIVERY SYSTEM (K063155)Alcon Manufacturing, Ltd.2007-03-27
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES (K070404)Tangshan Luxiong Plastic Products Co., Ltd.2007-03-26
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Every clearance here is in the API, with alerts when new ones post.