Atlas FDA

2010

2,807 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCH BP HOME N BP3MX1-4 (K100763)Microlife Intellectual Property GmbH2010-08-27
HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M- (K101892)Heine Optotechnik GmbH & Co. KG2010-08-27
FS ALIGNER (K093821)Allesee Orthodontic Appliances2010-08-27
MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229 (K100367)Origio A/S2010-08-27
14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA (K100141)Siemens Medical Solutions USA, Inc.2010-08-27
LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR (K102129)Levitronix, LLC2010-08-27
MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ FOOT CUFFS, MIDWEST REPROCESSING CENTER REPROCESSED ALP SLE (K101330)Midwest Reprocessing Center, LLC2010-08-27
NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH (K101633)Nova Biomedical Corp.2010-08-27
DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE (K101889)Pivotal Health Solutions2010-08-27
SUR-G GLOV AND MAXITEX (K102119)Terang Nusa Sdn Bhd2010-08-27
BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6 (K100622)Belimed Sauter AG2010-08-27
ACCU-CHEK ULTRFLEX INFUSION SET (K101196)Roche Diagnostics Corp.2010-08-27
QUASAR BLUE LIGHT THERAPY SYSTEM (K093963)Silver Bay, LLC2010-08-27
NON-CHLORINATED, POLYMER COATED POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES AND PROTEIN LABELING CLAIM OF (K101645)Latexx Manufacturing Sdn.Bhd.2010-08-26
INBONE II TOTAL ANKLE REPLACEMENT (K100886)Wrightmedicaltechnologyinc2010-08-26
CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503 (K101100)Conmed Linvatec2010-08-26
CELLTRACKS AUTOPREP SYSTEM MODEL:9541 (K100684)Veridex, LLC2010-08-26
JOURNEY CR KNEE SYSTEM (K101499)Smith & Nephew, Inc.2010-08-26
ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E (K101485)Bisco, Inc.2010-08-26
TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T (K100210)Trans1 Incorporated2010-08-26
TENZING SYSTEM (K102130)Mazor Surgical Technologies , Ltd.2010-08-26
SHIMADZU COLLIMATOR R-20J (K101036)Shimadzu Corp.2010-08-26
XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254) (K093420)Luminex Molecular Diagnostics, Inc.2010-08-26
MDPO FRAME SYSTEM (K093753)Mdpo, LLC2010-08-26
STAR/VENT INTERNAL HEX SCREW IMPLANT (K082800)Park Dental Research Corp.2010-08-26
WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES (K093175)Guangzhou Wondfo Biotech Co., Ltd.2010-08-25
ETEST MOXIFLOXACIN 0.002-32 UG/ML (K093604)Ab Biomerieux2010-08-25
TACAMO MANUAL WHEELCHAIR (K101719)Dalton Instrument Corp.2010-08-25
SURGIMAX/ SURGIMAX PLUS (K100390)Elliquence, LLC2010-08-25
FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE (K101728)Cook, Inc.2010-08-25
DUFLO CATHETER (HEPARIN COATED) (K093847)Thermopeutix, Inc.2010-08-25
RAPIDVUE HCG TEST (K102175)Quidel Corporation2010-08-25
LARYNGEAL SURFACE ELECTRODE (K093373)Spes Medica Srl2010-08-24
METAFLEXCOIL (K101632)Neocoil, LLC2010-08-24
MANTIS SPINAL SYSTEM & MANTIS REDUX SPINAL SYSTEM (K102235)Stryker Spine2010-08-24
LEGEND POWER ADAPTER MODEL: 6475000 (K101168)Medtronic Sofamor Danek2010-08-24
ZELTIQ AESTHETICS DERMAL COOLING DEVICE (DEN090002)Zeltiq Aesthetics2010-08-24
ERCHONIA ML SCANNER (MLS) (DEN090008)Erchonia Medical2010-08-24
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K101358)Hebei Handform Plastic Products Co., Ltd.2010-08-24
BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K093954)Bio-Rad Laboratories2010-08-24
CELL-CHEX (K101335)Streck2010-08-23
ACCUFIT DENTAL IMPLANT ABUTMENTS & SCREWS (K101068)Radiant Express, LLC2010-08-23
INNOVIA INNOPORT LAPAROSCOPIC ACCESS PORT (K093783)Innovia, LLC2010-08-23
NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U (K093916)Perkinelmer, Inc.2010-08-23
INNOVATIVE MED MULTI WAVE LIGHT THERAPY SYSTEM (K093204)Innovative Med, Inc.2010-08-23
EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470 (K102082)Boston Scientific Corp2010-08-23
BEAUTIFIL FLOW PLUS (K101603)Shofu Dental Corp.2010-08-23
LITE ART (K101621)Shofu Dental Corp.2010-08-23
LUMENVU CATHETER GUIDANCE SYSTEM (K093510)Sonosite,Inc.2010-08-23
BK BLANK MODEL 20,40,65,90 (K101875)Bk Medent Co., Ltd.2010-08-23
BBL CHROMAGAR MRSA II (K092767)Becton, Dickinson & CO2010-08-20
ZIRCONIA SYRINGE NEEDLE (K093043)Kuo Tai Hospital Managements & Consultant Co., Ltd.2010-08-20
OSIRIX MD (K101342)Pixmeo Sarl2010-08-20
MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3 (K101272)Essex Industries, Inc.2010-08-20
DENTAL HANDPIECES, MODELS: KARAM STD/MINI; BREEZE STD/MINI: KARAM 45; DEXOR 45; KARAM 4H COUPLING (K101717)Aerobine, Inc.2010-08-20
NOBELPROCERA IPS E.MAX CROWN (K100512)Nobel Biocare AB2010-08-20
FLIGHT 60 VENTILATOR, MODEL F-60 (K100753)Flight Medical , Ltd.2010-08-20
INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML) (K101359)Inviro Medical Devices, Inc.2010-08-20
AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015 (K093622)Encision, Inc.2010-08-20
PROCEDURE REHEARSAL STUDIO (K093269)Simbionix , Ltd.2010-08-20
BONEOPTIMIZER (K100841)Curasan AG2010-08-19
GRANDIO FLOW (K101213)Voco GmbH2010-08-19
STN PROBE (K101816)Summit Doppler Systems, Inc.2010-08-19
SYNERGY CT PICC (K101329)Health Line International Corporation2010-08-19
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS (K101789)Sterilmed, Inc.2010-08-19
DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE (K100912)Kirwan Surgical Products, Inc.2010-08-19
SPI VARIOMULTI ANGLED ABUTMENT (K101798)Thommen Medical AG2010-08-19
ADVANCED GLASS IONOMER (K-130) RESTORATIVE (K101493)Dentsply International, Inc.2010-08-19
LAMBERGSLEEPWELL- SMARTRUSION (LSW-S) (K101709)Steven B. Lamberg, Dds2010-08-18
ZIMMER DTO PIN PRESS INSTRUMENT (K101704)Zimmer Spine, Inc.2010-08-18
MODULAR ENDOSCOPE (K093785)Sialo Technology, Ltd.2010-08-18
NEONATE ARRAY COILS (K091047)Lmt Medical Systems GmbH2010-08-18
OSTA MAXIGRO AND REGIGRO (K091424)Osta Technologies2010-08-18
NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURALASE DIODE LASER FAMILY NATURALASE NL810 (K101152)Focus Medical, LLC2010-08-18
HUMAPEN LUXURA HD (K100988)Eli Lilly and Company2010-08-17
CURIEPACS (DICOM PACS SOFTWARE) (K102148)Moksha Digital Software Pvt Limited2010-08-17
POWDER - FREE PATIENT EXAMINATION GLOVES (K101565)Zibio Yingjie Medical Products Co., Ltd.2010-08-17
REPLENS LONG-LASTING VAGINAL MOISTURIZER (35G TUBE WITH REUSABLE APPLICATOR) MODEL: 83035 (K101098)Lil Drug Store Products, Inc.2010-08-17
PRIMAL OK INTERSPINOUS FUSION SYSTEM (K100354)Osteomed LP2010-08-17
STELLARIS PC VISION ENHANCEMENT SYSTEM (K101325)Bausch & Lomb, Inc.2010-08-17
ABREU, MODEL 700 (K100843)Brain Tunnelgenix Technologies Corp2010-08-17
LIGAMENTOTAXOR (K094043)Arex USA2010-08-17
LO-50 LED LIGHT SOURCE (K102167)Fiberoptics Technology, Inc.2010-08-17
NITRIL EXAM GLOVE, PRE-POWERED COLOR WHITE, NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE (K100975)Jiangsu Sunshine Plastic Products, Co., Ltd.2010-08-17
REPLENS LONG-LASTING VAGINAL MOISTURIZER (PRE-FILLED APPLICATOR) (K101241)Lil Drug Store Products, Inc.2010-08-17
DIGITAL RADIOGRAPHY (K102012)Canon Inc. -Medical Equipment Group2010-08-17
HS/HG PROSTHETIC SYSTEM (K100245)Osstem Implant Co., Ltd.2010-08-17
PHARMACARIBE INHALED SALINE SOLUTIONS (K101424)Pharmacaribe2010-08-17
RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER (K101038)Acceletronics Digital Imaging, LLC2010-08-17
ATLANTIS ABUTMENT FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT (K101004)Astra Tech, Inc.2010-08-16
IMC SURGICAL FACE MASK (K100846)International Medsurg Connection2010-08-16
KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH (K101029)Huge Dental Material Co., Ltd.2010-08-16
HUMAN IGA2 KIT FOR USE ON THE SPAPLUS (K100588)The Binding Site Group , Ltd.2010-08-16
SYNGO TRUED SOFTWARE (K101749)Siemens Medical Solutions2010-08-16
LANX FACET SCREW SYSTEM (K101364)Lanx, Inc.2010-08-16
21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL2128A) (K090947)Totoku Electric Co., Ltd.2010-08-16
ASCEND BLUE AC MESH; ASCEND BLUE PC MESH (K101462)Caldera Medical, Inc.2010-08-16
ECHO TD-3227 DUAL BLOOD PRESSURE/BLOOD GLUCOSE METER (K092875)Taidoc Technology Corporation2010-08-13
SPECTRA SERIES BREAST PUMP (K093145)Uzinmedicare Co.2010-08-13
PICC WAND PEELABLE SAFETY INTRODUCER (K101150)Access Scientific, Inc.2010-08-13
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Track 2010 automatically

Every clearance here is in the API, with alerts when new ones post.