Atlas FDA

2003

3,516 FDA 510(k) clearances · Clearance year

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RecordFirmDate
NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN (K030859)Enamelite, LLC2003-03-27
OTI SCAN WITH TRANSDUCERS (K030770)Ophthalmic Technologies, Inc.2003-03-27
FLU OIA A/B TEST KIT (K023556)Thermo Biostar, Inc.2003-03-27
AMSCO CENTURY STEAM STERILIZER (K030789)STERIS Corporation2003-03-26
FIBERFILL SGP (K023819)Pentron Clinical Technologies2003-03-26
LOGOS JUNIOR DENTAL CHAIR AND UNIT (K023513)Castellini S.P.A.2003-03-26
SPI ELEMENT DENTAL IMPLANT O 3.5 MM (K030689)Thommen Medical AG2003-03-26
CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL (K030705)Cliniqa Corporation2003-03-26
CLEARFIL SILANE KIT (K024356)Kuraray Medical, Inc.2003-03-26
GLOVETEX LATEX EXAMINATION GLOVES, POWDERED, BLUE, NON STERILE (K030273)Pt. Wrp Buana Multicorpora2003-03-26
MODIFICATION TO EXPORT ASPIRATION CATHETER (K030201)Medtronic Vascular2003-03-26
PORTA IMPLANT (K030312)Wieland Dental + Technik GmbH & Co. KG2003-03-26
DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEM (K030763)Diagnostic Ultrasound Corp.2003-03-26
BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS (K024240)Bd2003-03-26
MHS 7000 (K030018)Micro Health Systems, Inc.2003-03-26
THERIRIDGE BLOCK, BONE GRAFT SUBSTITUTE (K023998)Therics, Inc.2003-03-26
DENTAL PROTECTOR (K024261)Dental Concepts, LLC2003-03-26
MULTICARE PLATINUM SYSTEM AND ACCESSORIES (K030666)Lorad, A Hologic Co.2003-03-25
BONE WIRE (K030665)Stork Instrumente GmbH2003-03-25
SETPOINT ENDOVASCULAR TEMPERATURE PROBE (K024327)Radiant Medical2003-03-25
LATEX EXAMINATION GLOVES POWDER FREE WITH NEOPRENE LINED, SIZES XSMALL, SMALL, MEDIUM, LARGE, XLARGE (K030134)Pt.Shamrock Manufacturing Corp.2003-03-25
STERILIZATION CASES AND TRAYS (K023658)Carr Metal Products, Inc.2003-03-25
LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9 (K024324)Global Protection Corp.2003-03-25
STANDARD THERMOMETER (K030658)Global Treasure Industries , Ltd.2003-03-25
POWDER FREE NITRILE EXAMINATION GLOVES (NATURAL, BLUE,PURPLE) (K030284)Pt. Smartglove Indonesia2003-03-25
MODEL 1300GE-64: PEDIATRIC POSITIONER (K030317)Midwest Rf, LLC2003-03-25
PROVEN MODULAR TIBIAL TRAY (K030577)Stelkast Company2003-03-25
VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E (K023753)Arista Latindo Industrial Ltd. P.T2003-03-25
20.1 MONOCHROME LCD MONITOR, RADIFORCE G21 (K024358)Eizo Nanao Corporation2003-03-25
VERTE-STACK SPINAL SYSTEM (K030601)Medtronic Sofamor Danek2003-03-25
BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT (K030645)Boston Scientific Corp2003-03-25
LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100 (K020271)Levitronix, LLC2003-03-25
REACTIVE SKIN DECONTAMINATION LOTION (K023969)Dept. of the Army2003-03-25
VINYL EXAMINATION GLOVES, POWDER-FREE WITH VITAMIN E (K023754)Arista Latindo Industrial Ltd. P.T2003-03-25
SYNTHES USS, CLICK'X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USS (K022949)Synthes (Usa)2003-03-24
MODIFICATION TO PLEXOLONG SETS (K023218)Pajunk GmbH2003-03-24
NMA 1052 CONSOLE SYSTEM WITH NMA 100 LASER ACCESSORY (K024310)Medx Electronics, Inc.2003-03-24
AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER (K024349)Aesculap, Inc.2003-03-24
MODIFICATION TO VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTRILLED EXPANSION DELIVERY SYSTEM (K030567)Vascular Architects, Inc.2003-03-24
XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT (K030194)The Olympus Optical Co.2003-03-24
LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCT (K024301)Lsi Solutions2003-03-24
MODIFICATION TO SUZANNE PORTABLE POLYSOMNOGRAPH SYSTEM (K030611)Nellcor Puritan Bennett (Melville) , Ltd.2003-03-24
BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT (K030238)The Binding Site, Ltd.2003-03-24
ACRYLIC (K024282)Inovativ, LLC2003-03-21
AGC CEM (K030168)Wieland Dental + Technik GmbH & Co. KG2003-03-21
SIEMENS INFINITY GATEWAY SUITE, MODEL VF2 (K030657)Siemens Medical Solutions2003-03-21
STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02-POLYPROPYLENE NON-WOVEN DISPOSABLE FI (K030853)Case Medical, Inc.2003-03-21
CHROMOPHARE X 65 (K024132)Berchtold Holding GmbH2003-03-21
POWDERFREE LATEX EXAMINATION GLOVES WITH GRAPE (K030560)Pt.Shamrock Manufacturing Corp.2003-03-21
ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452 (K022198)Richard Wolf Medical Instruments Corp.2003-03-21
POWDER-FREE RADIATION ATTENUATING NEOPRENE SURGICAL GLOVE (BLACK) (K022873)International Biomedical, Inc.2003-03-21
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA (K030397)Hycor Biomedical , Ltd.2003-03-21
100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM (K030107)Boston Scientific Corp2003-03-21
STIMUPLEX-DIG-RC NERVE STIMULATOR (K021033)B.Braun Medical, Inc.2003-03-21
POD PAC-20M (K030610)Portable Ophthalmic Devices, Inc.2003-03-21
INFINITY EXPLORER (K030615)Siemens Medical Solutions USA, Inc.2003-03-21
PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS (K022212)Mentor Medical Limited2003-03-21
LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING CLAIM (K030333)Perusahaan Getah Asas Sdn. Bhd.2003-03-21
ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM (K030331)Perusahaan Getah Asas Sdn. Bhd.2003-03-21
M2376A DEVICELINK SYSTEM (K030731)Philips Medical Systems, Inc.2003-03-21
JI-EE ELECTRIC SCOOTER, ELEGANCE ES 3 (K024329)Ji-Ee Industry Co., Ltd.2003-03-21
MODIFICATION TO SOLAR 9500 INFORMATION MONITOR (K030575)Ge Medical Systems Information Technologies2003-03-21
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (K030114)Vanguard Medical Concepts, Inc.2003-03-21
IQTEQ SPIROMETER (K020102)Iqteq Development2003-03-21
CANDELA GENTLELASE FAMILY OF LASER SYSTEMS (K024260)Candela Corp.2003-03-21
CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82) (K030590)Hitachi Chemical Diagnostics, Inc.2003-03-21
BPTRU VITAL SIGNS MONITOR, MODEL BPM-300, & BPTRU PORTABLE AUTOMATED NON-INVASIVE BLOOD PRESSURE AND TEMPERATURE MONITOR (K023078)Vsm Medtech , Ltd.2003-03-21
FIXOBRIDGE 3-CEMENT (K024287)Advanced Healthcare , Ltd.2003-03-21
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NALIDIXIC ACID - 2-32 UG/ML (K030579)Becton, Dickinson & CO2003-03-21
CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL (K030768)Cliniqa Corporation2003-03-21
CROSSEAL APPLICATION DEVICE (K030032)Omrix Biopharmaceuticals, Inc.2003-03-21
MODIFICATION TO NASAL-AIRE (K022465)Innomed Technologies2003-03-21
GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER (K023692)Howmedica Osteonics Corp.2003-03-20
ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475 (K024291)Arthrex, Inc.2003-03-20
KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW (K030368)KARL STORZ Endoscopy-America, Inc.2003-03-20
GENICON CLIP APPLIER (K030269)Genicon, LC2003-03-20
OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM (K024012)Ge Oec Medical Systems2003-03-20
MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, AND MMT-359L9 (K030149)Avail Medical Products, Inc.2003-03-20
ORIA ZENITH (K030500)Ortho Tec, LLC2003-03-20
PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH03 (K030411)Ethicon Endo-Surgery, Inc.2003-03-20
POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE (K030200)Kaohsiung Brothers Products Corp.2003-03-20
SYNTHES 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES (K030597)Synthes (Usa)2003-03-20
STRYKER BIOZIP SUTURE ANCHOR (K023192)Stryker Endoscopy2003-03-20
VISTA BASIC WITH FM SYSTEM (K023189)B.Braun Medical, Inc.2003-03-20
EVA DIGITAL DENTAL X-RAY SYSTEM (K030647)Afp Imaging Corp.2003-03-20
ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH (K022947)Terumo Cardiovascular Systems Corp.2003-03-20
EBI DYNAFIX COMPRESSION BONE SCREW (K030706)Ebi, L.P.2003-03-20
DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B (K030537)Well-Life Healthcare, Inc.2003-03-20
FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS (K023162)Fresenius Medical Care2003-03-20
AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV (K030698)Aesculap, Inc.2003-03-20
INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3 (K030814)Invacare Corp.2003-03-20
X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS (K030501)Biomet, Inc.2003-03-20
HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME (K023487)OraSure Technologies, Inc.2003-03-20
STRYKER LEIBINGER CRANIAL FIXATION SYSTEM (K030378)Stryker Instruments2003-03-20
CRYOPROBE (K024009)H&O Equipments, Nv/Sa2003-03-20
ENHANCE SPERM FREEZE (K030117)Conception Technology, Inc.2003-03-20
ATAC CALIBRATOR (K030621)Elan Diagnostics2003-03-19
WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553 (K030482)Wiener Laboratories2003-03-19
CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50 (K023990)Precision Biologic2003-03-19
OPTION-VF URINARY CATHETER, FV14218 (K023090)Opticon Medical, Inc.2003-03-19
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Every clearance here is in the API, with alerts when new ones post.