Atlas FDA

2002

3,685 FDA 510(k) clearances · Clearance year

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RecordFirmDate
CERALOY SOLDER (K021968)Neirynck & Vogt NV2002-07-26
ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM (K022164)Zeta Development Laboratories2002-07-26
ILT ADVANCING MECHANISM, MODEL A115AMI (K021638)Intra Luminal Therapeutics, Inc.2002-07-26
XTD THROMBECTOMY CATHETER, XX CM (K021641)Xtrak Medical, Inc.2002-07-26
ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER (K011329)E. Benson Hood Lab, Inc.2002-07-26
SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG (K020882)Surgical Specialties Corp2002-07-26
ELPH INJECTION SYSTEM (K022116)Mallinckrodt Inc., Liebel-Flarsheim Business2002-07-26
AUROPAL 60 (K021926)Wieland Dental + Technik GmbH & Co. KG2002-07-25
CLARREN HELMET (ORTHOMERICA) (K021918)Orthomerica Products, Inc.2002-07-25
STAT PROFILE PHOX PLUS C ANALYZER (K021713)Nova Biomedical Corp.2002-07-25
MODOFOCATION TO SYNTHES ANKLE ARTHRODESIS PLATES (K022255)Synthes (Usa)2002-07-25
NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE (K021336)Novabone Products, LLC2002-07-25
CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLES (K022169)Parallax Medical, Inc.2002-07-25
K-ASSAY LP(A) ASSAY (K021660)Kamiya Biomedical Co.2002-07-25
MULTIGAS UNIT, MODEL AG-920RA (K020046)Nihon Kohden America, Inc.2002-07-25
ORTHOPILOT HTO MODULE (K021327)Aesculap, Inc.2002-07-25
BRIGHT GOLD (K021892)Ivoclar Vivadent, Inc.2002-07-25
EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE (K022119)Electro Medical Systems SA2002-07-25
MAGNETOM TRIO QUADRATURE TX/RX HEAD COIL (K021330)Usa Instruments, Inc.2002-07-25
VECTOR MEDICAL, INC., VECTOR TARGETING SYSTEM (K022225)Vector Medical, Inc.2002-07-25
PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING (K022094)Biomet, Inc.2002-07-25
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K021061)Medtronic Sofamor Danek2002-07-25
THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050 (K022108)Thermo Dma, Inc.2002-07-25
WU'S 3-WHEELED NEO SCOOTER, WT-M3 (K014119)Wu'S Tech Co., Ltd.2002-07-25
TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540 (K021504)Tuttnauer U.S.A Co, Ltd.2002-07-25
36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) (K022077)Howmedica Osteonics Corp.2002-07-25
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MOXIFLOXACIN 0.125-8 UG/ML (K022129)Becton, Dickinson & CO2002-07-25
ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR (K021316)Genzyme Corp.2002-07-25
J&S MEDICAL SENTRY URINE DIPSTICK CONTROL (K022085)J & S Medical Assoc., Inc.2002-07-25
CLINDATALINK VERSION 1.0 FOR SPIROMETRY (K020004)Compleware Corp.2002-07-24
HEARTLINE RECEIVING STATION (K022073)Aerotel Medical Systems (1998) , Ltd.2002-07-24
MODIFICATION TO TOWNLEY TRANSFACEPEDICULAR SCREW FIXATION SYSTEM (K021705)Medtronic Sofamor Danek, Inc.2002-07-24
PRISMAFLO (K020103)Stihler Electronic GmbH2002-07-24
CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT (K021499)DePuy Orthopaedics, Inc.2002-07-24
PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM) (K021784)Wrp Asia Pacific Sdn. Bhd.2002-07-24
CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM (K020828)Bayer Corp.2002-07-24
SYNTHES IN-SITU BENDER/CUTTER (K021458)Synthes (Usa)2002-07-24
ENDOSSOUS IMPLANTS (K021322)Intra-Lock International2002-07-24
MPF ACETABULAR CUP GENERATION 2 (K022120)Plus Orthopedics2002-07-24
ABP FOR WINDOWS (K021517)Rozinn Electronics, Inc.2002-07-24
CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE (K021466)Hayes Medical, Inc.2002-07-24
MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM (K022190)Depuyacromed2002-07-24
DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE (K021376)Datex-Ohmeda2002-07-24
INFINITY MICRO2+ (K012770)Siemens Medical Solutions USA, Inc.2002-07-23
'RAPIDTEC' 5A MULTIPLE DIP TEST (K021114)American Bio Medica Corp.2002-07-23
CRIT-LINE MONITOR III TQA (CLM TQA) (K011741)Hemametrics2002-07-23
RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED (K021764)Rusch Intl.2002-07-23
PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007 (K012974)Prizm Medical, Inc.2002-07-23
MICROPAQ, MODELS 402, 404 (K021681)Welch Allyn Protocol, Inc.2002-07-23
MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95 (K020474)Makrite Industries, Inc.2002-07-23
VENTURE HOMEFILL II WITH OXYGEN CONSERVER (K021685)Invacare Corp.2002-07-23
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200 (K021516)Axis-Shield Diagnostics, Ltd.2002-07-23
PROLITE PULSED LIGHT SYSTEM (K021304)Big Sky Laser Technologies, Inc.2002-07-23
R120 MODULAR TOTAL HIP SYSTEM (K021822)Osteoimplant Technology, Inc.2002-07-23
VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL (K022046)Vital Scientific N.V.2002-07-23
ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM (K020356)Alphatec Mfg., Inc.2002-07-23
INJEX 30 NEEDLE FREE INJECTION SYSTEM (K022148)Equidyne Systems, Inc.2002-07-23
ACCU-CHEK COMPACT SYSTEM (K022171)Roche Diagnostics Corp.2002-07-23
CALIBRATING MATERIAL, BUFFERS, STANDARD (K022027)Mission Diagnostics2002-07-22
SEARCH EVOLUTION TOTAL KNEE SYSTEM (K021313)Aesculap, Inc.2002-07-22
OPUS MAGNUM ANCHOR & INSTRUMENT SET (K020172)Opus Medical, Inc.2002-07-22
ATLANTIS VISION ANTERIOR CERVICAL PLATE SYSTEM (K021461)Medtronic Sofamor Danek2002-07-22
MASTERGRAFT RESORBABLE CERAMIC (K020986)Medtronic Sofamor Danek, Inc.2002-07-22
IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) (K022118)Diagnostic Products Corp.2002-07-22
COLORADO 2 SPINAL SYSTEM (K020247)Medtronic Sofamor Danek, Inc.2002-07-22
XANTUS ANTERIOR LATERAL SUPPLEMENTAL FIXATION SYSTEM (K022070)Medtronic Sofamor Danek, Inc.2002-07-22
VECTORSONIC, MODEL VU-200 (K020119)Metron Medical Australia, Pty, Ltd.2002-07-22
BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET (K021475)Bd2002-07-19
STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM FIXATION SYSTEM (K022033)Bioplate, Inc.2002-07-19
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON SYSTEMS CX C-RP CALIBRATOR (K021572)Beckman Coulter, Inc.2002-07-19
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE02 AND L-ANE02A SOFTWARE (K021279)Datex-Ohmeda2002-07-19
POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HOLES) (K022000)Spire Biomedical, Inc.2002-07-19
ADMIRA PROTECT (K021844)Voco GmbH2002-07-19
LIGHT CURE DENTAL DAM (K021524)Prime Dental Manufacturing, Inc.2002-07-19
SECURE SOFT (K021437)Imtec Corp.2002-07-19
MODIFICATION TO RAICHEM CALCIUM REAGENT (K022049)Hemagen Diagnostics, Inc.2002-07-19
MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS) (K022026)Medtronic Ave, Inc.2002-07-19
KOLIBRI IGS SYSTEMS (K014256)Brainlab AG2002-07-19
SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF (K020910)The Electrode Store, Inc.2002-07-19
CHEMWELL, ALSO KNOWN AS PROJECT 2900 (K013420)Awareness Technology, Inc.2002-07-19
ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE (K011591)Wilson-Cook Medical, Inc.2002-07-19
JAS HDL CHOLESTEROL (AUTOMATED) REAGENT (K021671)Jas Diagnostics, Inc.2002-07-19
QIZHOU ACUPUNCTURE NEEDLE (K013926)Wujiang City Shenli Medical and Health Material CO2002-07-18
VIDAS TESTOSTERONE (TES), MODEL 30 418 (K021326)bioMerieux, Inc.2002-07-18
GALT MEDICAL GUIDEWIRE (K021990)Galt Medical Corp.2002-07-18
REPROCESSED FEMORAL COMPRESSION DEVICE (K012574)Sterilmed, Inc.2002-07-18
STEAMPLUS STERILIZATION TEST (K020409)Spsmedical Supply Corp.2002-07-18
MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE (K021991)Syncro Medical Innovations, Inc.2002-07-18
V-2100G ADVANCED INFANT INCUBATOR (K021809)Atom Medical Corp2002-07-18
MICOMED POSTERIOR DOUBLEROD SYSTEM (K021275)Micomed Ortho GmbH2002-07-18
THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM, MODEL UV120-2 (K022165)Theralight, Inc.2002-07-18
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM (K022015)Medtronic Sofamor Danek, Inc.2002-07-18
BAYER RAPIDPOINT 405 SYSTEM (K020616)Bayer Diagnostics Corp.2002-07-17
ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE (K021526)ACON Laboratories, Inc.2002-07-17
HLS NOETOS SYSTEM (K013906)Tornier2002-07-17
WRIST FUSION PLATE (K021321)Acu Med, Inc.2002-07-17
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX2 (K021967)Implex Corp.2002-07-17
MICROSCAN SYNERGIES PLUS DRIED GRAM NEGATIVE MIC/COMBO PANELS WITH CEFTAZIDIME (1-16 UG/ML) (K020413)Dade Behring, Inc.2002-07-17
SURGERY AND ACCESSORIES (K021236)Camtronics, Ltd.2002-07-17
ALBUMIN REAGENT (K021636)Intersect Systems, Inc.2002-07-17
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