Atlas FDA

2006

3,217 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MRGFUS GENERAL PURPOSE AND BREAST COIL (K061715)Insightec Txsonics, Inc.2006-07-28
IBA PROTON THERAPY SYSTEM - PROTEUS 235 (K061913)Ion Beam Applications S.A.2006-07-28
BIOPSY MEDIUM, MODEL REF 1062 (K060983)Medicult A/S2006-07-28
DIAGNOSOFT HARP (K061368)Diagnosoft, Inc.2006-07-28
ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000 (K060354)Acro Biotech, LLC2006-07-28
FEMECC ENDOCERVICAL CURETTE (K060320)Femspec LLC2006-07-28
PRIMA ANAESTHESIA MACHINE (K061102)Penlon , Ltd.2006-07-28
CALYPSO 4D LOCALIZATION SYSTEM (K060906)Calypso Medical Technologies, Inc.2006-07-28
ECLIPSE WAX REMOVER (K061580)Dentsply International2006-07-28
INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER ACCESSORY (K061930)Fonar Corp.2006-07-28
ACTIVE RENIN IRMA (K061758)Diagnostic Systems Laboratories, Inc.2006-07-28
NEWPORT E500 WAVE VENTILATOR (K061094)Newport Medical Instruments, Inc.2006-07-28
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO (K061643)Shimadzu Medical Systems2006-07-27
IMPLANTIUM PROSTHETICS (K052957)Dentium Co., Ltd.2006-07-27
MASIMO SET RADICAL 7 PULSE CO-OXIMETER (K061204)Masimo Corporation2006-07-27
FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05 (K061865)Guidant Corp.2006-07-27
SYNTHES (USA) 6.5 MM CANCELLOUS SCREWS (K061621)Synthes (Usa)2006-07-27
URGOTUL AG (K061220)Laboratoires Urgo2006-07-27
KSEA ROTOCUT G1 ELECTROMECHANICAL MORCELLATOR (K061180)KARL STORZ Endoscopy-America, Inc.2006-07-27
XIA TITANIUM SPINAL SYSTEM AND XIA STAINLESS STEEL SPINAL SYSTEM (K061854)Stryker Spine2006-07-27
SYNGO MULTIMODALITY WORKPLACE (K061964)Siemens AG Medical Solutions2006-07-27
TOPSLANE DMLC (K060187)Topslane International, LLC2006-07-27
M2A MAGNUM 12/14 TAPER INSERTS AND ONE-PIECE MODULAR HEADS (K061423)Biomet Manufacturing Corp2006-07-27
INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM (K061640)Integra LifeSciences Corporation2006-07-27
FLEXO DENTAL RESIN MATERIAL (K061501)Aci, Inc.2006-07-26
ALTES BUTTRESS PLATING SYSTEM (K061482)Altiva Corp.2006-07-26
TSO3 OZONE STERILIZER, MODEL 125L (K051595)Tso3, Inc.2006-07-26
IFS CANNULATED BONE SCREW (K061620)Internal Fixation Systems, Inc.2006-07-26
PIN SCREW (K061599)Bk Meditech, Co., Ltd.2006-07-26
TRULENE MESH (K060018)Sutures India Pvt., Ltd.2006-07-26
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1 (K061476)Biomedical Life Systems, Inc.2006-07-26
BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020 (K061162)Applied Spine Technologies, Inc.2006-07-26
FSSB NYLON SURGICAL SUTURES (K060471)Fssb Chirurgische Nadeln GmbH2006-07-26
VYCOR SURGICAL ACCESS SYSTEMS (K060973)Vycor Medical, LLC2006-07-26
INSORB ABSORBABLE STAPLE, MODEL 1020 (K061784)Incisive Surgical, Inc.2006-07-26
SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS (K061285)Cardinal Health, Alaris Products2006-07-26
HITCH LACTOSORB SUTURE ANCHOR (K061657)Arthrotek, Inc.2006-07-25
INTEGRA RADIONICS XKNIFE RT 4 (K061893)Integra Radionics, Inc.2006-07-25
BRAINPRO, BRAINPRO ACCESS (K060808)PAJUNK GmbH Medizintechnologie2006-07-25
APNEALINK, MODEL 22302 (K061405)Resmed Germany, Inc.2006-07-25
ORAL BALANCE LIQUID/ GEL (K061331)Laclede, Inc.2006-07-25
SYNGO EXPERT-1 (K061449)Siemens Medical Solution2006-07-25
ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO (K061637)Shimadzu Medical Systems2006-07-25
ERAD PACS (K061421)Erad, Inc.2006-07-25
VARISOURCE 200 HDR AFTERLOADER (K061582)Varian Medical Systems, Inc.2006-07-25
ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT (K061665)Arthrex, Inc.2006-07-25
PULSION PICCO PLUS, MODEL 8100 (K060898)Pulsion Medical Systems AG2006-07-25
HYDROMARK BIOPSY SITE MARKER (K060769)Biopsy Sciences, LLC2006-07-25
21.3 INCH MONOCHROME LCD MONITOR (K061947)Nec Display Solutions , Ltd.2006-07-25
POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED (BLUE AND WHITE) (K061724)Smart Glove Corp. Sdn Bhd2006-07-25
EBI 5.5 HELICAL FLANGE SPINAL SYSTEM (K061441)Ebi, L.P.2006-07-25
SURGI-CUF REUSABLE, RS SERIES (K061962)Ethox International2006-07-25
FITPACK (K060037)Asp Plastics Pty , Ltd.2006-07-25
ELEMENT BLOOD GLUCOSE TEST SYSTEM (K060793)Home Diagnostics, Inc.2006-07-25
DYNAMIC MRI SOFTWARE OPTION FOR C-SCAN, E-SCAN XQ AND E-SCAN OPERA (K061429)Esaote, S.p.A.2006-07-25
CD HORIZON SPINAL SYSTEM (K061915)Medtronic Sofamor Danek2006-07-25
XPERT, GENEXPERT DX SYSTEM (K060540)Cepheid2006-07-25
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088 (K053446)Gen-Probe, Inc.2006-07-25
INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NBUP URINE TEST (K060527)Alfa Scientific Designs, Inc.2006-07-25
MERITS HEALTH PRODUCTS PORTABLE NEBULIZER (K053490)Merits Health Products Co., Ltd.2006-07-24
PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER) (K061151)Pioneer Surgical Technology2006-07-24
VERSYS FIBER METAL MIDCOAT LOW HEAD CENTER HIP PROSTHESIS (K061786)Zimmer, Inc.2006-07-24
OR SPECIFIC BIG CASE BACK TABLE COVER (K052668)Or Specific, Inc.2006-07-24
UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM (K061229)Blackstone Medical, Inc.2006-07-24
VERESURE BELL (K061387)Veresure, Inc.2006-07-21
MP RAPIDOXY TEST STRIP, MODEL 07RD-7073 (K051958)Mp Biomedicals, LLC2006-07-21
MD-TEMP (K061530)Meta Biomed Co., Ltd.2006-07-21
PREFORMANCE POSTS AND TEMPORARY CYLINDERS (K061969)Implant Innovations, Inc.2006-07-21
GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (K060205)Horiba Abx2006-07-21
VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001 (K061743)Maquet Cardiopulmonary, AG2006-07-21
DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A (K060619)Diazyme Laboratories2006-07-21
MAGIS1;MAGIS2 (K061713)Direx Systems Corp.2006-07-21
TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM (K061683)Roche Diagnostics Corp.2006-07-21
DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS (K060489)Dade Behring, Inc.2006-07-21
PELEX-04 WIRELESS ELECTROCARDIOGRAPH WITH SOFTWARE ACCESSORIES (K061977)Pinmed, Inc.2006-07-21
COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 (K061574)Beckman Coulter, Inc.2006-07-21
ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE (K061823)Voco GmbH2006-07-21
QUANTIVA (K061418)Tomographix IP , Ltd.2006-07-21
MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307 (K060739)Khrunichev State Research & Production Space Centr2006-07-21
AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020 (K061556)Amedica Biotech, Inc.2006-07-21
NOMOSSTAT, VERSION 1.0 (K060895)Nomos Corp.2006-07-21
QMS TOBRAMYCIN (K060998)Seradyn, Inc.2006-07-21
5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2116A (ME551I2) (K061447)Totoku Electric Co., Ltd.2006-07-21
I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP) (K053597)I-Stat Corporation2006-07-21
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS (K061687)Dade Behring, Inc.2006-07-21
ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM (K061946)Siemens Medical Solutions USA, Inc.2006-07-21
VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS (K061588)Ortho-Clinical Diagnostics, Inc.2006-07-21
AEQUALIS REVERSED PROSTHESIS (K061439)Tornier2006-07-20
REVERE STABILIZATION SYSTEM (K061202)Globus Medical, Inc.2006-07-20
EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3 (K061376)Theratest Laboratories, Inc.2006-07-20
DEL SOL BLUE LIGHT THERAPY SYSTEM (K061470)Edge Systems Corporation2006-07-20
RANDOX LIQUID PROTEIN CALIBRATOR (K061056)Randox Laboratories, Ltd.2006-07-20
PRESTIGE CPAP FLOW GENERATOR WITH PRESTIGE HUMIDIFIER (K061200)Resmed, Ltd.2006-07-20
M-COR HIP REPLACEMENT SYSTEM (K053417)Portland Orthopaedics Pty. , Ltd.2006-07-20
TCS UNBREAKABLE (K053060)Thermoplastic Comfort Systems, Inc.2006-07-20
ALLTHREAD LACTOSORB SUTURE ANCHOR (K061389)Arthrotek, Inc.2006-07-19
OPTILENE MESH (K061704)Aesculap, Inc.2006-07-19
QUIKCLOT 1ST RESPONSE & QUIKCLOT ACS+ (K061767)Z-Medica Corporation2006-07-19
MEDLINE SYRINGES, MULTIPLE (K061275)Medline Industries, Inc.2006-07-19
TROKAMED GMBH ENDOSCOPES AND ACCESSORIES (K060233)Trokamed GmbH2006-07-19
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