Atlas FDA

2003

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

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RecordFirmDate
5MP TFT LCD MONITOR SYSTEM IF2105A BY WIDE CORPORATION (K031929)Wide Corporation2003-07-08
INTRAOS 70 (K031118)Blue X Imaging Srl2003-07-08
NGT (K022558)Medical Innovative Products2003-07-08
SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM (K031555)Synthes (Usa)2003-07-08
WEST NILE VIRUS IGM CAPTURE ELISA (DEN030004)Panbio Limited2003-07-08
TERUMO SURGUARD 2 SAFETY NEEDLE (K031453)Terumo Medical Corp.2003-07-08
SEZ SAFETY SYRINGE (K031163)Sez Corporation2003-07-08
PROFESSIONAL BLOOD SAMPLE RETRIEVAL SYSTEM (K030076)Biomed Personal Metabolic and Nutritional Testing2003-07-07
MODEL 780 (K031383)Hudson Respiratory Care, Inc.2003-07-07
REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001 (K031208)Corgenix, Inc.2003-07-07
ITI DENTAL IMPLANT SYSTEM (K031055)Straumann USA2003-07-07
FOTONA FIDELIS PLUS ND:YAG LASER SYSTEM (K024204)Fotona D.D.2003-07-07
NXSTAGE SYSTEM ONE (K030470)Nxstage Medical, Inc.2003-07-07
DIGITAL CLINICAL THERMOMETER, MODELS ACT2130, ACT 2230, ACT 2330, ACT 3136, AND ACT 3030 (K031905)Actherm, Inc.2003-07-07
VENTLAB BACTERIAL FILTER, MODEL BF100 (K030271)Ventlab Corp.2003-07-07
MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K031777)Cordis Corp.2003-07-07
RESPIRATORY HUMIDIFIER, MODEL MR850 (K020332)Fisher & Paykel Healthcare, Ltd.2003-07-07
FASTPACK FREE T4 IMMUNOASSAY (K030329)Qualigen, Inc.2003-07-03
PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS 860286, 860287, 860288, 860289, 860290, 860291 (K031422)Philips Medical Systems2003-07-03
GENERAL SEMEN ANALYSIS (GSA) KIT (K024337)Bioshaf , Ltd.2003-07-03
CARBON FIBER BRIDGE, MODEL 28757 (K031070)Nobel Biocare AB2003-07-03
SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES (K030919)Medisiss2003-07-03
SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING THE ENSEAL CONTROLLER ADAPTER, ENSEAL OPEN AND LAPAROSCOPIS (K031133)Surgrx, Inc.2003-07-03
SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION (K031193)Alcon, Inc.2003-07-03
STAND OUT (K031484)Kerr Corp.2003-07-03
EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY SYSTEM (K024303)Edwards Lifesciences, LLC2003-07-03
MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM (K031843)Medline Industries, Inc.2003-07-03
ACCU-CHEK COMPACT TEST STRIP (K031755)Roche Diagnostics Corp.2003-07-03
MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES (K031623)Coalescent Surgical2003-07-03
PERSONAL DIGITAL WORKSTATION (PDW); FILM DIGITIZING CAMERA AND DIGITAL WORKSTATION (K031372)Maxxvision, LLC2003-07-02
SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING (K031790)Vision-Sciences, Inc.2003-07-02
RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE (K031688)Guidant Corporation2003-07-02
FILL-IN (K031476)Sybron Dental Specialties, Inc.2003-07-02
READI-STRAND, MODEL PSSTRAND (K023179)Worldwide Medical Technologies, LLC2003-07-02
DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM (K024307)Sybaritic, Inc.2003-07-02
MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23 (K030113)Branan Medical Corp.2003-07-02
SYNTHES ANTERIOR CERVICAL LOCKING PLATE (ACLP) SYSTEM (K031276)Synthes (Usa)2003-07-02
ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX (K031827)Medtronic Perfusion Systems2003-07-02
ESTHETIC ZIRCONIA ABUTMENT (K031719)Nobel Biocare AB2003-07-02
S7 ELITE AND AUTOSET SPIRIT CPAP SYSTEMS WITH RESLINK (K024191)Resmed, Ltd.2003-07-02
C-REACTIVE PROTEIN (CRP) (K030899)Abbott Laboratories2003-07-02
SECQUIRE CELL SEPARATOR (K024080)Perfusion Partners & Assoc., Inc.2003-07-02
MICROHEATER (K031478)Belmont Instrument Corp.2003-07-02
GE DELTA SOFTWARE OPTION FOR MRI (K031927)GE Medical Systems2003-07-02
LIFEVALVE CENTRAL VENOUS CATHTER (K031718)Horizon Medical Products, Inc.2003-07-02
SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS (K031807)Synthes (Usa)2003-07-02
OPTIBOND FL (K031444)Kerr Dental Materials Center2003-07-02
SPI DENTAL IMPLANT ABUTMENTS (K031747)Thommen Medical AG2003-07-02
GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS (K031734)Biomet, Inc.2003-07-01
TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318 (K031685)Smith & Nephew, Inc.2003-07-01
SAFE-CONNECT DRUG DISPENSING SPIKE, MODELS SC 4020, SC 4015, SC 4010, SC 4005 (K031783)Intravascular Incorporated2003-07-01
JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT), PLANECTA LOCK & PLANECTA ADAPTOR (K023668)Jms North America Corp.2003-07-01
URICHEMTRAK LIQUID ASSAYED URINE CONTROL (K031441)Medical Analysis Systems, Inc.2003-07-01
MAINLINE MAXIE HCG URINE PREGNANCY TEST (K031445)Mainline Technology, Inc.2003-07-01
MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL (K031392)Medical Analysis Systems, Inc.2003-07-01
HL168R (K031695)Health & Life Co., Ltd.2003-07-01
MACROPORE OS RECONSTRUCTION (K024169)Macropore Biosurgery, Inc.2003-07-01
HL888RA (K031835)Health & Life Co., Ltd.2003-07-01
DEPUY CERAMIC FEMORAL HEADS (K031803)DePuy Orthopaedics, Inc.2003-07-01
GIVEN DIAGNOSTIC SYSTEM (K031033)Given Imaging , Ltd.2003-07-01
FLEXISKIN POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE (K031754)Pt. Mandiri Inti Buana2003-06-30
ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE (K031141)Asap Endoscopic Products GmbH2003-06-30
ANTIMICROBIAL ALGINATE DRESSING (K024298)Advanced Medical Solutions, Ltd.2003-06-30
SONOVIEW PRO BY MEDISON CO., LTD. (K031886)Medison Co., Ltd.2003-06-30
CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000 (K024323)Biomedical Systems Corp.2003-06-30
INTERFERENTIAL STIMULATOR, MODEL NETWAVE (K031884)Ryan Telemedicine2003-06-30
RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM (K030559)Rusch Intl.2003-06-30
MODIFICATION TO HERMES O.R. CONTROL CENTER (K031382)Computer Motion, Inc.2003-06-30
APEX ELECTRIC HANDPIECE SYSTEM (K031540)Lares Research, Inc.2003-06-30
SOLO-CARE PLUS MULTIPURPOSE SOLUTION (K031522)Ciba Vision Corporation2003-06-27
HI-FLO THERME PNEU 45, WISAP #7083, 7083V (K031014)Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh2003-06-27
YA MEI FIRST AID KIT (K031130)Ya Mei Technology Co., Ltd.2003-06-27
CALCIUM HYDROXYLAPATITE IMPLANT, ICC AND 0.5CC, MODELS 8038-3, 8037-3 (K030682)Bioform, Inc.2003-06-27
EBI P148 SPINAL FIXATION SYSTEM (K031423)Ebi, L.P.2003-06-27
ETI BIPOLAR HEMOSTATIC PROBE (K031026)Endo-Therapeutics, Inc.2003-06-27
PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10 (K031023)Peregrine Surgical , Ltd.2003-06-27
ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT (K031538)Boston Scientific Corp2003-06-27
ORTHOMEND (K031188)Tei Biosciences, Inc.2003-06-27
RAPID IMF (K030605)Zygomatics , Ltd.2003-06-27
U&I, OPTIMA, SPINAL SYSTEM (K031585)U&I Corp., America2003-06-27
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K031888)Medtronic Sofamor Danek2003-06-27
BLACKSTONE SURGICAL TITANIUM MESH (K030744)Blackstone Medical, Inc.2003-06-27
BLASTFREEZE AND BLASTTHAW (K031486)Medicult A/S2003-06-27
EBV VCA-P18 IGG ELISA (K030863)Panbio Limited2003-06-27
SMISSON STABILIZATION SYSTEM (K021979)Smisson-Cartledge2003-06-27
WARTNER PRO (K030838)Wartner Medical Products2003-06-27
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION (K031521)Ciba Vision Corporation2003-06-27
SUSTAIN SPACER (K031302)Globus Medical, Inc.2003-06-27
CD HORIZON SPINAL SYSTEM (K031655)Medtronic Sofamor Danek USA, Inc.2003-06-27
ORIA CLARIS (K023378)Ortho Tec, LLC2003-06-27
K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C (K030687)Kamiya Biomedical Co.2003-06-27
SMART BAG MO (K021328)O-Two Systems International, Inc.2003-06-26
METRICATH SYSTEM COMPRISED OF METRICATH 1000 CONSOLE & METRICATH BALLOON CATHETER (K024000)Angiometrx, Inc.2003-06-26
RAPIDFIRE SELF DRILLING SCREWS (K031751)Walter Lorenz Surgical, Inc.2003-06-26
PRIZM MEDICAL, INC. MICRO-Z STIMULATION SYSTEM (K024181)Prizm Medical, Inc.2003-06-26
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER (K031766)Cook, Inc.2003-06-26
WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS (K031622)Portex , Ltd.2003-06-26
TS3 TUBING SET (K031151)Global Blood Resources, LLC2003-06-26
OSMONICS SOLUTION DELIVERY SYSTEM (K023011)Osmonics Medical Systems2003-06-26
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE) (K031027)Datex-Ohmeda, Inc.2003-06-26
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