Atlas FDA

2003

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

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RecordFirmDate
POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE PROTEIN CONTENT LABE (K031414)Perusahaan Getah Asas Sdn. Bhd.2003-06-26
MINILOK QUICKANCHOR PLUS (K030995)Mitek Worldwide2003-06-26
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND GREEN COLORED (K031591)Perusahaan Getah Asas Sdn. Bhd.2003-06-26
BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION) (K030581)Blackstone Medical, Inc.2003-06-26
SMARTSHAPE BODY COMPOSITION ANALYZER, MODEL 4010 (K023817)Clio Designs, Inc.2003-06-25
IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE (K030035)Diametrics Medical, Inc.2003-06-25
QUANTA PLEX ENA PROFILE 6 (K031450)Inova Diagnostics, Inc.2003-06-25
BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL (K031644)Bayer Healthcare, LLC2003-06-25
EBI XFIX DFS SYSTEM (K031645)Ebi, L.P.2003-06-25
DETECTAR, MODEL N123-MI (K023367)Neks Technologies2003-06-25
RAPIDO CUT-AWAY GUIDING CATHETER (K031505)Guidant Corporation2003-06-25
SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515 (K030708)Bio-Medical Research, Ltd.2003-06-25
LIPOPROTEIN CALIBRATOR (K031682)Bayer Healthcare, LLC2003-06-25
MIRACLE 98 (K031010)Sb Lucius, Inc.2003-06-25
H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM (K014013)H & W Technology, LLC2003-06-25
DATEX-OHMEDA MINI-FILTER/S AND UNI-FILTER JUNIOR (K030990)Datex-Ohmeda2003-06-25
DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIES (K031781)Datex-Ohmeda2003-06-25
CALIBRATING MATERIAL, CALIBRATING STANDARDS (K031159)Diamond Diagnostics, Inc.2003-06-25
ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY (K031756)Roche Diagnostics Corp.2003-06-25
MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE (K031200)Becton, Dickinson & CO2003-06-24
U & I AMERICA SPINAL HOOK SYSTEM (K031595)U&I Corp., America2003-06-24
ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 9923 (K031572)Zimmer, Inc.2003-06-24
MODIFICATION TO COLORADO 2 SPINAL SYSTEM (K030875)Medtronic Sofamor Danek, Inc.2003-06-24
SYNVITRO HYADASE (K031228)Medicult A/S2003-06-24
SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X (K031154)Sintea Biotech, Inc.2003-06-24
SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM (K031725)Synthes (Usa)2003-06-24
NITREX NITINOL GUIDEWIRE (K031864)Ev3 Corporation2003-06-24
SPECTRAPULSE (K031680)Primary Technology, LLC2003-06-24
MODIFICATION TO REMSTAR AUTO CPAP SYSTEM (K031460)Respironics, Inc.2003-06-24
ENDO GATOR SYSTEM (K031773)Byrne Medical, Inc.2003-06-24
BD VIPER INSTRUMENT (K023955)Becton, Dickinson & CO2003-06-24
CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH FLEXIBLE CATHETER MOUNT,CLEAR-GUARD 3 F3 (K024270)Intersurgical, Inc.2003-06-24
BAYER ADVIA CENTAUR CA 19-9 ASSAY (K031393)Bayer Healthcare, LLC2003-06-24
ASYRA (K023355)Galloway Technologies, LLC2003-06-24
ECLIPSE (K030981)Varian Medical Systems, Inc.2003-06-24
BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM (K030578)Computer Motion, Inc.2003-06-24
MODIFICATION TO TRANSPORT INCUBATOR 185 (K031096)International Biomedics, Inc.2003-06-24
UF BRACHYTHERAPY STAND (K023430)University of Florida2003-06-24
ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY (K031038)Bayer Healthcare, LLC2003-06-23
HEMOBAG, MODEL HBBSD2000 (K031150)Global Blood Resources, LLC2003-06-23
VIVATHERM THEMPERATURE MEASUREMENT SYSTEM (K031556)Vivant Medical, Inc.2003-06-23
MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR (K023333)Pleasure Latex Products Sdn. Bhd.2003-06-23
PER, MODEL MEMO (K030218)Medical Monitors Pty., Ltd.2003-06-23
EMBRYOGLUE (K031015)Vitrolife Sweden AB2003-06-23
JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900 (K031346)Jomed, Inc.2003-06-23
BERKELEY V-10 VACUUM CURETTAGE SYSTEM (K030935)Acmi Corporation2003-06-23
3TP SOFTWARE OPTION (K031350)3tp, LLC2003-06-23
SYRINGEX SAFETY SYRINGE, MODEL 0322G1.5 (K031065)Syringex Medical, Inc.2003-06-23
DEPUY ACROMED VBR SYSTEM (K031635)Depuyacromed2003-06-23
DATEX-OHMEDA HMEF 750 (K031653)Datex-Ohmeda2003-06-20
INTEGRADWEB BY DYNAMIC IMAGING, INC. (K031311)Dynamic Imaging, Inc.2003-06-20
EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL (K030944)Edwards Lifesciences, LLC2003-06-20
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM (K030963)Cordis Neurovascular, Inc.2003-06-20
C.CAM (K031825)Danish Diagnostic Development A/S2003-06-20
CTXA HIP EXTENDED REFERENCE DATA (K030330)Mindways Software, Inc.2003-06-20
SMITH & NEPHEW DYONICS ELECTROBLADE RESECTOR (K031675)Smith & Nephew, Inc.2003-06-20
ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY (K031606)Beckman Coulter, Inc.2003-06-20
REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406 (K024243)Fox Hollow Technologies2003-06-20
PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300 (K024259)New Star Lasers, Inc.2003-06-20
CONSULTIVA REPORT STATION, MODEL RS-1 (K031248)Miramedica, Inc.2003-06-20
TEMPORARY TITANIUM ANEURYSM CLIP (K031468)Cardinalhealth2003-06-20
SCANX 10 (K031198)Air Techniques, Inc.2003-06-20
AUTOBONE (K031871)Ge Medical Systems Europe2003-06-20
NLITE SYSTEM, MODEL#: A00-1025/A00-1033 (K024189)Icn Photonics , Ltd.2003-06-20
ULTRA-HIGH ENERGY GENERAL PURPOSE COLLIMATOR (UHGP) [FOR CARDIAC IMAGING] (K031872)Adac Laboratories2003-06-20
HF MODULE WITH TRANSDUCERS (K031391)Ophthalmic Technologies, Inc.2003-06-20
SENSE BODY COIL (K031095)Philips Medical Systems (Cleveland), Inc.2003-06-20
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT (K031626)AngioDynamics, Inc.2003-06-19
EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 (K031571)E-Z-Em, Inc.2003-06-19
C-1890 (K023896)Anodia Systems2003-06-19
CARE ETS (K023036)Care Rehab and Orthopaedic2003-06-19
HEMCON BANDAGE OTC; HEMCON CATH/AID (K030946)Hemcon, Inc.2003-06-19
UFI GEL HARD C (K030916)Voco GmbH2003-06-19
ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM (K031029)Arthrocare Corp.2003-06-19
DISPOSABLE M2-PE MICROKERATOME BLADES (K030401)Oasis Medical, Inc.2003-06-19
C-1805M (K023815)Anodia Systems2003-06-19
GENICON LAPAROSCOPES (K030174)Genicon, LC2003-06-19
FLUENCY TRACHEOBRONCHIAL STENT GRAFT (K031041)Bard Peripheral Vascular2003-06-19
DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M (K031177)Axis-Shield Diagnostics, Ltd.2003-06-19
MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND COMBINATION IPL SYSTEMS AND ND:YAG LASER SYSTEMS (K024093)Lumenis, Ltd.2003-06-19
CP MEDICAL BONE WAX (K024372)Cp Medical2003-06-19
SOLUTION FACE MASKS (K031353)A Plus International, Inc.2003-06-19
SKINSTATION (K030897)Radiancy (Israel) , Ltd.2003-06-19
PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV (K031164)Oscor, Inc.2003-06-19
INION OTPS BIODEGRADABLE FIXATON SYSTEM (K030900)Inion , Ltd.2003-06-19
GYNE IDEAS MINITAPE RP DEVICE (K023898)Gyne Ideas , Ltd.2003-06-18
DEMETECH NYLON NONABSORBABLE SUTURE (K023028)Demetech Corp.2003-06-18
LUMEND FRONTRUNNER GW CTO CATHETER (K031005)Lumend, Inc.2003-06-18
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT (K030654)Vascular Solutions, Inc.2003-06-18
DEMETECH POLYESTER NONABSORBABLE SUTURE (K023030)Demetech Corp.2003-06-18
QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010) (K023335)Qc Sciences, LLC2003-06-18
CURAD SCAR THERAPY (K024057)Beiersdorf, Inc.2003-06-18
ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03 (K031452)Ortho Tec, LLC2003-06-18
LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS (K031231)Bio-Rad2003-06-18
OMNILUX BLUE (K030883)Photo Therapeutics Limited2003-06-18
NIM-SPINE (K031510)Medtronic Xomed2003-06-18
INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY (K031605)Smith & Nephew, Inc.2003-06-18
ANDIODYNAMICS, INC. ELVS PROCEDURE KIT (K031233)AngioDynamics, Inc.2003-06-18
LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS (K031443)Lsi Solutions2003-06-18
ULTRA HIGH PRESSURE INJECTOR LINES (K023591)Deroyal Industries, Inc.2003-06-18
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Every clearance here is in the API, with alerts when new ones post.