Atlas FDA

2004

3,373 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SMART KLAMP VARIOUS BY SIZE (K032091)Emergogroup, Inc.2004-03-08
PANORET, MODEL PNM 60 (K040325)Medibell Medical Vision Technologies , Ltd.2004-03-08
QUANTA PLEX SLE PROFILE 8 (K040160)Inova Diagnostics, Inc.2004-03-08
MODIFICATION TO E.P.T. PREGNANCY TEST (K040329)Unipath , Ltd.2004-03-08
CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST (K040341)Unipath , Ltd.2004-03-08
VITALAB MAGNESIUM REAGENT (K040508)Clinical Data, Inc.2004-03-08
ZTI IMPLANTS SYSTEM, DRM IMPLANTS (K034067)Drm Research Laboratories, Inc.2004-03-08
CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY (K040405)Berkeley Advanced Biomaterials, Inc.2004-03-05
ALLOMATRIX MODEL# 86 (K020895)Wrightmedicaltechnologyinc2004-03-05
I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2 (K033136)Innova Vision, Inc.2004-03-05
TI CLIP APPLIER (K034029)Gyrx, LLC2004-03-05
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT (K040446)AngioDynamics, Inc.2004-03-05
AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE (K032278)Ambu, Inc.2004-03-05
COLONOSIGHT MODEL 510B (K032688)Sightline Technologies , Ltd.2004-03-05
QSC-127-INT SHOULDER ARRAY COIL SET (K040288)Mri Devices Corp.2004-03-05
SPI CONTACT DENTAL IMPLANT (K034014)Thommen Medical AG2004-03-05
INTEGRAL HEMODIALYSIS CATHETER (K040260)Arrow Int'L.2004-03-05
DYNESYS SPINAL SYSTEM (K031511)Centerpulse Spine-Tech, Inc.2004-03-05
NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM (K033810)Centerpulse Orthopedics, Inc.2004-03-05
TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002 (K033410)Remote Diagnostic Technologies , Ltd.2004-03-05
SIMIDUR SUPERIOR (K040436)Wieland Dental + Technik GmbH & Co. KG2004-03-05
LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS (K040455)Cliniqa Corporation2004-03-05
IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA (K040095)Immco Diagnostics, Inc.2004-03-05
PAJUNK MODULAR HANDLE INSTRUMENTS (K033249)Pajunk GmbH2004-03-05
LABONE COCAINE METABOLITE MICRO-PLATE EIA (K040198)Labone, Inc.2004-03-05
NUBERT, ALBERT AND HUBERT IMPERVIOUS BAGS FOR ENDOSCOPIC RETRIEVAL OF TISSUE (K033842)Vernon-Carus Limited2004-03-04
BIPAP PRO 2 BI-LEVEL SYSTEM (K032834)Respironics, Inc.2004-03-04
HIOX80 AEROSOL ADAPTER (K032516)Sensor Medics Corp.2004-03-04
SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM) (K032454)Bio-Lok Intl., Inc.2004-03-04
LYPHOCHEK ASSAYED CHEMISTRY CONTROL (K040273)Bio-Rad Laboratories, Inc.2004-03-04
PRESSURE MANIFOLD, MODEL BC 110 (K040366)Fisher & Paykel Healthcare, Ltd.2004-03-04
CONTINUM V (K040180)Aalba Dent, Inc.2004-03-04
SHIRAZ-ANTERIOR SYSTEM (K033965)Spine Next America2004-03-04
IV ADMINISTRATION AND CONNECT SETS (K033301)Codan US Corp.2004-03-04
TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000H (K040507)Taga Medical Technologies, Inc.2004-03-04
CALIBRATING MATERIAL, CALIBRATING STANDARDS (K033060)Diamond Diagnostics, Inc.2004-03-04
MESACUP-2 TEST CENP-B (K040200)Rhigene, Inc.2004-03-04
SYNTHES VENTROFIX MIS SYSTEM (K031100)Synthes (Usa)2004-03-04
SHIRAZ POSTERIOR SYSTEM (K033947)Spine Next America2004-03-04
B.BRAUN PREMIXED DIALYSATE (K034066)B.Braun Medical, Inc.2004-03-03
BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION) (K033980)Blackstone Medical, Inc.2004-03-03
RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568 (K031903)Guidant Corporation2004-03-03
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) (K040300)Stryker Instruments2004-03-03
HIGH SPEED EMG MODULE (K031930)Medical Measurement Systems B.V.2004-03-03
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM (K040037)Intra Luminal Therapeutics, Inc.2004-03-03
POWDERED LATEX EXAMINATION GLOVES (K033531)Apl International Incorporated Limited2004-03-03
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A TELEMETRY MONITORING SYSTEM II (K040357)Philips Medical Systems, Inc.2004-03-03
DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE (K034004)Gyrus Ent LLC2004-03-03
CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR (K040210)Terumo Corp.2004-03-03
PLUME SAFETY AVF NEEDLE (K040247)Jms North America Corp.2004-03-03
PM-8000 PATIENT MONITOR, MODEL 8000 (K032733)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2004-03-03
PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA (K031114)Raven Biological Laboratories, Inc.2004-03-03
TIARA MEDICAL SYSTEMS ADVANTAGE II NASAL MASK, MODELS TMS-2520 AND TMS-2530 (K031935)Tiara Medical Systems, Inc.2004-03-03
NDX-40 ALLOY (K040043)Heraeus Kulzer, Inc.2004-03-03
CONTINUM (K040179)Aalba Dent, Inc.2004-03-03
ATRION MEDICAL QL INFLATION DEVICE (K032840)Atrion Medical Products, Inc.2004-03-03
VIVARING MICROWAVE ABLATION PROBE (K040279)Vivant Medical, Inc.2004-03-02
THE FRIENDLYLIGHT ND: YAG LASERS (K033251)Innotech USA, Inc.2004-03-02
A1C-CELLULAR (K040025)Streck Laboratories, Inc.2004-03-02
MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE (K033881)Medrad, Inc.2004-03-02
NON-STERILE BLUE & WHITE COLOUR POWDER FREE BARRIER PRO POLYBUTADIENE COPOLYMER EXAMINATION GLOVES (K033887)Yty Industry (Manjung) Sdn Bhd2004-03-02
NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BG (K023342)Hdc Corp.2004-03-02
NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000 (K033619)Image-Guided Neurologics, Inc.2004-03-02
CT OIA (K032330)Thermo Biostar, Inc.2004-03-02
CT-MASS (K033774)Medis Medical Imaging Systems BV2004-03-02
MODIFICATION TO NITREX NITINOL GUIDEWIRE (K040345)Ev3, Inc.2004-03-02
SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM (K033816)Synthes (Usa)2004-03-02
KENKOWAVE INFRARED PAIN TREATMENT SYSTEM (K033555)Kaylight Corporation2004-03-02
DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G) (K033851)Hypoguard USA, Inc.2004-03-02
ARROW ECHOGENIC INTRODUCER NEEDLE (K040100)Arrow Intl., Inc.2004-03-01
KOMPRESSOR SCREW SYSTEM (K040356)Kinetikos Medical, Inc.2004-03-01
LIGHTSPEED 7.0 CT SCANNER SYSTEM (K040372)Ge Medical Systems, LLC2004-03-01
CAPIOX FLEXIBLE VENOUS RESERVOIR (K040023)Terumo Cardiovascular Systems Corp.2004-03-01
BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007 (K033814)C.R. Bard, Inc.2004-03-01
MODIFIED SONAMET BODY COMPOSITION ANALYZER (K032610)Life Measurement, Inc.2004-03-01
ARTHROCARE CONTROLLER, CABLE, FOOT CONTROL, POWER CORD, WANDS, MODELS H0970-02, H2000-04, H2000-05, H0970-06 (K040338)Arthrocare Corp.2004-03-01
LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999 (K040232)Lsi Solutions2004-03-01
TRAPMATIC SYSTEM SET (K033616)H.S Hospital Service S.P.A2004-03-01
BILOK ST SCREW (K033792)Biocomposites, Ltd.2004-03-01
INION OTPS BIODEGRADABLE MESH PLATING SYSTEM (K031961)Inion , Ltd.2004-03-01
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFEPIME (GN) 0.5-65 UG/ML (K032675)Becton, Dickinson & CO2004-03-01
PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP40 & MP50 (K040304)Philips Medizin Systeme Boeblingen GmbH2004-03-01
ART POSTERIOR SPINAL SYSTEM (K033150)Advanced Medical Technologies AG2004-03-01
3.5 MM LCP DISTAL HUMERUS SYSTEM (K033995)Synthes (Usa)2004-03-01
IMALUX OCT IMAGING SYSTEM (K033783)Imalux Coporation2004-03-01
HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM (K034049)Heraeus Kulzer,GmbH2004-03-01
SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS (K033975)Synthes (Usa)2004-03-01
CLO-SURPLUSP.A.D. (K032986)Scion Cardio-Vascular, Inc.2004-03-01
VITAL SIGNS MONITOR, PROPAQ LT (K033378)Welch Allyn Protocol, Inc.2004-03-01
CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365 (K023684)Vilex, Inc.2004-03-01
SP NEWTRON MODULE (K033764)Satelec2004-03-01
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN) (K033948)Dade Behring, Inc.2004-03-01
PERIOGLAS-BIOGLASS BONE GRAFT SUBSTITUTE (K040278)Novabone Products, LLC2004-03-01
EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY (K033617)Vasomedical, Inc.2004-03-01
MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING (K040211)Collagen Matrix, Inc.2004-02-27
ON-BOARD IMAGER DEVICE (K040192)Varian Medical Systems, Inc.2004-02-27
ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM (K033802)Zeus Scientific, Inc.2004-02-27
TRANSVAGINAL ENDOSCOPY SET (K033728)KARL STORZ Endoscopy-America, Inc.2004-02-27
KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM (K034027)KLS-Martin L.P.2004-02-27
EP-4 CLINICAL STIMULATOR (K040207)Ep Medsystems2004-02-27
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Every clearance here is in the API, with alerts when new ones post.