Atlas FDA

2006

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

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RecordFirmDate
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.12-16 UG/ML) (K053504)Dade Behring, Inc.2006-02-24
TRITON/TRU-TRAC/TX/TRITON DTS TRACTION (K053223)Chattanooga Group2006-02-24
CPS DIRECT SL OUTER CATHETER (K053277)St Jude Medical2006-02-24
ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P (K052732)Abracair, Inc.2006-02-24
PEDIATRIC URINARY CATHETER (K060268)Clay Kennard2006-02-24
CRYO, MODEL V6.0 (K060395)Zimmer Elektromedizin GmbH2006-02-24
ES-160 (K051020)Lhasa Oms, Inc.2006-02-24
GERATHERM SOS-RESCUE BLANKET (K051097)Rg Ent., Inc.2006-02-24
FILE-EZE (K060335)Ultradent Products, Inc.2006-02-24
REPROCESSED COMPRESSION SLEEVES (K060049)Alliance Medical Corp.2006-02-24
DISC-FX SYSTEM (K052241)Ellman International, Inc.2006-02-24
CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM (K060350)Blackstone Medical, Inc.2006-02-24
MAKO SURGICAL UNICONDYLAR KNEE SYSTEM (K060017)Mako Surgical Corp.2006-02-23
LOOP RECORDER VITAPHONE, 3100 SERIES (K053378)Tms Telemedizinische Systeme GmbH2006-02-23
BIO-MINI REVO SUTURE ANCHOR (K053561)Conmed Linvatec2006-02-23
FLEXISCOPE, MODELS 50MH AND 50 MHC (K053412)Schoelly Imaging, Inc.2006-02-23
FLEX-AID LIQUID GEL BANDAGE AND DERMAFLEX GEL TISSUE ADHESIVE PROFESSIONAL LIQUID BANDAGE (K050757)Chemence Medical, Inc.2006-02-23
BIORAPTOR SUTURE ANCHOR, TWINFIX 2.8 MM SUTURE ANCHOR, TWINFIX 3.5 MM SUTURE ANCHOR (K053344)Smith & Nephew, Inc.2006-02-23
HALUX IRIS EXAMINATION AND SURGICAL LAMP (K053364)Waldmann Lighting2006-02-23
POCKET BREATHALYZER. CONNECTABLES (K052448)Connectables, LLC2006-02-23
STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST. (K060253)Regeneration Technologies, Inc.2006-02-23
SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM (K060150)Andante Medical Devices , Ltd.2006-02-23
GI DENTSTAT (K060334)Ultradent Products, Inc.2006-02-23
FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H, (K052617)Good Biotech Corp.2006-02-23
PROCERA BRIDGE ZIRCONIA (K053125)Nobel Biocare AB2006-02-22
NASALGUARD (K053625)Trutek Corp2006-02-22
DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 2121 (K060259)Ge Medical Systems, LLC2006-02-22
POPMESH (K053424)Caldera Medical, Inc.2006-02-22
ISSYS DRUG FLOW MONITOR (K050783)Integrated Sensing Systems, Inc.2006-02-22
OSSIX -PLUS (K053260)Colbar Lifescience , Ltd.2006-02-22
WAVELIGHT IDAS (K053604)Wavelight Laser Technologie AG2006-02-22
PROCERA BRIDGE LAMINATE, MODEL 40-4002 (K053068)Nobel Biocare AB2006-02-22
TRANSET SYSTEM (K060283)Bonutti Research, Inc.2006-02-22
CALDERA MESH (K060004)Caldera Medical, Inc.2006-02-22
BERRY FRUITY TEETHER (K053493)Evenflo Company, Inc.2006-02-22
BOVIE BUTTON REMOTE HAND SWITCH (K060117)Aaron Medical Industries2006-02-22
DERMACYN WOUND CARE (K060113)Oculus Innovative Sciences, Inc.2006-02-22
PROCERA BRIDGE ALUMINA (K053050)Nobel Biocare AB2006-02-22
INFINITY GAMMA / GAMMAXL, INFINITY VISTA (K053484)Draeger Medical Systems, Inc.2006-02-22
GENZYME OSOM INFLUENZA A & B TEST (K051244)Genzyme Corp.2006-02-21
ACL ELITE; ACL ELITE PRO (K060162)Instrumentation Laboratory CO2006-02-21
IMPLANTIUM ABUTMENTS (K052823)Dentium, Inc.2006-02-21
MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM (K053635)Bionime Corporation2006-02-21
MALE NATURAL RUBBER LATEX CONDOM (K053367)Innolatex Sdn. Bhd2006-02-21
OSSAPLAST DENTAL (PARTICLE SIZE OF 500 TO 1000 UM TO 2000 UM) (K053374)Ossacur AG2006-02-21
DART-12 (K052705)Direx Systems Corp.2006-02-21
CEPH, MODEL 4900 (K053558)Schick Technologies, Inc.2006-02-17
DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT) (K052828)Hospira, Inc.2006-02-17
SPIDERX EMBOLIC PROTECTION DEVICE (K052659)Ev3, Inc.2006-02-17
LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR (K052057)Medtronic Emergency Response Systems, Inc.2006-02-17
KD-322 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR (K052676)Kodon(Tianjin)Electronic&Electrical Apparatus Co.,2006-02-17
XR-SERIES BI-METRIC FEMORAL COMPONENTS (K052089)Biomet Manufacturing, Inc.2006-02-17
CAMLOG DENTAL IMPLANT ABUTMENTS, HEALING CAPS, AND ACCESSORIES (K051636)Altatec GmbH2006-02-17
TITAN STEERABLE (PTCA) GUIDEWIRE (K052347)Lake Region Mfg., Inc.2006-02-17
ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM) (K060019)Artron Laboratories, Inc.2006-02-17
TEMPORARY CROWN AND BRIDGE MATERIAL (K060293)Dentsply International, Inc.2006-02-17
RX EPIDURAL NEEDLE (K053318)Epimed International, Inc.2006-02-17
CXR16 (K053148)Hitachi Medical Systems America, Inc.2006-02-17
CIV-OB OBSTRICAL MONITORING SOFTWARE APPLICATION (K051175)Civent Communications, Ltd.2006-02-17
ARX SPINAL SYSTEM (K051525)Amedica Corp.2006-02-17
SPECTRUM FIVE LUMEN CENTRAL VENOUS CATHETER SET, MODEL C-UQLM10.0-ABRM (K060174)Cook, Inc.2006-02-17
HEMOCUE ALBUMIN 201 ANALYZING SYSTEM (K053253)Hemocue AB2006-02-17
NUVASIVE SMARTPLATE GRADIENT PLUS SYSTEM (K053581)Nuvasive, Inc.2006-02-17
BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING (K050086)Brennen Medical, Inc.2006-02-17
THE PHILLIPS, MODEL MP20,MP30,MP40,MP50,MP60,MP70,MP80,AND MP90 INTELLIVUE PATIENT MONITORS (K060221)Philips Medizin Systeme Boeblingen GmbH2006-02-17
ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVES (K060091)Alliance Medical Corp.2006-02-17
K-Y BRAND SENSUAL MIST (K053397)Mcneil-Ppc, Inc.2006-02-17
AXCEL (K051931)Tri Dental Innovators2006-02-17
ERBE APC INTEGRATED FILTER PROBES; ERBE APC INTEGRATED FILTER PROBE ADAPTER (K060183)Erbe USA, Inc.2006-02-16
FOTONA QX ND:YAG/KTP LASER SYSTEM (K053139)Fotona D.D.2006-02-16
TBR IDEA CONIC/CONIC (K050956)Sudimplant SA2006-02-16
JIVE X SOFTWARE (K053183)Visus Technology Transfer GmbH2006-02-16
ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS (K053293)Ortho Development Corp.2006-02-16
MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC. (K052168)Medline Industries, Inc.2006-02-16
HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310 (K053512)Baxter Healthcare Corp2006-02-16
DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108 (K053108)Dade Behring, Inc.2006-02-16
ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS (K060170)Erbe USA, Inc.2006-02-16
CHUNG CHENG FAR INFRARED RAY HEALTHFUL LAMP (OR MEDICAL FIR RADIATOR), MODEL CH-8810 (K053376)Chung Cheng Electric Heating Co., Ltd.2006-02-16
EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM (K051489)Euroimmun Us, LLC2006-02-16
COBAS INTEGRA CHLORIDE ELCTRODE GEN.2 (K060108)Roche Diagnostics Corp.2006-02-16
ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET (K060133)Inverness Medical Innovations, Inc.2006-02-16
GORE-TEX NON-STERILE SURGICAL GOWNS (K052833)Medline Industries, Inc.2006-02-15
AESCULAP STERILCONTAINER SYSTEM (K053389)Aesculap, Inc.2006-02-15
OSS-BODIES PROXIMAL TIBIAL SLEEVE (K060131)Biomet Manufacturing Corp2006-02-15
VERSYS EPOCH FULLCOAT HIP PROSTHESIS (K052321)Zimmer, Inc.2006-02-15
I-D GLIDE (K051295)Westridge Laboratories, Inc.2006-02-15
KORLEX-GR GINGIVAL RETRACTION PASTE (K053329)Biotech One, Inc.2006-02-15
MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A (K053566)Diazyme Laboratories2006-02-15
FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE (K052882)Tianjin New Bay Bioresearch Co., Ltd.2006-02-15
HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVES/FOOT CUFFS (K053575)Hygia Health Services, Inc.2006-02-15
THE ELITE - ULTRA-LIGHT, COMPACT PORTABLE SCOOTER (K052204)Tzora Active Systems , Ltd.2006-02-15
CONTISTIM CONTINUOUS STIMULATING CATHETER NERVE BLOCK SET (K052954)Life-Tech, Inc.2006-02-15
RAVEN PROPACT (K053212)Raven Biological Laboratories, Inc.2006-02-15
X-TRA FIL (K053391)Voco GmbH2006-02-15
COMFORTLITE NASAL MASK (K053352)Respironics, Inc.2006-02-15
LANDLEX, MODEL P100X (K060042)Besteam Technology, Inc.2006-02-14
PERIOGLAS BONE GRAFT PARTICULATE (K053387)Novabone Products, LLC2006-02-14
BIOHORIZONS PLASTIC TEMPORARY ABUTMENTS (K053099)BioHorizons Implant Systems, Inc.2006-02-14
LEVELERT II FLUID LEVEL SENSOR (K060123)Smith & Nephew, Inc.2006-02-14
POWDER FREE STERILE VINYL GLOVE (CLEAR AND YELLOW) (K053523)Shijiazhuang Hongxiang Plastics Products Co., Ltd.2006-02-14
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