Atlas FDA

2003

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

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RecordFirmDate
ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD (K033269)Ethicon Endo-Surgery, Inc.2003-12-10
STRYKER SPINE MAPS SYSTEM (K032855)Howmedica Osteonics2003-12-10
MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR (K032841)Moor Instruments, Ltd.2003-12-10
SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, AND EX8S3005 (K033537)Abbott Laboratories2003-12-10
GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING) (K032719)Gemore Technology Co, Ltd.2003-12-10
GEM-STIM TENS, MODELS GM3XY AND GM3AXY (K032720)Gemore Technology Co, Ltd.2003-12-10
SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS) (K033669)Smith & Nephew, Inc.2003-12-10
A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE (K032757)A-Dec, Inc.2003-12-10
EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT (K032953)Pulpdent Corporation2003-12-10
ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607 (K033544)Everyway Medical Instruments Co.,Ltd2003-12-10
ALLURA XPER FD20 (K033737)Philips Medical Systems North America, Inc.2003-12-09
SPIROTEL, MODEL 29-1020 (K031643)Sdi Diagnostics, Inc.2003-12-09
MONA LISA ASPIRATION NEEDLE (K032208)Fertility Technology Resources, Inc.2003-12-09
REDLINE ANTHRAX ALERT TEST (K030370)Tetracore, Inc.2003-12-09
MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM (K032690)Misonix, Inc.2003-12-09
LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400 (K033184)Shimadzu Corp.2003-12-09
OB1 OBSTETRICAL DOPPLER (K033156)D. E. Hokanson, Inc.2003-12-09
CD LEYCOM PRESSURE/VOLUME CATHETERS (K031599)Cd Leycom BV2003-12-09
FLUID FILLED TEETHERS (K031094)Royal King Infant Products Co. , Ltd.2003-12-08
POTENS + (K033137)Wada, Inc.2003-12-08
ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT (K032812)Orthovita, Inc.2003-12-08
GYNECARE TVT OBTURATOR SYSTEM (K033568)ETHICON, Inc.2003-12-08
MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER (K033613)Biotronik, Inc.2003-12-08
ACRA-CUT XPRESS 120 (K032970)Acra Cut, Inc.2003-12-08
AUTOGEL PAD (K031018)Rich-Mar Corp.2003-12-08
KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 (K032827)Tyco Healthcare2003-12-08
CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET (K033519)Biomet, Inc.2003-12-05
HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF (K032821)Hygia Health Services, Inc.2003-12-05
EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE (K033542)Galt Medical Corp.2003-12-05
MIDA ALGORITHM REV. B (K023414)Ortivus AB2003-12-05
IMMUNOCARDSTAT HPSA (K032222)Meridian Bioscience, Inc.2003-12-05
SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES (K031649)Fink Engineering Pty, Ltd.2003-12-05
BLUEPHASE (K033520)Ivoclar Vivadent, Inc.2003-12-05
VPT METER (K030829)Xilas Medical, Inc.2003-12-05
HDL-CHOLESTEROL PLUS 2ND GENERATION (K033610)Roche Diagnostics Corp.2003-12-05
DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE (K032810)Medtronic Heart Valves2003-12-05
LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS (K032900)Edwards Lifesciences, LLC2003-12-04
NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY (K032309)Novelens, Inc.2003-12-04
VISION-TECH YZ SLIT LAMP, MODEL 66 (K033190)Suzhou 66 Vision-Tech Co., Ltd.2003-12-04
UP-GRADE FOREHEAD THERMOMETER (K032362)Medisim, Ltd.2003-12-04
BOBCAT PRO SCALER SYSTEM, MODEL G-130 (K033705)Dentsply International2003-12-04
NON-CONTACT TONOMETER, MODEL NT-4000 (K031733)Nidek, Inc.2003-12-04
POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR (K031124)Datex-Ohmeda, Inc.2003-12-04
RANDOX RX DAYTONA (K024014)Randox Laboratories, Ltd.2003-12-04
MIRAGE ACTIVA MASK (K032916)Resmed, Ltd.2003-12-04
LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE (K033576)Abbott Laboratories2003-12-04
SENO ADVANTAGE (K033400)Ge Medical Systems W-4002003-12-04
LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSERTION KIT, ACCESS CANNILA (K023023)Vasca, Inc.2003-12-04
DEPUY ASR RESURFACING FEMORAL HEADS (K032659)DePuy Orthopaedics, Inc.2003-12-04
A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533 (K032756)A-Dec, Inc.2003-12-04
LAMITRODE SPINAL CORD STIMULATION LEADS (K033429)Advanced Neuromodulation Systems2003-12-04
CLC2000 CATHETER PATENCY DEVICE (K021692)Icu Medical, Inc.2003-12-04
DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS (K033516)DePuy Orthopaedics, Inc.2003-12-03
Z-SERIES MODULAR TOTAL HIP SYSTEM (K032729)Osteoimplant Technology, Inc.2003-12-03
LIGHTWAVE INFRARED LAMPS LW10D AND LW30D (K024027)Skytech Enterprises, Inc.2003-12-03
ASEPTICO ENDOPEX V, MODEL AEU-40 (K030895)Aseptico, Inc.2003-12-03
CANDELA SMOOTHBEAM LASER SYSTEM (K030834)Candela Corp.2003-12-03
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM (K033635)Ebi, L.P.2003-12-03
9 SECOND DIGITAL THERMOMETER, MODEL BT-S09 (K033082)Metatech Co., Ltd.2003-12-03
FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE (K031818)Facilai Enterprises , Ltd.2003-12-03
ADVANTAGE PADDLE (K033202)Livingston Products, Inc.2003-12-03
A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT (K032572)A-Dec, Inc.2003-12-03
ELPHA 4 CONTI (K032988)Danmeter A/S2003-12-03
VECTRA (INTELECT) EPR ULTRASOUND (K031116)Chattanooga Group2003-12-03
PERMAQUICK SE BONDING SYSTEM (K032626)Ultradent Products, Inc.2003-12-03
MODIFICATION TO TELEGRAPH HUMERAL NAIL (K033510)Fournitures Hospitalieres Industrie2003-12-03
R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM (K032752)R&B Surgical Solutions, LLC2003-12-03
TIE-IN TRAPEZIUM (K033529)Wrightmedicaltechnologyinc2003-12-03
MODIFICATION TO EQUATION FIXATION SYSTEM (K033495)Medtronic Sofamor Danek, Inc.2003-12-03
SPECTRA QT: Q-SWITCHED ND: YAG LASER SYSTEM (K032735)Max Engineering , Ltd.2003-12-03
NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR (K030485)Newmedical Technology, Inc.2003-12-03
LA500 BLUE LIGHT (K033201)Apoza Enterprise Co., Ltd.2003-12-02
SMITH & NEPHEW IUR MORCELLATION SYSTEM (K031787)Smith & Nephew, Inc.2003-12-02
PFZ PORCELAIN SYSTEM (K033553)Dentsply Intl.2003-12-02
WU'S 3-WHEELED NEO SCOOTER, WT-T3D (K032488)Wu'S Tech Co., Ltd.2003-12-02
TRSANSDERM IONTO SYSTEM (K032968)Mattioli Engineering Corp.2003-12-02
PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS (K033246)Roche Diagnostics Corp.2003-12-02
XIO RADIATION TREATMENT PLANNING SYSTEM (K032762)Computerized Medical Systems, Inc.2003-12-02
QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 (K033387)Bio-Rad2003-12-02
JUSTWIN SCOOTER, JS-3014 (K032645)Joy Ride Tech Co., Ltd.2003-12-02
TAIWAN KING STRONG TC 03 MECHANICAL WHEELCHAIR (K033031)Taiwan King Strong Co., Ltd.2003-12-02
STRYKER MINI-MENDER MENISCAL REPAIR SYSTEM (K032901)Stryker Endoscopy2003-12-02
CAP3 BONE SUBSTITUTE MATERIAL (K033138)Etex Corp.2003-12-02
TAIWAN KING STRONG POWERED WHEELCHAIR, TP 01 (K033100)Taiwan King Strong Co., Ltd.2003-12-02
JUSTWIN SCOOTER, JS-3013 (K032643)Joy Ride Tech Co., Ltd.2003-12-02
POLARIS WR (K031671)Syneron Medical, Ltd.2003-12-01
MICROLAB SPIROMETER (K031102)Micro Direct, Inc.2003-12-01
MULTI-STRAP FULL FACE MASK (K023683)Engineered Medical Systems2003-12-01
AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT (K032696)United States Surgical, A Division of Tyco Healthc2003-12-01
TRIHA + (K031826)Teknimed, S.A.2003-11-28
ARTHROCARE ARTHROWANDS (K033584)Arthrocare Corp.2003-11-28
MALIS IRRIGATION MODULE 1000 (K033499)Valley Forge Scientific Corp.2003-11-28
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL (K032865)W. L. Gore & Associates, Inc.2003-11-28
MULTICLEAR MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM (K032383)Curelight, Ltd.2003-11-28
POWERED WHEELCHAIR, MODEL FR168W (K033370)Freerider Corp2003-11-28
PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE) (K032716)Portex , Ltd.2003-11-28
MODIFICATION TO VERSABOND BONE CEMENT (K033509)Smith & Nephew, Inc.2003-11-28
MICRUS MICROCOIL SYSTEM (K032872)Micrus Corp.2003-11-28
BESMED VARIOUS MODELS OF TENS, BE-550/BE-660 (K031374)Besmed Health Business Corp2003-11-28
CWAS 1000 (K033452)Fasstech2003-11-28
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Every clearance here is in the API, with alerts when new ones post.