Atlas FDA

2001

3,494 FDA 510(k) clearances · Clearance year

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RecordFirmDate
HARDYDISK RIFAMPIN, 5MCG (K003537)Hardy Diagnostics2001-01-12
CBC-4K HEMATOLOGY CONTROL (K003874)R&D Systems, Inc.2001-01-12
PORTABLE BREAST COMPRESSION DEVICE (K003775)Pem Technologies2001-01-12
MS-ONE, MODEL MS-1 (K003258)Home Wellness West2001-01-12
MEDICAL DEPOT-WHEELCHAIRS, MODEL SENTRA,ASTAIRE AND VIPER (K003783)Medical Depot, Inc.2001-01-12
MAXIM KNEE SYSTEM (K010027)Biomet, Inc.2001-01-12
HMS NEUROMUSCULAR STIMULATOR, MODEL HMS 3 (K003231)Home Medical Services2001-01-12
MPS ACACIA PAIN KIT (K003476)Mps Acacia2001-01-12
GENUA MENOPAUSE MONITOR TEST KIT (K002450)Genua 1944, Inc.2001-01-12
2-PIECE POST AND CORE FOR THE B.A.S.I.C. DENTAL IMPLANT SYSTEM (K001259)Basic Dental Implant Systems, Inc.2001-01-12
!NSURE FECAL OCCULT BLOOD TEST (K002457)Enterix, Inc.2001-01-12
ELECSYS CA 125 II CALSET (K003969)Roche Diagnostics Corp.2001-01-12
CONTOUR LABRAL NAIL, MODEL 533520A (K003970)Bionx Implants, Inc.2001-01-12
TE-2000 POWER TILT/POWER ELEVATING SEAT COMBINATION SYSTEM (K010011)Accelerated Rehab Designs, Inc.2001-01-12
HARDYDISK TICARCILLIN/CLAVULANIC ACID, 85MCG (K003686)Hardy Diagnostics2001-01-12
MICRUS MICROCOIL DELIVERY SYSTEM, MDS03 (K002056)Micrus Corp.2001-01-11
COSMED QUARK (K001174)Cosmed Srl2001-01-11
HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST (K003848)Howmedica Osteonics Corp.2001-01-11
MULTITRACK ANGIOGRAPHIC CATHETER (K003902)NuMED, Inc.2001-01-11
PENILE CONSTRICTOR RING (K001859)Basic Solutions, LLC2001-01-11
NUMED GHOST II PTA CATHETERS (K003972)NuMED, Inc.2001-01-11
FILAC FAS TEMP ELECTRONIC THERMOMETER (K003313)The Kendall Company2001-01-11
LACTOSORB SCREW ANCHOR (K003273)Biomet, Inc.2001-01-11
RADIANALYZER, MODEL 12710 (K002067)Radi Medical Systems AB2001-01-11
CARE PROVIDER STATION ADDITION OF WEIGHT SCALE (K003485)Cybercare Technologies, Inc.2001-01-11
AVANTE CURELIGHT (K003683)Jeneric/Pentron, Inc.2001-01-11
MICROSTREAM EXTERNAL BATTERY CHARGER (K002163)Oridion Medical 1987 , Ltd.2001-01-11
TAXOL ADMINISTRATION SET (K003513)Icu Medical, Inc.2001-01-11
PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES (K002381)Pentaferte, S.R.L.2001-01-11
BURN JEL PLUS (K003396)Water-Jel Technologies, LLC2001-01-11
OUTBACK CATHETER (K001577)Lumend, Inc.2001-01-11
TRIAD II MODULAR TOTAL HIP SYSTEM (K003199)Osteoimplant Technology, Inc.2001-01-10
BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G, ALBABOND, BIO MAINGOLD SG, MAINGOLD SG, HE (K003603)Jelenko Co.2001-01-10
U2 HIP STEM, TI POROUS COATED (K003237)United Orthopedic Corp.2001-01-10
FAMILY OF ALTUS MEDICAL COOLGLIDE AESTHETIC LASERS, MODELS I & II (K003202)Altus Medical2001-01-10
BARD MEMOTHERM ENDOSCOPIC BILIARY STENT (K003186)C.R. Bard, Inc.2001-01-09
PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES (K003072)Biotronik, Inc.2001-01-09
VENODYNE DVT ADVANTAGE MODEL 610 (K001802)Microtek Medical, Inc.2001-01-09
AUROFILM NP (K003387)Metalor Dental USA Corp.2001-01-09
SYNTHES (USA) RESORBABLE TACK SYSTEM (K000560)Synthes (Usa)2001-01-09
DRIED GRAM-POSITIVE MIC/COMBO PANELS (K003619)Dade Microscan, Inc.2001-01-09
RAPIDD HIGHSPEED DENTAL HANDPIECE (K003518)Dentsply Intl.2001-01-09
UNIGRAFT (K003457)Unicare Biomedical2001-01-09
SHANGHAI CHINA STAR CORP POWDERED BLUE NITRILE PATIENT EXAMINATION GLOVES (K003675)Shanghai China Star Corp2001-01-09
BIO-ABSORBABLE CORKSCREW MODEL AR-1920B (K003227)Arthrex, Inc.2001-01-08
STICK NET (K003334)Stick Tech , Ltd.2001-01-08
ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER (K002603)Zcv ,Inc.2001-01-08
TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM (K003164)Richard Wolf Medical Instruments Corp.2001-01-08
FLEXIBLE OCCLUSION SYSTEM (K002915)Applied Medical2001-01-08
MICROPOBE SERIES OF LASERS AND ACCESSORIES (K003151)Endooptiks, Inc.2001-01-08
KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ ECG 110 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS WITH EC (K001896)Suzuken Co., Ltd.2001-01-08
PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION (K003827)Bio-Plexus, Inc.2001-01-08
ISOLA CLOSED DUAL ROD CONNECTOR (K003822)Depuyacromed2001-01-08
COLLAGEN PERIODONTAL MEMBRANE (K003339)Collagen Matrix, Inc.2001-01-08
PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS (K003925)Cordis Neurovascular, Inc.2001-01-08
STERILE PISTON SYRINGE (K002717)Abbott Laboratories2001-01-08
INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS (K990800)Intervascular, Inc.2001-01-08
OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAILY WEAR SOFT CONTACT LENS (K003136)Ocular Sciences Puerto Rico, Inc.2001-01-06
MONARCH II IOL DELIVERY SYSTEM (K003768)Alcon Research, Ltd.2001-01-05
BARD LUMINEXX BILIARY STENT (K003793)C.R. Bard, Inc.2001-01-05
MIZAR, BASIS BE, SANDMAN DIGITAL (K003154)Eb Neuro S.P.A.2001-01-05
LENSOCLEAN MULTI-PURPOSE SOLUTION, MODEL 355ML (K003031)Alpha Vista, Inc.2001-01-05
BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED); BARDEX LUBRI-SIL TEMPERATURE-SENSING FOLEY CATHETER (LU (K003289)C.R. Bard, Inc.2001-01-05
2010 PLUS HOLTER FOR WINDOWS (K003763)Agilent Technologies2001-01-05
KELO-COTE TOPICAL GEL (K002488)Advanced Bio-Technologies, Inc.2001-01-05
260 CORVUS (K003292)Pie Medical2001-01-05
BARD ENDOCINCH SUTURING SYSTEM # 000452; 000454; 000595 (K003956)C.R. Bard, Inc.2001-01-05
VERTEBRAL BODY REPLACEMENT (K003155)Osteotech, Inc.2001-01-04
UNICONDYLAR INTERPOSITIONAL SPACER (K003269)Sulzer Orthopedics, Inc.2001-01-04
PALFIQUE ESTELITE LV (K002863)Tokuyama America, Inc.2001-01-04
BIOEMG II AND BIOJVA (K003176)Bio-Research Associates, Inc.2001-01-04
ORION PLATINUM (K003367)Srs Medical Systems, Inc.2001-01-04
GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE (K003753)Uresil Corp.2001-01-04
FRESENIUS OPTIFLUX 200A (K003498)Fresenius Medical Care North America2001-01-04
SULZER ORTHOPEDICS ANATOMICAL SHOULDER CEMENTED HUMERAL STEM (K003832)Sulzer Orthopedics, Inc.2001-01-04
STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES (K003111)Stryker Instruments2001-01-04
TEMP-BOND NE 2 (K003658)Sybron Dental Specialties, Inc.2001-01-04
ERBE APC HANDLE AND APPLICATORS, MODEL 20132-043,20132-031,20132-032,20132-033,20132-034,20132-040,20132-044,20132-045 (K003462)Erbe USA, Inc.2001-01-04
STICK (K003333)Stick Tech , Ltd.2001-01-04
EBI VUECATH SPINAL ENDOSCOPIC SYSTEM (K003898)Ebi, L.P.2001-01-04
AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC) (K003330)Aktina Medical Physics Corp.2001-01-04
ELECTROSURGICAL PROBES AND DEVICES-GELTX (K002269)Ximed/Prosure/Injectx2001-01-04
REGAIN DESKTOP (K003127)Srs Medical Systems, Inc.2001-01-04
PHACOGARD (K002932)Syntec, Inc.2001-01-04
ASTRA TECH IMPLANTS - DENTAL SYSTEM (K002513)Astra Tech, Inc.2001-01-04
ULTIMUM EV HEMOSTASIS INTRODUCER (14F), ULTIMUM EV HEMOSTASIS INTRODUCER (16F), ULTIMUM EV HEMOSTASIS INTRODUCER (18F), (K003729)St Jude Medical2001-01-03
BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES (K003756)Bionx Implants, Inc.2001-01-03
ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE (K003415)Wang & Li, Inc.2001-01-03
CASTLE MODEL 233HC STEAM STERILIZER (K003441)Getinge/Castle, Inc.2001-01-02
MODIFICATION TO EBI SPINELINK SYSTEM (K003764)Ebi, L.P.2001-01-02
WATER PURIFICATION SYSTEM (K994292)Water & Power Technologies, Inc.2001-01-02
POWDER-FREE NITRILE EXAM GLOVE, LAVENDER/PURPLE (K003563)Ning BO Yujiang Rubber & Plastic Co.2001-01-02
FLEXICAST (K003509)American Dent-All, Inc.2001-01-02
DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T (K003451)Denver Biomedicals, Inc.2001-01-02
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Every clearance here is in the API, with alerts when new ones post.