Atlas FDA

2003

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

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RecordFirmDate
GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM (K023878)Medtronic Vascular2003-01-24
PICUS ULTRASOUND IMAGING SYSTEMS (K023512)Pie Medical2003-01-24
NITREX NITINOL GUIDEWIRE (K024021)Ev3 Corporation2003-01-24
BURBANK TENACULUM, MODEL 09-0011-01 (K030078)Vascular Control Systems, Inc.2003-01-24
UCP DENTAL MATERIAL (K023831)Precious Chemicals U.S.A., Inc.2003-01-24
SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE-BLUE COLOR (K023826)Syntex Healthcare Products Co., Ltd.2003-01-24
MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE (K030019)Guidant Corp.2003-01-24
PICCOLO TOTAL CHOLESTEROL TEST SYSTEM (K023642)Abaxis, Inc.2003-01-24
INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PLEVIS COIL (K023650)Usa Instruments, Inc.2003-01-24
MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES (K030179)Surgical Instruments Service and Savings, Inc.2003-01-24
SILVERLON CONTACT WOUND DRESSING (K023612)Argentum International, LLC2003-01-24
PICCOLO HDL TEST SYSTEM (K023640)Abaxis, Inc.2003-01-24
WU'S 3-WHEELED NEO SCOOTER, WT-M4 (K023166)Wu'S Tech Co., Ltd.2003-01-24
IVUS PLUS (K024103)Indec Systems, Inc.2003-01-24
H2 HEATED HUMIDIFIER (K030090)Respironics, Inc.2003-01-24
MOSS MIAMI SPINAL SYSTEM PIN NUT (K023804)Depuyacromed2003-01-23
DRX3000 (K022602)Axiom Usa., Inc.2003-01-23
FREEDOM CONSTRAINED LINERS (K030047)Biomet, Inc.2003-01-23
DIMISIL SCAR GEL (K023678)Aesthetic and Reconstructive Technologies, Inc.2003-01-23
XENO III DENTAL ADHESIVE (K023776)Dentsply Intl.2003-01-23
ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL (K024234)Bayer Corp.2003-01-23
TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS (K030089)Biosite Incorporated2003-01-23
SYNTHES TOMOFIX OSTEOTOMY SYSTEM (K023941)Synthes (Usa)2003-01-23
LUMEND FRONTRUNNER CTO CATHETER (K023114)Lumend, Inc.2003-01-23
SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM (K024326)Spinal Concepts, Inc.2003-01-23
RAPID THERMAL EXCHANGE SYSTEM (K023934)Avacore Technologies, Inc.2003-01-23
SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM (K023743)Smith & Nephew, Inc.2003-01-23
OSTEO-CABLE SLEEVE (K024022)Biomet, Inc.2003-01-23
AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036 (K023613)Alphatek Corp.2003-01-23
BARD ER URETERAL STENT WITH SUTURE (K022447)C.R. Bard, Inc.2003-01-23
INTERPORE CROSS INTERNATIONAL ANTERIOR FIXATION DEVICE (AFD) (K022143)Interpore Cross Intl.2003-01-23
NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM (K023128)Secure Scientific Sdn Bhd2003-01-22
MODIFICATION TO EBI XFIX DFS SYSTEM METAPHYSEAL CORRECTION SYSTEM (K024248)Ebi, L.P.2003-01-22
SONICAID ONE (K023618)Oxford Instruments Medical , Ltd.2003-01-22
EXAJET (K023751)GC America, Inc.2003-01-22
ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER (K024177)Johnson & Johnson Vision Care, Inc.2003-01-22
CANDELA SMOOTHBEAM LASER SYSTEM (K022884)Candela Corp.2003-01-22
COOPERSURGICAL OOCYTE RECOVERY NEEDLES (K023930)CooperSurgical, Inc.2003-01-22
EXEL SECURETOUCH PTP SYRINGE (K011754)Exelint Intl. Co.2003-01-22
ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY (K030064)Sonosite,Inc.2003-01-22
SYDNEY IVF EMBRYO BIOPSY MEDIUM (K023850)Cook Ob/Gyn2003-01-22
STRYKER NAVIGATION SYSTEM - HIP MODULE (K022365)Stryker Instruments2003-01-22
CONCERT CRANIOPLAST (K023575)Immedica, Inc.2003-01-22
FREELITE HUMAN LAMBDA FREE KIT (K023131)The Binding Site, Ltd.2003-01-21
UCC DENTAL MATERIAL (K023790)Precious Chemicals U.S.A., Inc.2003-01-21
INNER-LOCK LOCKING INTRODUCER SHEATHS (K022170)Rex Medical2003-01-21
COMPUMEDICS SOMTE SYSTEM (K021176)Compumedics Limited2003-01-21
EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830 (K010714)Medi-Globe Corp.2003-01-21
LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS (K030074)Cliniqa Corporation2003-01-21
FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZER (K023009)The Binding Site, Ltd.2003-01-21
BOUSSIGNAC C.P.A.P. DEVICE (K013884)Vygon SA2003-01-21
PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT) (K023795)Lin-Zhi International, Inc.2003-01-21
STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM (K023580)Sterngold2003-01-17
VISORB SWIFT (K023710)Cp Medical2003-01-17
GLUCOSE-SL-C ASSAY, MODEL 257-30 (K023739)Diagnostic Chemicals , Ltd.2003-01-17
THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM (K024020)Theralight, Inc.2003-01-17
SCULPTURE PLUS NANO-HYBRID COMPOSITE (K023742)Pentron Laboratory Technologies2003-01-17
OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB (K022035)Osteomedics, Inc.2003-01-17
AVANT GUARDIAN 101 (K024018)Avant Medical Corporation2003-01-17
BARCO MEDIS 5MP2 AURA (K023533)Barco N.V.2003-01-17
LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 (K024218)Bio-Rad2003-01-17
TRIPTER X-1 COMPACT DUET (K023535)Direx Systems Corp.2003-01-17
MAXONE IV FLUID/BLOOD WARMER, MODEL 102 (K023653)Automatic Medical Technologies, Inc.2003-01-17
CPC BY SORING GMBH (K030028)Soring GmbH Medizintechnik2003-01-17
CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372 (K030012)Beckman Coulter, Inc.2003-01-17
SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G (K023745)Sechrist Industries, Inc.2003-01-17
SILVERLON ADHESIVE STRIP (K023609)Argentum International, LLC2003-01-17
COALESCENT SURGICAL U-CLIP AND ACCESSORIES (K024366)Coalescent Surgical2003-01-17
MAXIM ACCEL KNEE SYSTEM (K023546)Biomet, Inc.2003-01-17
LESSER METATARSAL PHALANGEAL JOINT IMPLANT (K023531)Nexa Orthopedics, Inc.2003-01-17
HYDROFERA BACTERIOSTATIC WOUND DRESSING (K023138)Hydrofera, LLC2003-01-17
LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130 (K024220)Bio-Rad2003-01-17
MILLEX VV, GV, AND HV SYRINGE FILTER UNITS (K023892)Millipore Corp.2003-01-17
VITIQUE SYSTEM (K023649)Dmg USA, Inc.2003-01-17
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS (K030067)Ortho-Clinical Diagnostics2003-01-17
LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113 (K024232)Bio-Rad2003-01-17
CG-500 PMP PERSONAL MEDICAL PHONE SYSTEM (K023689)Card Guard Scientific Survival , Ltd.2003-01-17
NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE (K023528)Centerplus Orthopedics, Inc.2003-01-17
ULTRASOUND SCANNER, TYPE 2400 (K024236)B-K Medical A/S2003-01-17
BIPOLAR FORCEPS (K023813)Richard Wolf Medical Instruments Corp.2003-01-17
TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION CONTROLS (K030088)Biosite Incorporated2003-01-17
FLASH-LITE II LED DENTAL CURING LIGHT (K023748)Discus Dental, Inc.2003-01-17
SURESET 3.0 ML RESERVOIR, MODEL 24-103 (K024056)Applied Diabetes Research, Incorporated2003-01-17
RADIONICS VARILINK 2 (K023519)Radionics, A Division of Tyco Healthcare Group LP2003-01-16
SKINTACT (K024264)Leonhard Lang Co.2003-01-16
PRE-POWDERED LATEX SURGEON'S GLOVES (K023515)Sanrea Healthcare Private Limited2003-01-16
DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES WITH SKIN-CARE INGREDIENTS (VITAMIN A, VITAMIN B, OC-LIPOIC ACID, EUCAL (K023490)Wrp Asia Pacific Sdn. Bhd.2003-01-16
SKINTACT (K023920)Leonhard Lang GmbH2003-01-16
REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE (K023952)Nobel Biocare Uas, Inc.2003-01-16
ENCLOSE ANASTOMOSIS ASSIST DEVICE (K023682)Novare Surgical Systems, Inc.2003-01-16
STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D (K022976)Dade Behring, Inc.2003-01-16
GENZYME CONTRAST II HCG URINE/SERUM TEST (K023544)Genzyme Corp.2003-01-16
INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION) (K024200)Ge Medical Systems, Inc.2003-01-16
TEMPORARY CEMENT-DC010002 (K023727)GC America, Inc.2003-01-16
MAYBE?MOM MINI OVULATION MICROSCOPE (K013582)Maybe?Mom2003-01-16
KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR (K023356)Card Guard Scientific Survival , Ltd.2003-01-16
SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL (K024247)Leonhard Lang GmbH2003-01-16
RDH-2000 (K023213)Anodia Systems2003-01-16
MODIFICATION TO STANDARD HUMAN PLASMA (K023141)Dade Behring, Inc.2003-01-16
LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112 (K024222)Bio-Rad2003-01-15
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Every clearance here is in the API, with alerts when new ones post.