Atlas FDA

2004

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

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RecordFirmDate
STRUCTUR 2 SC (K040769)Voco GmbH2004-04-07
LIFESTYLE CIRCULATORY ENHANCER (K040084)Advanced Circulatory Systems, Inc.2004-04-07
HRV TOOLS (K040313)Del Mar Reynolds Medical, Ltd.2004-04-06
COOK URETERAL BALLOON DILATION CATHETER SET (K040127)Cook Urological, Inc.2004-04-06
CADIMPLANT (K040224)Praxim, Inc.2004-04-06
HEMOCLEAN (K023064)Krd Co., Ltd.2004-04-06
K-Y BRAND WARMING JELLY PERSONAL LUBRICANT (K040164)Personal Products Company, Div. of Mcneil-Ppc, Inc.2004-04-05
PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM (K040772)Penner Manufacturing, Inc.2004-04-05
LOVELY SYSTEM (K033946)Msq (M2) , Ltd.2004-04-05
CUSTODIOL (K032794)Dr. Franz Kohler Chemie GmbH2004-04-05
REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826 (K032139)Corgenix, Inc.2004-04-05
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM (K040111)Zeus Scientific, Inc.2004-04-05
SAFETYNET GUIDEWIRE INTRODUCER (K040029)Injectimed, Inc.2004-04-05
DELIGHT DENTAL ER: YAG LASER SYSTEM (K032797)Hoya Photonics, Inc.2004-04-05
EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187 (K032845)The First Years, Inc.2004-04-05
DYNATRAC, COD. 50-1A (K034051)3D Line USA, Inc.2004-04-05
MESACUP TEST PR-3 (K040711)Rhigene, Inc.2004-04-02
NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL) (K040352)Bioresource Technology, Inc.2004-04-02
THE CARDIOP-B SYSTEM (K030139)Paieon, Inc.2004-04-02
CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A (K032951)Chrono-Log Corp.2004-04-02
MSI MODEL S-500 RF GENERATOR (K033888)Medsphere International, Inc.2004-04-02
WELL@HOME SYSTEM (K040012)Zoe Medical, Inc.2004-04-02
BRITESMILE MASKING CREAM (K040797)Britesmile, Inc.2004-04-02
OSTEOSET DBM PELLETS, MODEL 8600-48XX (K022828)Wrightmedicaltechnologyinc2004-04-02
LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM (K040234)Photo Medex, Inc.2004-04-02
RESMED HOSPITAL NASAL MASK (K040566)Resmed, Ltd.2004-04-02
IDEAL 1 ORTHODONTIC BAND CEMENT (K040375)Dentsply Intl.2004-04-02
MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE (K040742)Advanced Sterilization Products2004-04-02
EAGLE ANTERIOR CERVIAL PLATE SYSTEM (K040197)Depuyacromed2004-04-02
BIRDSONG LEVERHALER, MODEL LH-1000 (K031982)Birdsong Medical Devices, Inc.2004-04-02
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (0.5-32 UG/ML) (K031601)Dade Behring, Inc.2004-04-02
SOMATOM SENSATION 64 AND SENSATION CARDIAC (K040665)Siemens Medical Solutions USA, Inc.2004-04-02
TRUST (K040718)Dhd Healthcare Corp.2004-04-02
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER (K033875)Cook, Inc.2004-04-02
GENZYME OSOM TRICHOMONAS RAPID TEST (K033864)Genzyme Corp.2004-04-02
CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF (K040264)Roche Diagnostics Corp.2004-04-02
SYNTHES AFS (K032534)Synthes Spine2004-04-01
QUIXX POSTERIOR RESTORATIVE (K040144)Dentsply International2004-04-01
NASOGASTRIC BRIDLE SYSTEM WITH MAGNETIC RETRIEVAL (K030784)Applied Medical Technology, Inc.2004-04-01
PALOMAR LUXV HANDPIECE (K040081)Palomar Medical Technologies, Inc.2004-04-01
NUVASIVE NEUROVISION JJB SYSTEM (K040543)Nuvasive, Inc.2004-04-01
MODIFICATION TO ACCULEAF (K040553)Direx Systems Corp.2004-04-01
RABBIT (K040087)Scion International, Inc.2004-04-01
ULTRAPRO MESH (K033337)ETHICON, Inc.2004-04-01
X-VIEW (K024186)Sometech Corporation2004-04-01
OSTEOSORB TACK FIXATION SYSTEM (K030989)Noviace Corporation2004-04-01
KYPHX HV-R, MODEL C01A (K033801)Kyphon, Inc.2004-04-01
MEDISIL SILICONE SHEETING (K040042)Medisil Corporation2004-04-01
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM (K040369)Stryker Instruments2004-04-01
LUCENTLITE, MODEL IMD 010 (K033072)Industrial & Medical Design, Inc.2004-04-01
CLICK-ON (K040633)Unomedical A/S2004-04-01
STRYKER RF ELECTRODES AND CANNULAE (K032406)Stryker Instruments2004-04-01
STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230) (K040240)Stellartech Research Corp.2004-04-01
STRYKER INTERVENTIONAL PAIN RF GENERATOR (K032601)Valley Forge Scientific Corp.2004-04-01
BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM (K033702)Blackstone Medical, Inc.2004-03-31
MANUAL WHEELCHAIR SERIES (K040561)Shanghai Wheelchair Factory2004-03-31
MODIFICATION TO: CD HORIZON SPINAL SYSTEM (K040583)Medtronic Sofamor Danek2004-03-31
MERLIN SPINE SYSTEM (K033901)Depuy Spine, Inc.2004-03-31
CORLINK AUTOMATED ANASTOMOTIC SYSTEM (K033979)By-Pass Makafim , Ltd.2004-03-31
ONEUSE- PLUS MICROKERATOME (K040297)Moria SA2004-03-31
BIOCRYL RAPIDE INTERFERENCE SCREW (K032717)Mitek Worldwide2004-03-31
ULTRASOUND IMAGING SYSTEM, MODEL 7300 (K040596)Esaote, S.p.A.2004-03-31
AESCULAP ABSORBABLE CRANIOFIX (K040080)Aesculap, Inc.2004-03-31
INION GTR BIODEGRADABLE MEMBRANE SYSTEM (K033074)Inion , Ltd.2004-03-31
OTOFLEX 100 TYE 1012 (K033645)Gn Otometrics A/S2004-03-31
SYNTHES EXTERNAL MIDFACE DISTRACTOR (K040083)Synthes (Usa)2004-03-31
HERCULON SOFT TISSUE REATTACHMENT SYSTEM (K040594)United States Surgical, A Division of Tyco Healthc2004-03-31
BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM (K040027)Boston Scientific2004-03-30
LIQUID OXYGEN SYSTEM (K032143)Micro Technology Services, Inc.2004-03-30
CARRARA INTERACTION CERAMIC SYSTEM (K040635)Dentsply Intl.2004-03-30
GEMINI SURGICAL LASER SYSTEM & ACCESSORIES (K034011)Laserscope2004-03-30
DUREX FLAVORED LATEX CONDOM (K032227)Ssl Americas, Inc.2004-03-29
MLT-1000 IR LASER SYSTEM (K033986)Medical Laser Therapeutics LP2004-03-29
JSA'S REPROCESSED COMPRESSION SLEEVE DEVICES (K040065)Jack Speer and Assoc., Inc.2004-03-29
QONTRAST (K040399)Amid2004-03-29
PROFILE 2000/3000 LASER SYSTEM (K040005)Sciton, Inc2004-03-29
NIO 5MP MEDICAL GRAYSCALE DISPLAY SYSTEM (K040040)Barco NV Barcoview2004-03-29
NIO 3MP MEDICAL GRAYSCALE DISPLAY SYSTEM (K040041)Barco NV Barcoview2004-03-29
THE ULTRA SYSTEM (K032445)Promedica, Inc.2004-03-29
LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMS (K040535)Cliniqa Corporation2004-03-29
LOW PROFILE LUTHER SAFETY HUBER (K040527)Luther Needlesafe Products, Inc.2004-03-26
ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM ACCESSORY (K040719)Aloka Co., Ltd.2004-03-26
ICON POLYAXIAL PEDICLE SCREW SYSTEM (K033090)Alphatec Mfg., Inc.2004-03-26
CHEETAH WHEELCHAIR (K033460)R82 A/S2004-03-26
UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR) (K032386)Impact Instrumentation, Inc.2004-03-26
PRIZM KERATOME BLADE, MODEL MK8512M2 (K033236)Surgin Surgical Instrumentation, Inc.2004-03-26
EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2 (K033050)Medtronic Vascular2004-03-26
CONTOUR SE MICROSPHERES (K034068)Boston Scientific Corp2004-03-26
MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS (K040128)Howmedica Osteonics Corp.2004-03-26
CERASORB M ORTHO (K040216)Curasan AG2004-03-26
ANTERIOR LUMBAR BUTTRESS SYSTEM (K040130)Seaspine2004-03-26
RETISCAN, RETIPORT (K023525)Roland Consult2004-03-26
ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT) (K031421)Nakanishi, Inc.2004-03-26
QUANTUM LIGHT THERAPY SYSTEM (K032816)Stargate International, Inc.2004-03-26
FIXION HIP SYSTEM (K032730)Disc-O-Tech Medical Technologies, Ltd.2004-03-26
CLEARFIL PHOTO CORE PLT (K033970)Kuraray Medical, Inc.2004-03-26
NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC (K034025)Nmt Medical, Inc.2004-03-26
VERTEBRON SCP CERVICAL PLATE SYSTEM (K040003)Vertebron, Inc.2004-03-26
POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS (K040568)Medtronic Vascular2004-03-25
LED TURBO (K040618)Apoza Enterprise Co., Ltd.2004-03-25
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Every clearance here is in the API, with alerts when new ones post.