Atlas FDA

2004

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

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

RecordFirmDate
ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID (K040282)Internacional Farmaceutica, S.A. DE C.V.2004-04-29
VERSABOND AB BONE CEMENT (K022688)Smith & Nephew, Inc.2004-04-29
QUICKVUE ADVANCE PH AND AMINES GLL TEST (K040008)Quidel Corp.2004-04-29
MS-30 FEMORAL STEM STANDARD AND LATERAL (K040803)Zimmer, Inc.2004-04-29
HEMOSONIC 200HEMODYNAMIC MONITOR (K040802)Arrow Intl., Inc.2004-04-28
ELEMENTS OBTURATION UNIT (K031664)Sybron Endo/Analytic2004-04-28
K-Y BRAND WARMING ULTRAGEL PERSONAL LUBRICANT (K040340)Personal Products Company, Div. of Mcneil-Ppc, Inc.2004-04-28
TRIPTER X-1 COMPACT (K040470)Direx Systems Corp.2004-04-28
PARAMOUNT MINI GPS BILIARY STENT SYSTEM (K040653)Ev3, Inc.2004-04-28
NORMAL AND HYPERGAMMA CONTROL SERUM (K040925)Sebia2004-04-28
MINI L.E.D. OEM MODULE (K040808)Satelec2004-04-28
RITA SYSTEMS (K040989)Rita Medical Systems2004-04-28
ENDOMAT LC PUMP, MODEL 20 3303 20 (K031457)KARL STORZ Endoscopy-America, Inc.2004-04-28
NOBEL BIOCARE PERMANENT CENTRIC POST, MODELS 31234, 31235, 31236 (K040573)Nobel Biocare Uas, Inc.2004-04-28
PROTOS SOFTWARE (K040709)Aktina Medical Physics Corp.2004-04-28
COLOR CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM (K040365)Barco N.V.2004-04-28
MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 (K040880)Medical Analysis Systems, Inc.2004-04-28
.DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR (K040804)Southeastern Radiation Products, Inc.2004-04-28
CONCERTO BIPOLAR NEEDLE ELECTRODE (K040785)Boston Scientific Corp2004-04-28
DERMAGRIP-G, AND MULTIPLE CUSTOMERS TRADE NAME GREEN, ALOE VERA COATED, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEI (K040645)Wrp Asia Pacific Sdn. Bhd.2004-04-28
CALCIGEN -NAP BONE VOID FILLER (K033611)Biomet, Inc.2004-04-27
PORTACLAMP (K033085)Cardio Life Research, S.A.2004-04-27
HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS) (K040440)Http Hypothermia Therapy2004-04-27
PROTEGRITY STEILE LATEX SURGICAL GLOVES WITH COATING (K033905)Cardinalhealth2004-04-27
NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING (K033171)Northern Implants, LLC2004-04-27
CLIRPATH EXCIMER LASER CATHETER (K040067)Spectranetics Corp.2004-04-27
AQUADEX SYSTEM 100, MODEL A1100 (K040489)Chf Solutions, Inc.2004-04-27
STRYKER T4 HYTREL ZIPPER TOGA (K040764)Stryker Corp.2004-04-27
CAUTION CONDOMS (K033163)Richard Van Haussen America, Inc.2004-04-27
BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLE (K040054)Theodore Barash2004-04-27
RENACLEAN SH DIALYZER CLEANING SYSTEM (K033505)Minntech Corp.2004-04-27
SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000 (K040632)Smiths Medical Asd, Inc.2004-04-27
SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE (K040702)Grand Work Plastic Products Co., Ltd.2004-04-27
MODEL GST-1 (K040193)Medical Equipment Device Specialists2004-04-27
OSTEOGEN SBRG (K033098)Impladent , Ltd.2004-04-27
DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOM (K040185)Ssl Americas2004-04-27
VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE (K040984)Vision-Sciences, Inc.2004-04-27
IMAGE-ARENA AND RESEARCH-ARENA APPLICATIONS (K040546)Tomtec Imaging Systems GmbH2004-04-27
MULTIBLAST MEDIUM (K034063)Irvine Scientific Sales Co., Inc.2004-04-26
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES (K040846)Trek Diagnostic Systems, Inc.2004-04-26
NARKOMED 6400, MODEL NM6400 (K033498)Draeger Medical, Inc.2004-04-26
KETOCHECKS (K033114)Neo Diagnostics, Inc.2004-04-26
SERVO GUARD, MODEL 64 81 290 EH88E (K030071)Maquet, Inc.2004-04-26
DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100 (K040605)Dymedix, Inc.2004-04-26
SURGICAL FACE MASK - COLORS: WHITE, YELLOW, PINK, BLUE, AND GREEN (K022256)Tucker & Associates2004-04-26
VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME (CC0/SVO2/CEDV) MONITOR (K040287)Edwards Lifesciences, LLC2004-04-26
PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY (K020700)Pegasus Research Corp.2004-04-26
5M MEDICAL FLAT PANEL DISPLAY, ME511L (K031661)Totoku Electric Co., Ltd.2004-04-23
LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM (K040884)Hologic, Inc.2004-04-23
COALESCENT SURGICAL U-CLIP AND ACCESSORIES (K040821)Coalescent Surgical2004-04-23
AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR (K033860)Wako Chemicals USA, Inc.2004-04-23
TEM 3000 HEAD COIL (K040937)Mr Instruments, Inc.2004-04-23
PREVIEW TREATMENT PLANNING SOFTWARE (K040852)Medical Media Systems, Inc.2004-04-23
CRYO 5 (K040727)Zimmer Elektromedizin GmbH2004-04-23
MODIFICATION TO OUTBACK CATHETER (K040771)Lumend, Inc.2004-04-23
CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO (K040468)Cedara Software Corp.2004-04-23
COMPUMEDICS SUMMIT IP (K040194)Compumedics USA, Ltd.2004-04-23
DICOM THEATER (K033153)Ferguson Medical2004-04-23
LIFEPAK 12 (K040775)Medtronic Physio-Control Corp.2004-04-23
MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM (K040743)Datex-Ohmeda, Inc.2004-04-22
NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-405 (K040495)Naimco, Inc.2004-04-22
VANGUARD PATELLA COMPONENTS (K040770)Biomet Manufacturing, Inc.2004-04-22
ACCU-CHEK GO SYSTEM (K040796)Roche Diagnostics Corp.2004-04-22
NMX-1000 (K040584)Neomedix Corp.2004-04-22
SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09 (K032981)Invamed Technologies, Inc.2004-04-22
GC INITIAL MC, AL AND LF (K040567)GC America, Inc.2004-04-22
VITALSENSE (K033534)Mini-Mitter Co., Inc.2004-04-22
NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY (K033727)Nichols Institute Diagnostics2004-04-22
OTTER SAFETY SYRINGE (K040545)Otter (China) Technology Co., Ltd.2004-04-22
PRODOSE AAD SYSTEM (K030747)Profile Therapeutics Plc2004-04-22
ULTRASONIC SCALER ELEGANCE MS-10 (25K) (K040396)Rolence Enteprise, Inc.2004-04-22
MASIMO SET INTELLIVUE PULSE OXIMETER MODULE (K040259)Masimo Corp.2004-04-22
MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES (K040607)Pt. Medisafe Technologies2004-04-22
LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE, MODELS 08587, 08588, 08586 (K033699)Zest Anchors, Inc.2004-04-22
RESOLUTION HEMOSTASIS CLIPPING DEVICE (K040148)Boston Scientific Corp2004-04-22
AMS APOGEE VAULT SUSPENSION SYSTEM (K040537)American Medical Systems, Inc.2004-04-22
OXYGEN DIVERTER VALVE (K033914)Resmed, Ltd.2004-04-22
INFANT INCUBATOR, MODEL CHS-I1000 (K040910)Choong Wae Medical Corp.2004-04-21
HITACHI PRESTO (K040902)Hitachi Medical Systems America, Inc.2004-04-21
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K034056)Medtronic Sofamor Danek2004-04-21
MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK (K033630)Rhein 83 Srl2004-04-21
UNIPORT SELF-CONTAINED PORTABLE DENTAL UNIT (K040117)Arrow Industries, LLC2004-04-21
THE GNATHOMETER (K033092)Ortho Gnathics, LLC2004-04-21
SONO TT ULTRASONIC FLOWCOMPUTER (K040909)Em-Tec GmbH2004-04-20
STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE (K033123)Carl Zeiss Meditec, Inc.2004-04-20
PULPDENT VLC RESIN CEMENT (K040236)Pulpdent Corporation2004-04-20
LICOX PMO BRAIN MONITORING SYSTEM (K040235)Integra LifeSciences Corporation2004-04-20
HAWK INTRAORAL CAMERA AND ACCESSORIES (K040116)Dxm Co., Ltd.2004-04-20
PERSONAL WARMING LUBRICANT (K040085)Qualis, Inc.2004-04-20
ENDOSCOUT (K033485)Robin Medical, Inc.2004-04-20
MIVD 1218 18 INCH GREYSCALE LCD DISPLAY MODULE (K033006)Barco NV Barcoview2004-04-20
COOLTOUCH; COOLTOUCH II; AND COOLTOUCH CT3 ND:YAG LASER SYSTEM (K040131)New Star Lasers, Inc.2004-04-20
BICARD MIXING SYSTEM (K030366)Dialysis Systems, Inc.2004-04-19
ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC) (K040327)Accu-Stat Diagnostics, Inc.2004-04-19
VIATRONIX V3D COLON, REVISION 1.3 (K040126)Viatronix, Inc.2004-04-19
DISPOSABLE POWDERED VINYL PATIENT EXAMINATION GLOVES (K040828)Zibo Borui Plastic & Rubber Products Co., Ltd.2004-04-19
ANGIODYNAMICS, INC. MORE-FLOW HEMODIALYSIS CATHETER AND PROCEDURE KIT (K040402)AngioDynamics, Inc.2004-04-19
BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM (K040940)Olympus Corporation2004-04-19
VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING (K040786)Neometrics, Inc.2004-04-19
MGD 2621P MEDICAL GREYSCALE DISPLAY (K033104)Barco NV Barcoview2004-04-19
← Previous Next →

Track 2004 automatically

Every clearance here is in the API, with alerts when new ones post.