Atlas FDA

2009

3,008 FDA 510(k) clearances · Clearance year

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RecordFirmDate
INTERPLATE C (K092070)Rsb Spine, LLC2009-10-06
BTI DENTAL IMPLANT TINY 2.5-3.0 (K092112)B.T.I. Biotechnology Institute, Sl.2009-10-06
OSSEOLINK DENTAL IMPLANT SYSTEM (K091878)Global Implant Solutions, LLC2009-10-06
FLEXICARE BREATHING FILTERS (K092218)Flexicare Medical, Ltd.2009-10-06
BEGO SEMADOS S-LINE (K090716)Bego Implant Systems GmbH & Co. KG2009-10-06
ADDPLUS (K090841)Ulrich GmbH & Co. KG2009-10-05
SUPER-FINE PEN NEEDLE (K092016)Stat Medical Devices, Inc.2009-10-02
ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204 (K092111)Entomed AB2009-10-02
SYNERGY CANNULATED SCREW SYSTEM (K092082)Synergy Surgical Technologies, LLC2009-10-02
AIA-PACK RBC FOLATE (K091332)Tosoh Bioscience, Inc.2009-10-02
DBX DEMINERALIZED BONE MATRIX PUTTY (K091217)Musculoskeletal Transplant Foundation2009-10-02
MEDLINE NITRILE EXAM GLOVES W/ALOE -GREEN (K090568)Medline Industries, Inc.2009-10-02
LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM (K092037)Hoana Medical, Inc.2009-10-02
CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23 (K091721)New Medical Technologies GmbH2009-10-02
STELLAR FIDUCIAL MARKER, MODEL GFMIA (K092041)Stellar Medical, LLC2009-10-02
BAXANO NEURO CHECK DEVICE (K092729)Baxano, Inc.2009-10-02
KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE (K090919)Kensey Nash Corp.2009-10-02
EOCENE SYSTEM (K090712)Infopia Co, Ltd.2009-10-02
LEFORTE SYSTEM BONE PLATE (K091679)Jeil Medical Corporation2009-10-02
MICROFUSE DUAL RATE INFUSER (K091386)Numia Medical Technology, LLC2009-10-02
MODEL SENTINELLA 102 (K092471)General Equipment For Medical Imaging, S.A.2009-10-02
SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM (K092058)Sonosite,Inc.2009-10-02
EASYCARE TX, TX LINK (K092026)Resmed, Ltd.2009-10-02
TSRH SPINAL SYSTEM (K092676)Medtronic Sofamor Danek, Inc.2009-10-02
EVISION DATA MANAGEMENT SOFTWARE (K092678)Nonin Medical, Inc.2009-10-01
CARTO RMT EP NAVIGATION SYSTEM V8 (K091789)Biosense Webster, Inc.2009-10-01
IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT (K092867)Kettenbach GmbH & Co. KG2009-10-01
GUARDIAN II HEMOSTASIS VALVE (K092711)Zerusa Limited2009-10-01
CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) (K092195)Cutera, Inc.2009-10-01
DYNESYS TOP-LOADING SPINAL SYSTEM (K092234)Zimmer Spine, Inc.2009-10-01
PICCOLO MAGNESIUM TEST SYSTEM (K091910)Abaxis, Inc.2009-10-01
SEAMFREE (K092539)Apex Dental Materials, Inc.2009-10-01
WATERLASE MD (K083927)Biolase Technology, Inc.2009-10-01
OPTOMED SMARTSCOPE, MODEL M3-1 EY1 (K092056)Optomed OY2009-10-01
PARCUS PPEK CF INTERFERENCE SCREW (K091093)Parcus Medical, LLC2009-09-30
INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250 (K092666)Boston Scientific Corp2009-09-30
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BF (K092161)Health & Life Co., Ltd.2009-09-30
CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE (K092003)MyCardio, LLC2009-09-30
PARCUS V-LOX PEEK CF SUTURE ANCHOR, MODELS: 10253, 10254, 10263, 10264 (K091094)Parcus Medical, LLC2009-09-30
POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200 (K091962)Lumenis, Inc.2009-09-30
PERIMETER INTERBODY FUSION DEVICE (K090353)Medtronic Sofamor Danek2009-09-29
CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 (K091637)Corpak Medsystems2009-09-29
SYNERGY (K083378)Innerspace, Inc.2009-09-29
GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4 (K092278)Gyrus Acmi, Inc.2009-09-29
JOURNEY BCS KNEE SYSTEM (K091014)Smith & Nephew, Inc.2009-09-29
HS AMICA (K083157)H.S Hospital Service S.P.A2009-09-29
MODEL GDCH-2000 (K092851)Global Dental Direct, Inc.2009-09-29
AADVA ZR COLORING LIQUID (K092020)GC America, Inc.2009-09-29
AUTOSAFE-REFLEX SAFETY HUBER INFUSION SET, AUTOSAFE ADVANTAGE SAFETY HUBER INFUSION SET (K090117)Autosafe-Reflex, Inc.2009-09-29
LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER (K091981)Lightmed Corp.2009-09-28
SHEATHESISO ULTRASOUND TRANSDUCER COVER (K091828)Sheathing Technologies, Inc.2009-09-28
ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M) (K091246)Trumpf Medizin Systeme GmbH + Co. KG2009-09-28
KAINOS+ (K090387)Signus Medizintechnik GmbH2009-09-28
GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM (K092756)Ge Vingmed Ultrasound AS2009-09-28
DBX DEMINERALIZED BONE MATRIX PUTTY (K091218)Musculoskeletal Transplant Foundation2009-09-28
SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015 (K091697)Transenterix, Inc.2009-09-28
IROOT BP PLUS (K092715)Innovative Bioceramix, Inc.2009-09-28
GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM (K090557)Given Imaging , Ltd.2009-09-28
ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT FOR NOBEL REPLACE IMPLANTS, ATLANTIS GEMINI + ABUTMENT FOR NOBEL (K091920)Astra Tech, Inc.2009-09-28
SPINEWAND SURGICAL DEVICE (K091228)Arthrocare Corp.2009-09-28
MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE (K083840)Msi Medserv International Deutschland GmbH2009-09-28
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-HIP (K091998)Mako Surgical Corp.2009-09-28
S8 ASPEN WITH H4I PLUS (K091947)Resmed, Ltd.2009-09-28
DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST (K091919)Sunrise Medical2009-09-28
SYNTHES LOCKING HAND PLATES (K092247)Synthes (Usa)2009-09-25
PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70 (K092012)Primed Medical Products, Inc.2009-09-25
SONOWAND INVITE (K083597)Sonowand AS2009-09-25
DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT (K091735)S & C Polymer GmbH2009-09-25
ELEGANT (K091826)3M Espe AG Dental Products2009-09-25
FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT (K091280)Maxx Orthopedics, Inc.2009-09-25
ELECYS ANTI-CCP CALCHECK (K091601)Roche Diagnostics Corp.2009-09-25
FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER (K091214)Footprint Medical2009-09-25
NOBELPROCERA ZI ABUTMENT (K091904)Nobel Biocare AB2009-09-25
KNEEALIGN SYSTEM (K091411)Orthalign, Inc.2009-09-25
SNM FIRMGRIP (K092629)Flexicath , Ltd.2009-09-25
OSOM INFLUENZA A&B TEST , MODEL PN190 (K092633)Genzyme Corporation2009-09-25
BIOMET MODULAR FEMORAL REVISION SYSTEM (K090757)Biomet, Inc.2009-09-25
SPI CUSTOMIZABLE GINGIVA FORMER (K092248)Thommen Medical AG2009-09-25
MODIFICATION TO: EXPEDIUM SPINE SYSTEM (K092626)Depuy Spine, Inc.2009-09-25
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K082648)Tangshan Dar Plastic & Rubber Products Co. , Ltd.2009-09-25
DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LD 1143 (K092683)Shanghai Little Doctor Co. Limited2009-09-25
ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35 (K083868)Axis-Shield Diagnostics, Ltd.2009-09-25
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K092415)Shijiazhuang Elegance Plastic Product2009-09-25
MANTIS REDUX SPINAL SYSTEM (K092631)Stryker Spine2009-09-25
HI-TORQUE PROGRESS GUIDE WIRE FAMILY (K091825)Abbott Vascular, Inc.2009-09-25
CONDUCTOR CORONARY GUIDEWIRE (K090193)Concert Medical, LLC2009-09-25
SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SCREW (K092646)Synthes (Usa)2009-09-25
FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN (K091213)Footprint Medical2009-09-25
SPINAL USA INTERBODY CAGES (K092193)Spinal USA2009-09-25
FIREBIRD SPINAL FIXATION SYSTEM (K092624)Blackstone Medical, Inc.2009-09-25
HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON (K090183)Cook Endoscopy2009-09-25
ALPHA DUO LAP INSUFFLATOR (K090652)Hippokratec GmbH2009-09-25
PASCAL STREAMLINE PHOTOCOAGULATOR (K092621)Topcon Medical Laser Systems, Inc.2009-09-25
VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX (K091946)Stryker Spine2009-09-25
NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000 (K090932)Nexgen Medical Systems, Inc.2009-09-24
PACSCAN PLUS, MODELS 300P AND 300AP (K092637)Sonomed, Inc.2009-09-24
XIO RTP SYSTEM (K092132)Computerized Medical Systems, Inc.2009-09-24
CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS (K091964)Procter & Gamble Co.2009-09-24
RP CUTTING NEEDLE (K092059)Riverpoint Medical2009-09-24
MODIFICATION TO BEACON STABILIZATION SYSTEM (K092610)Globus Medical, Inc.2009-09-24
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Every clearance here is in the API, with alerts when new ones post.