Atlas FDA

2011

3,124 FDA 510(k) clearances · Clearance year

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RecordFirmDate
CONCISE, SILICONE HYDROGEL DAILY WEAR SOFT CONTACT LENS (EFROFILCON A) (K111267)Abbconcise Optical Group, LLC2011-11-08
FIR HEAT THERAPHY SYSYEMS (K111273)Shenzhen Anpan Technology Co., Ltd.2011-11-08
PROW FUSION (K112359)Nlt Spine, Ltd.2011-11-08
FIBER DISK AND BLOCK (K112186)Bioloren S.R.L.2011-11-08
HI-TORQUE POWERTURN (K112957)Abbott Vascular-Cardiac Therapies2011-11-08
ACKERMANN EUROPCLIP (K111930)Ackermann Instrumente GmbH2011-11-08
CALIX PC SPINAL IMPLANT SYSTEM (K112036)X-Spine Systems, Inc.2011-11-08
ENTERAL FEEDING BAG AND SETS (K102741)Shandong Weigao Group Medical Polymer Co., Ltd.2011-11-08
SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES (K111615)Trek Diagnostic Systems2011-11-08
FM20 (K110612)Mediana Co., Ltd.2011-11-08
TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC (K111692)Somatex Medical Technologies GmbH2011-11-08
SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM) (K113129)Heidelberg Engineering GmbH2011-11-08
IT/IF CONTROL (K101863)Sebia2011-11-07
LAMINAR FLOW PHACO TIPS (K111882)Abbott Medical Optics, Inc.2011-11-07
MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS33I2 (K112145)Totoku Electric Co., Ltd.2011-11-07
SYNTHES ZERO-P VARIABLE ANGLE (VA) (K112068)Synthes Spine Co.Lp2011-11-07
S6 DIAGNOSTIC ULTRASOUND SYSTEM (K112602)Sonoscape Company Limited2011-11-07
NUFACE PLUS (K103472)Carol Cole Company2011-11-07
IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400 (K100811)ImpediMed Limited2011-11-04
INTERDRY SILVER (K110715)Milliken Healthcare Products, LLC2011-11-04
LIFTKAR PT (K111858)Sano Transportgeraete GmbH2011-11-04
ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS (K112603)Beckman Coulter, Inc.2011-11-04
ASCENSION NUGRIP CMC IMPLANT (K112278)Ascension Orthopedic2011-11-04
DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE (K112142)Siemens Healthcare Diagnostics2011-11-04
FXA (TM) (K110765)Aces GmbH2011-11-04
SIMPLYGO PORTABLE OXYGEN CONCENTRATOR (K111885)Respironics, Inc.2011-11-04
WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE) (K111392)Woojeon Company2011-11-04
TRIMED CLAVICLE FIXATION SYSTEM (K112509)TriMed, Inc.2011-11-04
ORTHO-JET CRYSTAL (K112397)Lang Dental Mfg. Co., Inc.2011-11-04
M VISUM ALERT ALARM MANAGEMENT SYSTEM (K112282)Mvisum, Inc.2011-11-04
PERFSCAPE V2.0 (K111161)Olea Medical2011-11-04
BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE (K103291)BioHorizons Implant Systems, Inc.2011-11-04
POLY-CHEM 90 ISE MODULE (K112408)Polymedco, Inc.2011-11-04
ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM (K103021)Infopia Co, Ltd.2011-11-04
MILESTONE KNEE SYSTEM, FEMORAL COMPONENT, POSTERIOR STABLIZED, UNOCATED / RLP, UNCOATED; TIBIAL INSERT / BASEPLATE... (K112285)Tgm Medical, Inc.2011-11-04
MEDISIZE RED AND MEDISIZE BLUE (K110246)Qserve America, Inc.2011-11-04
SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE (K111923)Pt. Intan Hevea Industry2011-11-04
OPTO MITRA YELLOW LASER (K111643)Opto Electronica SA2011-11-03
BIOHORIZONS ABUTMENTS FOR ZIMMER (K103691)BioHorizons Implant Systems, Inc.2011-11-03
BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR (K111648)Bracco Diagnostic, Inc.2011-11-03
AEQUALIS SHOULDER SYSTEM (K111902)Tornier2011-11-03
REPROBONE DENTAL GRAFTING MATERIAL (K103820)Ceramisys, Ltd.2011-11-03
HI TORQUE CONNECT GUIDEWIRE (K112381)Lake Region Medical2011-11-03
NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE (K110989)Neurovision Medical Products, Inc.2011-11-03
ENDOVASCULAR LASER VEIN SYSTEM KIT (K112299)Biolitec Medical Devices, Inc.2011-11-03
FUTURA (K102524)Dr. Oliver Wenker, M.D., M.B.A.2011-11-03
LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM (K103547)Lightmed Corp.2011-11-03
THERMO SCIENTIFIC MAS OMNI-CORE (K110738)Microgenics Corporation2011-11-03
ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM (K112945)Inrad, Inc.2011-11-03
BINGO PRO (K111474)Forum Engineering Technologies (96) , Ltd.2011-11-02
NANO SUTURE ANCHOR (K112965)Linvatec Corporation D/B/A Conmed Linvatec2011-11-02
SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930) (K112962)Spacelabs Medical, Inc.2011-11-02
REFLEX BALLON GUIDE CATHETER (K112262)Reverse Medical Corporation2011-11-02
U BY KOTEX CLICK UNSCENTED MENSTRUAL TAMPONS (K113036)Kimberly-Clark Corporation2011-11-02
MEDICAL MAGGOTS, LESOC (K102827)Monarch Labs, LLC2011-11-02
BIOCERAMIC ORBITAL IMPLANT, ORBTEX (K110554)Ceramisys, Ltd.2011-11-02
FOURSNARE VASCULAR RETRIEVAL SNARE (K112185)Cook, Inc.2011-11-02
DYNA-EXTOR II (K110426)Bk Meditech, Co., Ltd.2011-11-02
LEUCADIA(TM) MIS PEDICLE SCREW SYSTEM (K112931)Phygen, LLC2011-11-02
SEE CLEAR SOFT CONTACT LENS, SEE CLEAR COLOR SOFT CONTACT LENS, FIERCE SOFT CONTACT LENS (K111345)The See Clear Company, Inc.2011-11-02
VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI (K102378)Vectracor, Inc.2011-11-02
UC-CARE NAVIGO SYTEM (K100784)UC-CARE , Ltd.2011-11-01
BODY ANALYSIS SCALE (K112951)Shenzhen Healthcare Electronic Technology Co., Ltd.2011-11-01
LCI OPTION FOR INNOCOR (K102047)Innovision A/S2011-11-01
TRANSTEK (K112932)Zhongshan Transtek Electronics Co., Ltd.2011-11-01
EUS BALLOON (K111028)United States Endoscopy Group, Inc.2011-11-01
EYE-CEPT STERILE SALINE SOLUTION (K110221)Optics Laboratory, Inc.2011-11-01
COOLTOUCH (K103338)New Star Lasers, Inc.2011-11-01
DISTAL VOLAR RADIUS PLATING SYSTEMS (K112345)Medos International SARL2011-10-31
CLO-SURPLUS P.A.D. (K112961)Scion Cardio-Vascular, Inc.2011-10-31
FLIGHT 60 VENTILATOR (K111683)Flight Medical Innovations , Ltd.2011-10-31
BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS (K112107)Neurovirtual USA, Inc.2011-10-28
EASYSCAN MODEL 1.2 (K111988)I-Optics BV2011-10-28
ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION (K103278)I-Sens, Inc.2011-10-28
BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B (K112277)Becton, Dickinson and Company2011-10-28
MINI MASSEUSE (K110057)Mj Specialty Retail2011-10-28
NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS (K112259)Nobel Biocare AB2011-10-28
SOFRELINER TOUGH S (K112445)Tokuyama Dental Corporation2011-10-28
GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS (K110594)Nihon Kohden Corp.2011-10-28
CHX=CHX PLUS (K112250)Inter-Med, Inc.2011-10-28
PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR (K111693)Philips Medical Systems2011-10-28
SUMO ACCESS AND TISSUE RESECTION SYSTEM (K103155)Apollo Endosurgery, Inc.2011-10-28
DUOCENTRIC REVERSED (K103251)Aston Medical2011-10-28
TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM (K111723)Ev3, Inc.2011-10-27
VSI GUIDEWIRE (K112631)Vascular Solutions, Inc.2011-10-27
FIXATE TISSUE BAND (K112849)Anulex Technologies, Inc.2011-10-27
ALCATRON AND / OR MULTIPLE BRAND (K112222)Alcatron Gloves Factory2011-10-27
JMS APHERESIS NEEDLE SET WINGEATER(R) V2 (K112178)JMS North America Corporation2011-10-27
REHASTIM 2, REHAMOVE 2 (K112844)Hasomed GmbH2011-10-27
FETAL DOPPLER (K112911)Beijing Choice Electronic Technololgy Co., Ltd.2011-10-27
INVIZIA ANTERIOR CERVICAL PLATE SYSTEM (K111796)Zimmer Spine, Inc.2011-10-27
ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID (K112917)Medtronic, Inc.2011-10-27
SPIDERFX EMBOLIC PROTECTION DEVICE (K111010)Ev3, Inc.2011-10-27
4MP COLOR LCD MONITOR, RADIFORCERX430 (K112466)Eizo Nanao Corporation2011-10-27
NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS (K112713)Norfolk Medical Products, Inc.2011-10-27
MAHE PERFECT SPINE- PEDICLE SCREW SYSTEM (K110655)Mahe Medical GmbH2011-10-27
DX-D 600 (K112670)Agfa Healthcare N.V.2011-10-27
AESCULAP- MEITHKE SHUNT SYSTEM (K110206)Aesculap, Inc.2011-10-27
OSRAM ITOS (K110326)Osram Sylvania, Inc.2011-10-27
GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L (K111434)Giotto USA, LLC2011-10-27
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Every clearance here is in the API, with alerts when new ones post.