Atlas FDA

2007

2,987 FDA 510(k) clearances · Clearance year

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RecordFirmDate
XTRACT CATHETER SYSTEM (K071529)Lumen Biomedical, Inc.2007-08-10
RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X (K071520)Core Essence Orthopaedics, LLC2007-08-10
AIRLIFE NEBULIZER CAP (K072119)Cardinalhealth2007-08-10
STRYKER EXTERNAL FIXATION SYSTEM (K071628)Stryker Cmf2007-08-10
CODIAGNOSTIX (R) 5.72 (K071636)Ivs Solutions AG2007-08-09
MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM (K071873)Varian Medical Systems, Inc.2007-08-09
GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM (K063771)Arkray Factory USA, Inc.2007-08-09
HEALIX ANCHOR (K071481)Depuy Mitek, A Johnson & Johnson Company2007-08-09
ACUMED SMALL BONE LOCKING SYSTEM II (K071944)Acumed, LLC2007-08-09
BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, XBIA 900 (K071884)Jawon Medical Co., Ltd.2007-08-09
GC-ZIRCONIA (K071674)GC America, Inc.2007-08-09
PEEK KNOTLESS ANCHORS (K070389)Biomet Sports Medicine, Inc.2007-08-09
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM (K071563)Smith & Nephew, Inc.2007-08-08
MEDPOR ATTRACTOR IMPLANT (K071335)Porex Surgical, Inc.2007-08-08
RTX3370 (K071953)Rtx Healthcare A/S2007-08-08
BIPAP SYNCHRONY 2 VENTILATORY SUPPORT SYSTEM (K071509)Respironics Inc., Sleep & Home Respiratory Group2007-08-08
FB-100U SERIES DIGITAL BLOOD PRESSURE MONITOR (K070209)Fego Precision Industrial Co;, Ltd.2007-08-08
TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS (K063086)Thermo Electron OY2007-08-08
OSTEOGRAF/D-300 (K072052)Dentsply International, Inc.2007-08-08
LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM (K070341)Ldr Spine USA2007-08-08
DIGITAL PULSE OXIMETER, MODEL 7500FO (K071415)Nonin Medical, Inc.2007-08-08
CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML (K072037)Life-Shield Products, Inc.2007-08-08
DELTA SPINAL FUSION SYSTEM (K071857)Jemo Spine, LLC2007-08-08
HF JUNIOR HEMOFILTER (K071298)Minntech Corp.2007-08-08
SBI TITANIUM THREADED PIN (K071540)Small Bone Innovations, Inc.2007-08-08
N LATEX RF KIT (K071247)Dade Behring, Inc.2007-08-08
NUVASIVE HELIX ACP SYSTEM (K071329)Nuvasive, Inc.2007-08-08
MISSION OLYMPUS AU ISE CALIBRATORS (K071039)Diamond Diagnostics, Inc.2007-08-08
ARTHROCARE SYSTEM 12000 (K071709)Arthrocare Corp.2007-08-07
MASTER GUARD NITRILE BLUE POWDERED EXAMINATION GLOVES (K071207)High Momentum Sdn Bhd2007-08-07
QUANTUM DIREX SYSTEM (K072010)Quantum Medical Imaging, LLC2007-08-07
DASH (K071775)Ezsurgical2007-08-07
MODIFICATION TO: ARTHROCARE ARTHROWANDS (K071963)Arthrocare Corp.2007-08-07
SBI RHEAD PLATING SYSTEM (K071549)Small Bone Innovations, Inc.2007-08-07
KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601 (K070360)Kirwan Surgical Products, Inc.2007-08-07
ORTHOMEND SOFT TISSUE MATRIX (K071807)Tei Biosciences, Inc.2007-08-06
THROMBI-PASTE THROMBIN/GELATIN POWDER PASTE HEMOSTAT (K070938)Vascular Solutions, Inc.2007-08-06
BENZ-G 4X HIOXIFILCON D (K062854)Benz Research and Development Corp.2007-08-06
OSTEOGRAF/D-700 (K072056)Dentsply International, Inc.2007-08-06
HEMCON CHITOFLEX-SURGICAL DRESSING (K071519)Hemcon, Inc.2007-08-06
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K071685)Langfang Huilong Plastic Product Co., Ltd.2007-08-06
POLARIS BE RODS (K071377)Biomet Spine2007-08-06
MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM (K071505)Integra LifeSciences Corporation2007-08-06
EKOS MICRO-INFUSION SYSTEM (K063620)Ekos Corp.2007-08-06
NUVASIVE OCT SYSTEM (K071435)Nuvasive, Inc.2007-08-06
LULLABY (K071828)Ge Healthcare Clinical Systems2007-08-06
QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIAL (K071989)Surgical Specialties Corp2007-08-06
SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC (K070117)Dolomite Biotech Sdn Bhd2007-08-06
OSTEOGRAF/LD-300 (K072057)Dentsply International, Inc.2007-08-06
DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A (K071767)Dade Behring, Inc.2007-08-04
CONVERTIBLE I-SERIES POSITIONING AND TRANSFER CHAIR (K071793)Barton Medical Corp.2007-08-03
INION HEXALON BIODEGRADABLE ACL/PCL SCREW (K071464)Inion OY2007-08-03
NEUROPORT ELECTRODE (K070272)Cyberkinetics Neurotechnology Systems, Inc.2007-08-03
C-JAWS CERVICAL COMPRESSIVE MINI FRAME (K072040)Medicrea Technologies2007-08-03
MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000 (K071341)Medivance, Inc.2007-08-03
SWABBABLE CAP, MODEL 60205 (K070163)Baxa Corp.2007-08-03
AXIS-V MONOCHROME 5 MP DISPLAY (K063066)National Display Systems2007-08-03
ADVIA CHEMISTRY ENZYMATIC CREATININE_2 (K070727)Siemens Medical Solutions Diagnostics2007-08-03
NOBELACTIVE INTERNAL CONNECTION IMPLANT (K071370)Nobel Biocare AB2007-08-03
MODIFICATION TO: OSTEOGRAF/N-700 (K072058)Dentsply Interntional2007-08-03
QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM (K072028)Surgical Specialties Corp2007-08-03
LLOYD LINDEN, MODEL E04 (K071761)Lloyd Linden, Inc.2007-08-03
UNIRING - ANNULOPLASTY RING WITH SIZERS (K071281)Peters Surgical2007-08-03
MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05 (K071960)Meditech Kft.2007-08-03
PXS-810, PODIATRY X-RAY SYSTEM (K071392)Source-Ray, Inc.2007-08-03
INTRINSIC THERAPEUTICS FIXATION STAPLE (K071637)Intrinsic Therapeutics Incorporated2007-08-03
MYLAB30, MODEL 7300 (K071996)Esaote, S.p.A.2007-08-03
MODIFICATION TO: ARTHREX INTERFERENCE SCREW (K071176)Arthrex, Inc.2007-08-03
ALLEVYN AG DRESSING (K063835)Smith & Nephew, Inc.2007-08-03
DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES (K071417)DePuy Orthopaedics, Inc.2007-08-02
HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE (K071785)Smiths Medical Asd, Inc.2007-08-02
SBI STAFIX (K071479)Small Bone Innovations, Inc.2007-08-02
SENTINEL LITHIUM ASSAY (K070987)SENTINEL CH. SpA2007-08-02
OPUS TWINLOCK KNOTLESS FIXATION DEVICE (K071374)Arthrocare Corp.2007-08-02
TRUEFIELD ANALYZER (K063310)Seeing Machines Limited2007-08-02
ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE (K071903)Vision-Sciences, Inc.2007-08-02
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200 (K071079)Gambro Bct, Inc.2007-08-02
BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES (K071043)Bausch & Lomb, Inc.2007-08-02
INSTRUMED RETRACTORS (K071771)Instrumed International, Inc.2007-08-02
TALON AND REVERE (K071245)Talon Acrylics, Inc.2007-08-02
BC (BODY COMPOSITION SOFTWARE) (K070999)Rjl Systems, Inc.2007-08-02
OPACIDEN SOLUTION (K070627)Ciden Technologies, LLC2007-08-02
PELVIMESH / HERMESH 7 (K070625)Marketing Solutions, Inc.2007-08-01
PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 (K070594)Pulmonetic Systems, Inc.2007-08-01
BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001 (K070201)C.R. Bard, Inc.2007-08-01
VICTORY, 4 WHEEL SCOOTER / MODEL, # SC1740 (K071949)Pride Mobility Products Corp.2007-08-01
SONICATOR PLUS 940, MODEL ME940 (K071137)Mettler Electronics Corp.2007-08-01
TATTOOSTAR Y (K071451)Asclepion Laser Technologies GmbH2007-08-01
ANGIODYNAMICS, INC.NEVERTOUCH 600UM FIBER AND VENACURE PROCEDURE KIT (K071959)AngioDynamics, Inc.2007-08-01
MODIFICATION TO: VIPER SPINE SYSTEM (K071860)Depuy Spine, Inc.2007-08-01
HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM (K071269)Smiths Medical Asd, Inc.2007-08-01
ARCHITECT TACROLIMUS: MODEL 1L77 (K070820)Fujirebio Diagnostics,Inc.2007-08-01
CERAMIC BALL HEADS, 28, 32 AND 36 MM (K070928)Plus Orthopedics AG2007-08-01
ABLE CENTRAL VENOUS CATHETER (K070451)Foshan Nanhai Bai HE Medical Technology Co., Ltd.2007-07-31
ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING (K071214)Genesee Biomedical, Inc.2007-07-31
ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552, 105043, 105041, 106553, 105039 (K071342)Possis Medical, Inc.2007-07-31
GRAFT CONTAINMENT DEVICE (K070148)Nuvasive, Inc.2007-07-31
PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEM (K070731)Plus Orthopedics AG2007-07-31
THERMA-CURE (K071590)Reliance Orthodontic Products, Inc.2007-07-31
SUBTALAR IMPLANT (K071498)Biomet Sports Medicine, Inc.2007-07-31
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Every clearance here is in the API, with alerts when new ones post.