Atlas FDA

2005

3,156 FDA 510(k) clearances · Clearance year

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RecordFirmDate
OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES (K050681)TriMed, Inc.2005-07-27
DERMILLUME RED, MODEL HR1000 (K051681)Care Electronics, Inc.2005-07-27
DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR (K051393)Ever Global Enterprise Corporation2005-07-27
DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR (K050823)Teco Diagnostics2005-07-26
TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT (K051150)Scantibodies Laboratory, Inc.2005-07-26
NITRILE POWDERED EXAMINATION GLOVES (BLUE) (K051778)Hartalega Sdn Bhd2005-07-26
MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE (K051919)Usgi Medical2005-07-26
PLC SCREW (K051310)Smith & Nephew, Inc.2005-07-26
WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002 (K051141)Scantibodies Laboratory, Inc.2005-07-26
MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETER (K050542)Marian Medical, Inc.2005-07-26
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 4100 (K051790)3M Company2005-07-25
ELECSYS PRECICONTROL UNIVERSAL (K051687)Roche Diagnostics Corp.2005-07-25
BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER, MODELS 384647, 384667, 384687, 384648, 384668, 384688, 384649, 384669 (K051194)Becton, Dickinson & CO2005-07-25
SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE (K051720)Synthes (Usa)2005-07-25
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS (K051350)Dade Behring, Inc.2005-07-25
DYNATRON X3 , DYNATRON XP IR LIGHT PAD, D405 IR LIGHT PROBE (K051261)Dynatronics Corp.2005-07-25
ELEKTA ESARTE FRAME SYSTEM (K051746)Elekta Instrument AB2005-07-25
SAFETY NEEDLE (K051019)Sarstedt, Inc.2005-07-25
TOX A/B QUICK CHEK (K050891)Techlab, Inc.2005-07-25
SENTINEL PLASMAPROTEINS CAL 3X (K051457)Sentinel Ch. Srl2005-07-25
R2 BREAST IMAGING WORKSTATION (K051743)R2 Technology, Inc.2005-07-25
TERRAQUANT MQ2000 LASER THERAPY DEVICE (K043055)Escada International, Inc.2005-07-25
MILTEX RIGID STERILIZATION CONTAINER SYSTEM (K050570)Miltex, Inc.2005-07-25
3TP WORKSPACE (K050862)3tp, LLC2005-07-25
NITRILE EXAMINATION GLOVES, POWDER FREE (K051333)Shun Thai Rubber Gloves Industry Co., Ltd.2005-07-22
COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321 (K051365)K-Jump Health Co., Ltd.2005-07-22
ATLANTIS ABUTMENT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI+ ABUTMENT (K051652)Atlantis Components, Inc.2005-07-22
VINYL NITRILE CO-POLYMER POWDER FREE EXAM GLOVES (BLUE COLOR) (K051662)Grand Work Plastic Products Co., Ltd.2005-07-22
EQUA-PULL SAFETY RELEASE MODULE (K051751)Ortho Technology2005-07-22
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES (K051180)Vanguard Medical Concepts, Inc.2005-07-22
CERASORB DENTAL, CERASORB M DENTAL AND CERASORB PERIO (K051443)Curasan Ag, Frankfurt Facility2005-07-22
BIOPAD (K040283)Euroresearch Srl2005-07-22
ANEFIN, MODEL 100 (K033028)Axon Medical2005-07-22
AFINION HBALC (K050574)Axis-Shield Poc AS2005-07-22
VALLEYLAB G3000 ELECTROSURGICAL INSTRUMENT (K051627)Valleylab2005-07-22
ZIROX (K051249)Wieland Dental + Technik GmbH & Co. KG2005-07-22
CD HORIZON SPINAL SYSTEM (K051674)Medtronic Sofamor Danek USA, Inc.2005-07-21
TURBO-FLO PICC (K041849)Cook, Inc.2005-07-21
CELL-DYN SAPPHIRE SYSTEM (K051215)Abbott Laboratories2005-07-21
PROTEX CT CERVICOTHORACIC SPINAL SYSTEM (K050391)Globus Medical, Inc.2005-07-21
MIRAMATIC SAFE SYRINGE SYSTEM (K043322)Hager Worldwide, Inc.2005-07-21
FUTURE WASH/YPS (K051797)3M Espe AG Dental Products2005-07-21
AVANTICARE, MODEL SA4022 (K051538)Lerado China Limited2005-07-21
OSCAR, MODEL OE3000DB (K051053)Orthosonics, Ltd.2005-07-21
ACUMED RIB CONGRIENT BONE PLATE SYSTEM (K051410)Acumed, LLC2005-07-21
SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC (K051256)Noble Fiber Technologies, Inc.2005-07-21
REPROCESSED COLD BIOPSY FORCEPS (K042648)Sterilmed, Inc.2005-07-20
PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT (K051229)Smith & Nephew, Inc.2005-07-20
MODIFICATION TO SHOULDER FIXATION SYSTEM (K051728)Hand Innovations, LLC2005-07-20
INFINITY MONITORS WITH SCIO MODIFICATIONS (K051628)Draeger Medical Systems, Inc.2005-07-20
MEVIS LIVERANALYSER/LIVERVIEWER SOFTWARE (K051528)Mevis Technology GmbH & Co. KG2005-07-20
SCAN300FP / RETROPAN (VDC) (K051664)Oy Ajat, Ltd.2005-07-20
MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100 (K051837)Esaote, S.p.A.2005-07-20
REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION (K051523)Konica Minolta Medical & Graphic, Inc.2005-07-20
OSTEOVATION CMF BONE VOID FILLER (K051784)Skeletal Kinetics, LLC2005-07-20
REPROCESSED HOT BIOPSY FORCEPS (K050136)Sterilmed, Inc.2005-07-20
MARS HOLTER ANALYSIS WORKSTATION (K051026)Ge Medical Systems Information Technologies2005-07-19
PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML. (K051012)Salimetrics, LLC2005-07-19
MARROW PLUS (M+) (K051695)Berkeley Advanced Biomaterials, Inc.2005-07-19
EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM (K051682)Exactech, Inc.2005-07-19
SKYLIGHT LED CURING LIGHT (K051571)Dmetec.Co., Ltd.2005-07-19
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION (K051634)GE Healthcare2005-07-19
PERI-LOC LOCKING BONE PLATES AND LOCKING BONE SCREWS FOR THE UPPER EXTREMITY (K051735)Smith & Nephew, Inc.2005-07-19
DEALIGHT IPL (K043032)Europro, Inc.2005-07-19
MEDSTAR 220, MODEL 533-220; MEDSTAR 230, MODEL 533-230; MEDSTAR 360, MODEL 533-360; MEDSTAR 370, MODEL 533-370 (K050951)Cibernet Systems Corp.2005-07-19
SPIROTEL (K043528)Mir Medical Intl. Research Srl2005-07-19
ACUMEN IMAGE GUIDED SURGICAL SYSTEM (K051724)Ebi, L.P.2005-07-19
IMPRUV A.I. CREAM WOUND AND SKIN EMULSION (K041342)Stiefel Laboratories, Inc.2005-07-19
STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 UG OR LESS) (K051329)Siam Sempermed Corp., Ltd.2005-07-19
DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES (K050210)Biomet, Inc.2005-07-19
CALC-I-OSS (K042583)Ultradent Products, Inc.2005-07-19
HYDRALOK SYSTEM (K051216)Altiva Corp.2005-07-19
MODIFICATION TO V-40/C-TAPER ADAPTER SLEEVE (K051737)Howmedica Osteonics Corp.2005-07-19
ELITE IMPLANT (K050417)Zhermack S.P.A.2005-07-19
SECUR-FIT MAX AND PLUS MAX HIP STEMS (K051738)Howmedica Osteonics Corp.2005-07-19
NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT (K051599)Neurorecovery, Inc.2005-07-19
GENEROS SB SMALL BONE DISTRACTION IMPLANT (K051162)Orthonetx, Inc.2005-07-19
ANATOMICAL SHOULDER KEELED GLENOID (K051623)Zimmer GmbH2005-07-19
THERMAGE THERMACOOL COUPLING FLUID (K051710)Thermage, Inc.2005-07-19
VITESSE 2.0 (K051497)Varian Medical Systems, Inc.2005-07-18
L.E. DEMETRON II (K051545)Kerr Corporation (Danbury)2005-07-18
XELERIS 2 PROCESSING AND REVIEW WORKSTATION (K051673)GE Medical Systems2005-07-18
X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER (K051316)C.R. Bard, Inc.2005-07-18
CODMAN VPV SYSTEM, MODEL 82-3192 (K050739)Codman & Shurtleff, Inc.2005-07-18
EXTREME H2O 54% (HIOXIFILCON D) SOFT CONTACT LENS (SPHERICAL AND TORIC) (K051430)Hydrogel Vision Corporation2005-07-18
VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO (K051062)Flowcardia, Inc.2005-07-15
ECLIPSE BONDING AGENT (K051707)Dentsply Intl.2005-07-15
TSX-101A/H AQUILION 64 SP CT SCANNER; TSX-101A/I AQUILION 32 SP CT SCANNER (K051833)Toshiba America Medical Systems, In.C2005-07-15
DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES (K051635)GE Healthcare2005-07-15
ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE (K051381)Ace Surgical Supply Co., Inc.2005-07-15
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (WHITE, YELLOW) (K051723)Zibo Sinocare Plastic Products Co., Ltd.2005-07-15
THE ODFS DROPPED FOOT STIMULATOR (K050991)Department of Medical Physics and Biomedical Eng.2005-07-15
BIORESORB MACRO PORE (K050260)Oraltronics Dental Implant Technology GmbH2005-07-15
RES TRAXX DATA CENTER (K051314)Resmed, Ltd.2005-07-15
VERTEBROPLASTIC RADIOPAQUE BONE CEMENT (K043406)Depuy Spine, Inc.2005-07-15
LNOP BLUE OXIMETRY SENSOR (K051439)Masimo Corporation2005-07-15
MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM) (K051253)Baxter Healthcare Corp2005-07-15
AMSINO ENDOTRACHEAL TUBE (K050785)Amsino International, Inc.2005-07-15
HYDROGUM 5 (K051424)Zhermack S.P.A.2005-07-15
QD KNEE/FOOT COIL, MODEL MJQJ-147A (K051763)Toshiba America Medical Systems, In.C2005-07-14
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Every clearance here is in the API, with alerts when new ones post.