Atlas FDA

2002

3,685 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SULZER DENTAL CERAMIC SYSTEM-SPLINE (K014214)Sulzer Dental, Inc.2002-03-19
MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR (K020526)Don Wilson/Wilson-Cook Medical, Inc.2002-03-19
HEARTTRENDS (K012825)Lev-El, Ltd.2002-03-19
NELSON ELECTROSURGICAL UNIT, MODEL GN640 (K014172)Aesculap, Inc.2002-03-19
UNIVEC BIFURCATED SLIDING SHEATH SYRINGE (K020500)Univec, Inc.2002-03-19
KAYAK HYDROPHILIC GUIDE WIRES (K014195)Boston Scientific Corp2002-03-19
ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101 (K010253)Transonic Systems, Inc.2002-03-19
FORTAFLEX SURGICAL MESH (K020049)Organogenesis, Inc.2002-03-18
VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00 (K014154)Vilex, Inc.2002-03-18
CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR (K013201)Cardiofocus, Inc.2002-03-18
MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM (K020069)Medtronic Midas Rex2002-03-18
CONVERTORS SMS POLYOLEFIN GOWN (K020593)Allegiance Healthcare Corp.2002-03-18
CERASORB ORTHO (K014156)Curasan AG2002-03-18
PAEDISCOPE, MODEL # P010A AND PF011A (K014149)Aesculap, Inc.2002-03-18
OPENING/CLOSING WEDGE OSTETOMY PLATES (K014155)Arthrex, Inc.2002-03-18
PHILIPS INTEGRIS ALLURA 9 WITH FD OPTION (K020055)Philips Medical Systems2002-03-15
SIMIDUR S1S (K020195)Wieland Dental + Technik GmbH & Co. KG2002-03-15
MODIFICATION TO THE MAESTRO SYSTEM (K020645)BioHorizons Implant Systems, Inc.2002-03-15
BELLEGLASS HP MODELING GEL (K020178)Kerr Dental Materials Center2002-03-15
CLASSIC TENS (K020437)Care Rehab, Inc.2002-03-15
AUTODIMER ASSAY MODEL # 1431 (K012755)Xtrana, Inc.2002-03-15
SIMIDUR S2 (K020192)Wieland Dental + Technik GmbH & Co. KG2002-03-15
XIVE DENTAL IMPLANT SYSTEM (K013867)Friadent GmbH2002-03-15
ADVANCE UNICONDYLAR KNEE SYSTEM (K014171)Wrightmedicaltechnologyinc2002-03-15
SIMIDUR KF PLUS (K020194)Wieland Dental + Technik GmbH & Co. KG2002-03-15
NEW PROPHY POWDER (K014188)Dentsply Intl.2002-03-15
MODIFICATION TO SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX TV SYSTEM) (K020126)Surx, Inc.2002-03-15
ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY (K020217)Bayer Diagnostics Corp.2002-03-15
GAZELLE WHEELCHAIR (K020536)Alum Creek Wheelchair Co., Inc.2002-03-15
ENGUARD REMOTE PATIENT MONITOR (K020632)Mennen Medical , Ltd.2002-03-15
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE GENESIS KNEE SYSTEM, THE GENESIS II KNEE SYS (K012778)Smith & Nephew, Inc.2002-03-15
KARMA DISCOVERY, MODEL KP40 (K014127)Vestil Manufacturing Corp.2002-03-15
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE COFIELD TOTAL SHOULDER SYSTEM, THE NEER II (K012788)Smith & Nephew, Inc.2002-03-15
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE REFLECTION ACTABULAR SYSTEM (ACETABULAR LINE (K012787)Smith & Nephew, Inc.2002-03-15
COAPT SYSTMES ENDOTINE DEVICE (K014153)Coapt Systems, Inc.2002-03-15
STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM (K020097)Stryker Endoscopy2002-03-15
COMFORT WHEELCHAIRS (K020451)Comfort Orthopedic Co., Ltd.2002-03-14
EMS HEPA FILTER AND HME COMBINATIONS (K013089)Engineered Medical Systems2002-03-14
ENDOSCOPIC CAMERA MC404/C3 (K020336)World of Medicine Lemke GmbH2002-03-14
ENDOSCOPIC CAMERA TC804/C4 (K014158)World of Medicine Lemke GmbH2002-03-14
PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT (K014138)Pulpdent Corp.2002-03-14
IALUSET HYDROCOLLOID (K020041)Institut Biochimique SA (Ibsa)2002-03-14
EMS PULMONARY FUNCTION TESTING FILTER (K013123)Engineered Medical Systems2002-03-14
DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH PENICILLIN (K020162)Dade Behring, Inc.2002-03-14
MICROSCAN SYNERGIES PLUS (K020142)Dade Behring, Inc.2002-03-14
MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL (K012350)Porex Surgical, Inc.2002-03-14
CHASE CARDIOVASCULAR PATCH KIT (K020233)Chase Medical, Inc.2002-03-14
DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH AMPICILLIN (K020160)Dade Behring, Inc.2002-03-14
AMLUCK AUTOMATIC DIGITAL WRIST, BLOOD PRESSURE MONITOR AK-3000/AK-4000 (K012796)Amluck, Inc.2002-03-14
PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE (K014133)Pulpdent Corp.2002-03-14
VECTORVISION TRAUMA (K012448)Brainlab AG2002-03-14
MITEK BIOCRYL INTERFERENCE SCREWS (K013572)Mitek Products2002-03-14
SOPRO 367D 3CCD FULL DIGITAL ENDOSCOPY CAMERA (K020270)Sopro2002-03-14
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TRIMETHOPRIM/SULFAMETHOXAZOLE (0.25/4.75-64/1216 UG/ML) (K020248)Dade Behring, Inc.2002-03-14
OPIATES (K013314)Abbott Laboratories2002-03-13
PISCES PLUS (DW286 C) (K020183)Ivoclar Vivadent, Inc.2002-03-13
STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) (K014230)Supermax Glove Manufacturing Sdn Bhd2002-03-13
PLAYTEX DEODORANT TAMPONS, MODEL 34802 (K020200)Playtex Products, Inc.2002-03-13
AMPHETAMINE/METHAMPHETAMINE (K012998)Abbott Laboratories2002-03-13
CANNABINOIDS (K013247)Abbott Laboratories2002-03-13
MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM (K020446)American Medical Systems, Inc.2002-03-13
BENZODIAZEPINES (K013143)Abbott Laboratories2002-03-13
PORTADUR P 4 (K020190)Wieland Dental + Technik GmbH & Co. KG2002-03-13
COCAINE (K013004)Abbott Laboratories2002-03-13
PHENCYCLIDINE (K013096)Abbott Laboratories2002-03-13
MTP CLEARVISION DISPOSABLE TUBING SET (K020599)Mtp Medical Technical Promotion GmbH2002-03-13
NVA-63-8 NEUROVASCULAR ARRAY COIL (K020606)Mri Devices Corp.2002-03-13
QACA IGG/IGM ELISA KIT (K020241)Cheshire Diagnostics , Ltd.2002-03-13
IMPLANT GUIDANCE SYSTEM APPLICATOR SET (K020015)Nucletron Corp.2002-03-13
IMUBIND TPA ELISA, MODEL 860 (K013492)American Diagnostica, Inc.2002-03-13
AUTOMARQER (K012805)Hamilton Thorne Research2002-03-13
LIFESTYLE OXYGEN CONCENTRATOR (K020324)Airsep Corp.2002-03-13
ACIST 4 FRENCH ANGIOGRAPHIC CATHETER (K012983)Acist Medical Systems, Inc.2002-03-13
MODIFICATION TO MAGNETOM RHAPSODY SYSTEM (K020573)Siemens Medical Solutions USA, Inc.2002-03-13
HIGHGATE CURVED ROD SYSTEM (K012045)Highgate Orthopaedics2002-03-12
IN-TIME RETRIEVAL DEVICE (K014109)Boston Scientific, Target2002-03-12
PREFERNCE IMRT TREATMENT PLANNING MODULE (K012575)Northwest Medical Physics Equipment, Inc.2002-03-12
SONOPSY (K013109)Hakko Medical Co., Ltd.2002-03-12
RBM (K020480)Smith & Nephew, Inc.2002-03-12
PLAYTEX DEODORANT TAMPONS, MODEL 34702 (K020202)Playtex Products, Inc.2002-03-12
NUVASIVE TRIAD FACET SCREW SYSTEM (K020411)Nuvasive, Inc.2002-03-12
GREAT TOE IMPLANT SYSTEM (K014164)Harmos Orthopaedics, Inc.2002-03-12
WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA (K020544)Churchill Medical Systems, Inc.2002-03-12
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1 (K020725)Microlife Corp.2002-03-12
PLAYTEX DEODORANT TAMPONS, MODEL 34902 (K020201)Playtex Products, Inc.2002-03-12
ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML (K020485)Baxter Healthcare Corp2002-03-12
OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES (K012377)Corin USA2002-03-11
GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25 (K012869)Gimmi GmbH2002-03-11
VISTITOME 20-10 MICROKERATOME (K014000)Biovision AG2002-03-11
ENDIUS SPINAL FIXATION SYSTEM (K014090)Endius, Inc.2002-03-11
EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL (K014052)Edwards Lifesciences, LLC2002-03-08
STERN MICRO ERA ATTACHMENT SYSTEM (K020391)Sterngold2002-03-08
CONDUIT TCP GRANULES (K014053)Depuyacromed2002-03-08
SERRALENE, MODEL CATALOG NO 1S (K020265)Serral, S.A. DE C.V.2002-03-08
LP(A)-LATEX SEIKEN ASSAY KIT (K013359)Denka Seiken'S2002-03-08
MODIFICATION TO EBI XFIX DFS OPTIROM ELBOW FIXATOR (K020403)Ebi, L.P.2002-03-08
SANARUS VISICA TREATMENT SYSTEM (K020605)Sanarus Medical, Inc.2002-03-08
EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN 600-665 AND EN 600-670 MECHANICAL WHEELCHAIRS (K020094)Regulatory Insight, Inc.2002-03-08
BIOTECH MANUAL WHEELCHAIR, A1000 SUPER SPORT WHEELCHAIR (K020188)Taiwan Armada Enterprise Co., Ltd.2002-03-08
SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL WHEELCHAIRS (K020100)Regulatory Insight, Inc.2002-03-08
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Every clearance here is in the API, with alerts when new ones post.