Atlas FDA

2004

3,373 FDA 510(k) clearances · Clearance year

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RecordFirmDate
CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT (K033596)Exactech, Inc.2004-05-10
RANDOX METHADONE ASSAY (K040570)Randox Laboratories, Ltd.2004-05-10
MODIFICATION TO ADPER PROMPT (K040857)3M Espe AG Dental Products2004-05-10
ENVOY PATIENT MONITOR (K024245)Mennen Medical , Ltd.2004-05-10
COMPRESSION ANASTOMOSIS CLIP (CAC) (K033324)Niti Medical Technologies , Ltd.2004-05-10
AMYLASE LIQUID REAGENT, MODEL A532-200 (K040920)Teco Diagnostics2004-05-10
APAPORE BONE GRAFT SUBSTITUTE (K033722)Apatech , Ltd.2004-05-07
OMNI~NEB; OMNI~MAX (K030396)B&B Medical Technologies, Inc.2004-05-07
MEDLINE STRIDER MINI 4 (K040838)Medline Industries, Inc.2004-05-07
LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING (K033789)Cardinalhealth2004-05-07
NOVA GLUCOSE LOW/HIGH LEVEL CONTROL SOLUTIONS (K041016)Nova Biomedical Corp.2004-05-07
G-PGD (K033101)Vitrolife Sweden AB2004-05-07
G-OOCYTE (K032877)Vitrolife Sweden AB2004-05-07
FULL AUTO ARM DIGITAL BLOOD PRESSURE MONITOR (K032927)Sein Electronics Co., Ltd.2004-05-07
E-Z LUBRICATING JELLY (K041060)Chester Labs, Inc.2004-05-07
MEDLINE STRIDER MINI 3 (K040818)Medline Industries, Inc.2004-05-07
G-FREEZEKIT BLAST (K032154)Vitrolife AB2004-05-07
VIADUCT MINISCOPE AND ACCESSORIES (K040949)Acueity, Inc.2004-05-07
LAFACI (K032400)Vision Pro, LLC2004-05-07
OSTEO ACL SCREW MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T, (K032894)Linvatec Biomaterials, Inc.2004-05-07
PANALOK RC LOOP ANCHOR (K041065)Depuy Mitek2004-05-07
GENEX BONE GRAFT SUBSTITUTE (K040600)Biocomposites, Ltd.2004-05-07
G-THAWKIT BLAST (K032155)Vitrolife AB2004-05-07
IVC SYSTEM (K040317)Mark H. Friedman2004-05-07
USW NEEDLEKNIFE PAPILLOTOME (K040981)Wilson-Cook Medical, Inc.2004-05-07
SYNTHES (USA) 2.4 MM LCP WRIST PLATE (K040588)Synthes (Usa)2004-05-07
RICH-MAR AUTOPRISM INFRARED LAMP (K040679)Rich-Mar Corp.2004-05-07
BIOFILL BONE VOID FILLER (K040454)Scient'X2004-05-07
DEPUY PINNACLE ACETABULAR CUP SYSTEM, ESL MARATHON POLYETHYLENE LINERS, AND DEPUY ULTIMA UNIPOLAR FEMORAL HEADS (K033273)DePuy Orthopaedics, Inc.2004-05-06
D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS (K041061)Dideco S.P.A.2004-05-06
INTRA-AORTIC BALLOON (IAB) (K040801)Arrow Intl., Inc.2004-05-06
OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM (K040225)Osteoimplant Technology, Inc.2004-05-06
EASY CORE BIOPSY SYSTEM (K040893)Boston Scientific Corp2004-05-06
MODIFICATION TO SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP (K041099)Spsmedical Supply Corp.2004-05-06
NVISION DATA MANAGEMENT SOFTWARE (K033307)Nonin Medical, Inc.2004-05-06
NUMED MULLINS X PTA CATHETER (K041093)NuMED, Inc.2004-05-06
MODIFICATION TO CYCLONE ANTERIOR CERVICAL PLATE SYSTEM (K040397)Encore Medical L.P.2004-05-06
MODIFICATION TO VERTE-STACK SPINAL SYSTEM (K040536)Medtronic Sofamor Danek2004-05-05
STIMULONG PLUS CATHETER SET MODEL, VARIOUS (K033018)Pajunk GmbH2004-05-05
TRIATHLON CRUCIATE RETAINING (CR) TOTAL KNEE (K040267)Howmedica Osteonics Corp.2004-05-05
EFLOW ELECTRONIC INHALER/NEBULIZER (K033833)Pari Innovative Manufacturers, Inc.2004-05-05
INTUITIVE SURGICAL ENDOPASS ENDOSCOPIC DELIVERY INSTRUMENT, MODEL P/N 400170 (K040948)Intuitive Surgical, Inc.2004-05-05
LORENZ SELF-DRILLING IMF SCREW (K040983)Walter Lorenz Surgical, Inc.2004-05-05
DEPUY PRESERVATION UNICONDYLAR TIBIA (K040268)DePuy Orthopaedics, Inc.2004-05-05
GREENLIGHT 300 (K040410)A C Cossor & Son (Surgical) Limited2004-05-05
FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A (K040506)Fisher & Paykel Healthcare, Ltd.2004-05-05
RESCAN (K034033)Resmed, Ltd.2004-05-05
REMSTAR AUTO WITH C-FLEX CPAP SYSTEM (K041010)Respironics, Inc.2004-05-05
LASERPRO DIODE LASER SYSTEMS, MODELS 810, 940 & 980 (K040294)Photo Medex, Inc.2004-05-05
KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS (K040196)Tyco Healthcare/Kendall2004-05-05
DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR (K040069)Dymedix, Inc.2004-05-05
GORE TRI-LOBE BALLOON CATHETER (K033670)W. L. Gore & Associates, Inc.2004-05-05
DXL CALSCAN (K033550)Demetech AB2004-05-05
ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-ACC-1 (K040641)Epicor Medical, Inc.2004-05-05
ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE (K040629)Accu-Stat Diagnostics, Inc.2004-05-05
COOLAN 300 (K030810)Coolanalgesia , Ltd.2004-05-05
HEARTSTART MRX, MODEL M3535A (K040404)Philips Medical Systems, Inc.2004-05-04
BZ-576 NON-INVASIVE AUTOMATIC BLOOD PRESSURE MONITOR (K033216)The Buzz Group, LLC2004-05-04
SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE (K040376)Sectra-Imtec AB2004-05-04
ARTOSCAN C (K040877)Esaote, S.p.A.2004-05-04
INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM (K040146)Interlab S.R.L.2004-05-04
KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305 (K033189)King Systems Corp.2004-05-04
STRAUMANN GRANULES (K040646)The Straumann Co.2004-05-03
ACON OPI ONE STEP OPIATE TEST STRIP AND ACON OPI ONE STEP OPIATE TEST DEVICE (K040274)ACON Laboratories, Inc.2004-05-03
CERAFORM BONE VOID FILLER (K040669)Teknimed, S.A.2004-05-03
PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE (K040936)Leda Co., Ltd.2004-05-03
EOVIA CALCIUM PHOSPHATE CERAMIC (K040514)Ortho Tec, LLC2004-05-03
BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED (K041025)Golden Technologies, Inc.2004-05-03
FIBREX CATHETER PATENCY DEVICE (K040427)Medical Device Technologies, Inc.2004-05-03
RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER (K040856)Rapid Aid , Ltd.2004-05-03
TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS (K040312)Procter & Gamble Co.2004-05-03
HEMOSIL VON WILLEBRAND ACTIVITY (K040843)Instrumentation Laboratory CO2004-04-30
THE STRAUMANN ORTHO IMPLANT SYSTEM (K040469)The Straumann Co.2004-04-30
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES (K031687)Vanguard Medical Concepts, Inc.2004-04-30
PERFECT SAFETY SYRINGE (K030604)Perfect Medical Industry Co., Ltd.2004-04-30
QUANTUM CEMENT RESTRICTOR (K040276)Quantum Orthopedics2004-04-30
EASYTEM DUO, FOREHEAD/EAR THERMOMETER, MODEL BT-021 (K033077)Metatech Co., Ltd.2004-04-30
SENORX BIOPSY DEVICE II (K040842)Senorx, Inc.2004-04-30
MOBILE OXYGEN STORAGE TANK (MOST) (K040738)Pacific Consolidated Industries Llp2004-04-30
PANALOK LOOP ANCHOR (K040827)Depuy Mitek, A Johnson & Johnson Company2004-04-30
AXSYM CYCLOSPORINE (K040761)Abbott Laboratories, Inc.2004-04-30
MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP (K040899)Medex, Inc.2004-04-30
RIVA LUTING (K040393)Southern Dental Industries, Inc.2004-04-30
WU'S 4-WHEELED NEO SCOOTER, MODEL WT-T4D (K040968)Wu'S Tech Co., Ltd.2004-04-30
SONA PILLOW (K040161)Sleep Devices, Inc.2004-04-30
APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2 (K033198)Apoza Enterprise Co., Ltd.2004-04-30
PERIVAC KIT, MODELS 4304, 4305, 4314, 4315 (K040867)Boston Scientific Corp2004-04-30
SMARTLITE D FREQUENCY DOUBLED ND:YAG LASER (K040289)Cynosure, Inc.2004-04-30
KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING (K033453)Tyco Healthcare2004-04-29
MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH (K040998)Sofradim Production2004-04-29
INTERFERENTIAL STIMULATOR, MODEL BMLS03-6 (K040824)Biomedical Life Systems, Inc.2004-04-29
SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE (K040690)Cryocath Technologies, Inc.2004-04-29
MODIFICATION TO LTV 1000 VENTILATOR (K040540)Pulmonetic Systems, Inc.2004-04-29
BP CUFF BARRIER 1081789, BP CUFF BARRIER, PLASTIC COATED 1030193 (K032568)Med Textile, LLC2004-04-29
MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905 (K040892)Nidek Medical Products, Inc.2004-04-29
MINRAY (K033755)Soredex Palodex Group OY2004-04-29
ATLANTIS SR, MODEL C4020; ATLANTIS SR PLUS, MODEL 35975 (K040776)Boston Scientific Corp2004-04-29
PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B (K040917)Philips Medizin Systeme Boeblingen GmbH2004-04-29
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM (K040833)Ebi, L.P.2004-04-29
MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122 (K040228)Medi-Stim A/S2004-04-29
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Every clearance here is in the API, with alerts when new ones post.