Atlas FDA

2002

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

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RecordFirmDate
MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (K022270)Olympus Optical Co., Ltd.2002-08-14
DASH 3000/4000 PATIENT MONITOR (K020290)General Electric Medical Systems Information Techn2002-08-14
SYNTHES CRANIOFACIAL PLATES (K021642)Synthes (Usa)2002-08-14
ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS (K020984)Access Cardiosystems, Inc.2002-08-14
INTRAORAL MANDIBULAR DISTRACTION SYSTEM (K013618)Osteomed Corp.2002-08-14
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS (K012523)Sterilmed, Inc.2002-08-14
SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K021898)Cordis Corp.2002-08-14
WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER (K021808)Weck2002-08-14
SERRALGUT (K020597)Serral, S.A. DE C.V.2002-08-14
SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER, SINGLE STEP HOLDERS (K021707)Senorx, Inc.2002-08-14
GRIPPER PLUS NEEDLE (K021999)Deltec, Inc.2002-08-13
SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM (K022567)Acuson Corp.2002-08-13
ELECTROPHYSIOLOGY CATHETER (K012708)Alliance Medical Corp.2002-08-13
ULTRAGUIDE CTG 2000SA (K022354)Ultraguide , Ltd.2002-08-13
GLOVCO EBONY (K013828)Glovco (M) Sdn. Bhd.2002-08-13
ISA-21 INTERVENTIONAL SPINE ARRAY COIL (K021631)Mri Devices Corp.2002-08-13
DELTEC INSULIN INFUSION PUMP AND ACCESSORIES (K020655)Deltec, Inc.2002-08-13
MODIFICATION TO ISOLA SPINAL SYSTEM (K022285)Depuyacromed2002-08-13
SENSA-CUFF, MODELS INFANT, CHILD, ADULT (K022482)Ge Medical Systems Information Technologies2002-08-13
7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETIT (K020759)Hans Rudolph, Inc.2002-08-13
EMS PIEZON MASTER 600 (K022328)Electro Medical Systems SA2002-08-13
3D NAVIGATION INTERFACE FOR SIREMOBILE ISO-C 3D (K022337)Siemens Medical Solutions USA, Inc.2002-08-13
BRUNO ELECTRA-RIDE, MODEL SRE-2700 (K022509)Bruno Independent Living Aids, Inc.2002-08-13
MHS MED LIGHT 1000 (K021956)Micro Health Systems, Inc.2002-08-13
HRH-127-8 HEAD ARRAY COIL (K022372)Mri Devices Corp.2002-08-13
SPHERZ (K022074)I.Z.I. Corp.2002-08-13
96 CHANNEL EEG HEADBOX MODEL EMU96 (K021599)Excel Tech. , Ltd.2002-08-13
SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY (K022197)The Electrode Store, Inc.2002-08-13
CERALAS D DIODE LASER SYSTEM, MODEL # D50 (K013691)Biolitec, Inc.2002-08-13
PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION (K021573)Puritan-Bennett2002-08-13
1.5T SCANMED PV ARRAY (K022395)Medic, Inc.2002-08-13
MODIFICATION TO MEDSTATION (K021934)Aisoftw@Re Medical, S.P.A.2002-08-12
FULCRUM (K021949)Howtek, Inc.2002-08-12
HYDROBOOT (K022233)Incappe, Inc.2002-08-12
TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER (K021574)Card Guard Scientific Survival , Ltd.2002-08-12
NITRILE EXAMINATION GLOVES POWDERFREE (BLUE COLOR) (K021668)Innovative Gloves Co;, Ltd.2002-08-12
RAPID-FILL TUBESET, MODEL 90005 (K022523)Baxa Corp.2002-08-12
ALPHA INFUSION PUMP AND CATHETERS (K021964)Advanced Infusion, Inc.2002-08-12
PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR LESS) (K021659)P.T. Healthcare Glovindo2002-08-12
EBI DYNAFIX VS OSTEOTOMY SYSTEM (K021749)Ebi, L.P.2002-08-12
MULTIVISION METHAFILCON A SOFT (HYDROPILIC) MULTIFOCAL LENS FOR DAILY WEAR (K021720)Soflex Isralens Contact Lens , Ltd.2002-08-12
MAGLY 6.5MM CANNULATED SCREWS (K021662)Magly Orthopedics, LLC2002-08-12
MODIFICATION TO RELIEF BRIEF (K003128)The JM Kohn Co.2002-08-12
MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300 (K021902)Medtronic Vascular2002-08-12
MODIFICATION TO PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MIC (K022405)Rehabilicare, Inc.2002-08-12
TRANSONIC FLOW-QC SET MODEL ADT1010 (K021571)Transonic Systems, Inc.2002-08-12
HALLU PLATES (K021626)New Deal, S.A.2002-08-12
CADENCE CEMENT RESTRICTOR (K022218)Spinal Concepts, Inc.2002-08-12
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM (K022172)Becton, Dickinson & CO2002-08-12
PATXFER (K021583)Brainlab AG2002-08-12
HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES (K022546)Horizons Intl. Corp.2002-08-12
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM (K022419)Ebi, L.P.2002-08-12
UKNEE TOTAL KNEE SYSTEM (K021657)United Orthopedic Corp.2002-08-12
EBI XFIX DFS SYSTEM (K022319)Ebi, L.P.2002-08-12
SYDNEY IVF CULTURE OIL (K022002)Cook Urological, Inc.2002-08-12
DURACLEAN WITH LYCRA POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE (K022095)Wilshire Technologies2002-08-09
FLEXLINE CLAMP (K010727)Novare Surgical Systems, Inc.2002-08-09
SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW (K021556)Synthes (Usa)2002-08-09
NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE (K021578)Sulzer Orthopedics, Inc.2002-08-09
MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM (K021579)Magly Orthopedics, LLC2002-08-09
GIVEN DIAGNOSTICS SYSTEM (K022362)Given Imaging , Ltd.2002-08-09
LUMENIS SELECTA DUET (K021550)Ellex Medical Pty, Ltd.2002-08-09
ADAPT OPEN ACCESS PORT, MODEL 41233 (K021731)Taut, Inc.2002-08-08
BD PRESET BLOOD COLLECTION SYRINGE, BD A-LINE BLOOD COLLECTION SYRINGE, MODELS 365313, 365323,365316,365356,365373,36538 (K022426)Becton, Dickinson & CO2002-08-08
BOYD DELIVERY UNIT (K020833)Boyd Industries, Inc.2002-08-08
MULTIPLE LABELS, POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE (K022305)Heyuan Hongli Industries, Inc.2002-08-08
ACTIBAND (K022404)Paw, LLC2002-08-08
LAMITRODE S-SERIES (S4 AND S8) LEADS (K022222)Advanced Neuromodulation System,Inc2002-08-08
SHEATH ADAPTER, MODEL SA-09847 (K021723)Arrow Intl., Inc.2002-08-08
QUANTIM 16 AUTOCLAVE (K021064)Scican2002-08-08
CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 (K022107)Cardiomedics, Inc.2002-08-08
LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR (K021538)Lightmed Corp.2002-08-08
AART SILICONE SHEETING (K022223)Aesthetic and Reconstructive Technologies, Inc.2002-08-08
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION (K021143)Alcon Universal, Ltd.2002-08-08
URETERAL STENT (K013784)Boston Scientific Corp2002-08-08
BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER (K021735)Boston Scientific Scimed, Inc.2002-08-08
OSA RIGID INTERNAL FIXATION SYSTEM (K021618)Osteomed Corp.2002-08-08
ALPHA DRIVE SYSTEM (K013396)Alpha Omega , Ltd.2002-08-07
COAMATIC AT-400 (K022195)Instrumentation Laboratory CO2002-08-07
MDA D-DIMER (K021877)bioMerieux, Inc.2002-08-07
K-Y BRAND WARMING LIQUID PERSONAL LUBRICANT (K021492)Personal Products Co., Div. of Mcneil Ppc, Inc.2002-08-07
800 SERIES EASYNEB NEBULIZER (K020357)Nellcor Puritan Bennett, Inc.2002-08-07
ULTIMA SNORING MIKE, MODEL 0540 (K020312)Braebon Medical Corp.2002-08-07
OPUSDUO EC DENTAL LASER SYSTEM (K021508)Opusdent , Ltd.2002-08-07
PERF (OMMAYA STYLE) RESERVOIRS (K021644)Phoenix Biomedical Corp.2002-08-06
PRISMA SYSTEM (K010805)Gambro Renal Products2002-08-06
QUANTITATIVE BLOOD POOL SPECT (QBS) (K022428)Adac Laboratories2002-08-06
SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X (K022065)Sintea Biotech, Inc.2002-08-06
EASYTEM EAR THERMOMETER, MODEL BT-020 (K020520)Metatech Co., Ltd.2002-08-06
BLACKSTONE SPINAL FIXATION SYSTEM SPACER (K022399)Blackstone Medical, Inc.2002-08-06
BRESAGEN CATHETER, MODEL CS-3000 (K021481)Bresagen, Inc.2002-08-06
LODOX, MODEL BASELINE (K013999)Lodox Systems (Pty), Ltd.2002-08-06
E-CARE INFARED EAR THERMOMETER, MODEL LCT-200 (K021753)E-Care Technology Corporation2002-08-06
ADC DENTAL (K021542)Agfa Corp.2002-08-06
CYTOFLEX MESH (K021511)Unicare Biomedical, Inc.2002-08-06
ROSSMAX AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODELS B150 & Q400 (K020897)Rossmax Internationl , Ltd.2002-08-06
HMS-DHR-3 NEUROMUSCULAR STIMULATOR (K021472)Home Medical Services2002-08-06
F 900 (K022054)C.S.O. S.R.L.2002-08-06
SSA-700A, APLIO DIAGNOSTIC ULTRASOUND SYSTEM (K022400)Toshiba America Medical Systems, In.C2002-08-06
CRYOBAG, MODEL CB (K021702)Origen Biomedical, Inc.2002-08-06
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Every clearance here is in the API, with alerts when new ones post.