Atlas FDA

2002

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

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RecordFirmDate
INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT (K013483)Hollister, Inc.2002-01-14
KAVO POLYLUX II (K013500)Kavo America2002-01-14
NOTTA AMBULATORY RECORDER (K013450)Stellate Systems2002-01-14
84 CHANNEL EEG (K014146)Xltek2002-01-14
HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, M3840A, M3841A (K013425)Philips Medical Systems2002-01-14
REUSE CLAIM FOR THE BARD ELECTROPHYSIOLOGY SURELINK, TEMPLINK, AND TEMPLINK M EXTENSION CABLES (K013598)C.R. Bard, Inc.2002-01-11
NUTRISAFE PUR ENTERAL FEEDING TUBE (K003311)Vygon Corp.2002-01-11
SMARTMONITOR 2, MODEL 4000 (K011597)Respironics Georgia, Inc.2002-01-11
MODIFICATION TO SUPERCROSS CATHETER (K014118)Abbott Vascular, Inc.2002-01-11
RANDOX DIGITOXIN (K012112)Randox Laboratories, Ltd.2002-01-11
ACTAEON PROBE (K013429)Osteobiologics, Inc.2002-01-11
WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860 (K014121)Nellcor Puritan Bennett, Inc.2002-01-11
SYNTHES ANKLE ARTHRODESIS PLATE (K013415)Synthes (Usa)2002-01-11
MODIFICATION TO OUTBACK CATHETER (K014117)Lumend, Inc.2002-01-11
BODYFIX (K013391)Medical Intelligence Medizintechnik GmbH2002-01-11
MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (K014094)Hill-Rom Manufacturing, Inc.2002-01-11
HYDROFERA BACTERIOSTATIC WOUND DRESSING (K013462)Hydrofera, LLC2002-01-11
MINIBLASTER (K013969)Deldent , Ltd.2002-01-10
INTUITIVE SURGICAL ENDOWRIST ENDOSCOPIC INSTRUMENT FAMILY (K013416)Intuitive Surgical, Inc.2002-01-10
INFINITY EXPLORER (K013515)Siemens Medical Solutions USA, Inc.2002-01-10
ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752 (K013078)Helena Laboratories2002-01-10
DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES (K013389)Datex-Ohmeda2002-01-10
BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM (K013383)Biomedical Implant Technology, Inc.2002-01-10
MAC 5000 ECG ANALYSIS SYSTEM (K014108)General Electric Medical Systems Information Techn2002-01-10
TRIAGE TOX DRUG SCREEN, CATALOG #94000 (K012745)Biosite Incorporated2002-01-10
GE LOGIQ 5 (K014097)GE Medical Systems2002-01-10
BODYGEM, MODEL HB211 (K010577)Healthetech, Inc.2002-01-10
7MM EXTENDED LENGTH ENDOSCOPE,DISSECTION TIPS, MODELS VH-1111, VH-1114 (K014250)Guidant Corp.2002-01-10
MISONIX IRRIGATION SYSTEM MOEDL BC20P (K013417)Misonix, Inc.2002-01-10
IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6 (K012075)Diagnostic Products Corp.2002-01-10
IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6 (K012077)Diagnostic Products Corp.2002-01-10
LIGHT PROJECTOR WITH ENDOSCOPIC CAMERA, 1 CCD CAMERA HEAD NTSC, 1 CCD CAMERA HEAD PAL, LIGHT PROJECTOR, MODEL 5551.107 (K010033)Richard Wolf Medical Instruments Corp.2002-01-10
VENTED VIAL ACCESS DEVICE (K013950)Churchill Medical Systems, Inc.2002-01-10
DYNAPULSE 5200A PATHWAY BLOOD PRESSURE MONITORING SYSTEM (K013478)Pulse Metric, Inc.2002-01-10
POINT 4 TRANSLUCENT MODIFIED (K013529)Sybron Dental Specialties, Inc.2002-01-09
COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1 (K013243)Bioform, Inc.2002-01-09
NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE (K013385)Zimmer, Inc.2002-01-09
EPOCA CODR STEM AND HEAD (K014049)Stelkast Company2002-01-09
HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM (K014083)Haemonetics Corp.2002-01-08
DATEX-OHMEDA S/5 WEB VIEWER (K013387)Datex-Ohmeda2002-01-08
NLITE SYSTEM (K014130)Icn Photonics , Ltd.2002-01-08
MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10 (K013695)Microline Pentax, Inc.2002-01-08
WAMPOLE HS-CRP ELISA (K011855)Carter-Wallace, Inc.2002-01-08
RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM (K011238)Metracor Technologies, Inc.2002-01-08
CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA (K013589)Supermax Glove Manufacturing Sdn Bhd2002-01-08
ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM (K014078)On Site Gas Systems, Inc.2002-01-08
OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND (K014100)Opusdent , Ltd.2002-01-08
PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE REMOVAL OF TATTOOS (K013365)Medical Bio Care Sweden AB2002-01-08
EXTREMITY COIL (K013592)Usa Instruments, Inc.2002-01-08
LIFEGUARD NASAL CPAP MASK AND ACCESSORIES (K013421)Lifeguard Medical Products, Inc.2002-01-08
SABRE COMPAC (K011842)Sle Limited2002-01-08
BICART (K013724)Gambro Renal Products2002-01-08
PROLITE PULSED LIGHT SYSTEM FOR THE REMOVAL OF UNWANTED HAIR (K013366)Medical Bio Care Sweden AB2002-01-08
DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN (K013956)Diamedix Corp.2002-01-08
SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SYSTEM) (K011190)Surx, Inc.2002-01-08
SEAL-ON TOPICAL HEMPSTATIC POWDER SPRAY (K010933)Alltracel Pharma , Ltd.2002-01-08
GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR (K013718)Gynecare, A Div. of Ethicon, Inc.2002-01-08
BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT (K013062)Biocheck, Inc.2002-01-08
L-25 ABSORBABLE SURIGCAL SUTURE (K013671)United States Surgical, A Division of Tyco Healthc2002-01-08
BOEHRINGER MRI SUCTION REGULATORY (K013976)Boehringer Laboratories2002-01-08
VIABAHN ENDOPROSTHESIS (K013648)W. L. Gore & Associates, Inc.2002-01-08
APEX ADULT HOLLOWE FIBER OXYGENATOR (K014080)Dideco S.P.A.2002-01-08
TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM (K013775)Stryker Leibinger2002-01-08
DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2 (K011876)Circon Video2002-01-08
ROCHE ACETAMINOPHEN (K013757)Roche Diagnostics Corp.2002-01-08
PJ.S COMFORT PORTABLE ELECTRIC BREAST PUMP (K012275)Limerick, Inc.2002-01-07
DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM (K014007)Guidant Corp.2002-01-07
INCARE INTERMITTENT CATHETER (K013345)Hollister, Inc.2002-01-07
CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013 (K013523)Shire Biologics, Inc.2002-01-07
DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 HFS, POLYSULFONE 130 HFS (K011537)Dynamic Technology Corp.2002-01-07
NYCOCARD CRP CONTROL (K014084)Primus Corp.2002-01-07
SHARGHP A.V. FISTULA NEEDLE SET (K013384)Shargh Pharmaceutical Co., Inc.2002-01-07
M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540 (K014191)Philips Medical Systems2002-01-07
SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE) (K014037)St. Jude Medical, Inc.2002-01-04
PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL, (K013174)Porges S.A.2002-01-04
NEOLEAD (K011564)Neotech Products, Inc.2002-01-03
YELLOW SPECIAL (K013506)Metalor Technologies USA2002-01-03
NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR (K013319)Nonin Medical, Inc.2002-01-03
3420 DIGIT PULSE OXIMETER, MODEL 3420 (K013171)Bci, Inc.2002-01-03
TETRAD MODEL TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP TRANSDUCERS (K014182)Tetrad Corp.2002-01-03
NUMED MULLINS PTA CATHETER (K013601)NuMED, Inc.2002-01-03
MODIFICATION TO: POCKETVIEW ECG SOFTWARE (K013311)Micromedical Industries, Ltd.2002-01-03
BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER (K013304)Becton Dickinson Infusion Therapy Systems, Inc.2002-01-02
PHSL-63 PEDIATRIC HEAD AND SPINE ARRAY COIL (K013514)Mri Devices Corp.2002-01-02
CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 (K003689)Canon USA, Inc.2002-01-02
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Every clearance here is in the API, with alerts when new ones post.