Atlas FDA

1995

5,487 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH] (K951566)Baxter Healthcare Corp1995-11-27
NIHON KOHDEN WEP-8430A CENTRAL TELEMETRY SYSTEM (K945944)Nihon Kohden America, Inc.1995-11-27
MILL-ROSE RIGID SCOPE CLEANING BRUSHES (K954745)Mill-Rose Laboratory1995-11-27
SHARPS DISPOSAL CONTAINERS (K953797)Bemis Mfg. Co.1995-11-27
RADIFOCUS INTRODUCER II KIT (K954234)Terumo Medical Corp.1995-11-27
EXPANDACELL INJECTO-PAK NASAL PACK (K954845)Shippert Medical Technologies Corp.1995-11-27
CONMED TROGARD ELECTRONIC TROCAR SYSTEM (K954599)Conmedcorp1995-11-27
ANTI-TPO (K954256)Biomerica, Inc.1995-11-27
CHARISMA SINGLE DOSE (K954929)Heraeus Kulzer, Inc.1995-11-27
MODEL NOS. 7495 AND 501826 EXTENSIONS (K954886)Medtronic Vascular1995-11-27
ALKALINE PHOSPHATASE REAGENT SYSTEM (K952746)Medical Diagnostic Technologies, Inc.1995-11-27
DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES (K954989)Smith & Nephew Dyonics, Inc.1995-11-27
CEDIA DAU BENZODIAZEPINE ASSAY(MODIFICATION) (K954626)Microgenics Corp.1995-11-27
SYNTHES CANNULATED ANGLE BLADE PLATE (K954289)Synthes (Usa)1995-11-24
SIGNA ADVANTAGE SP MAGNETIC RESONANCE SYSTEM (K942604)GE Medical Systems1995-11-24
PENTAX ULTRASOUND ENDOSCOPE MODEL FG-32UA (MODIFICATION) (K953876)Pentax Precision Instrument Corp.1995-11-24
AQUASOFT (TETRAFILCON A) DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS (K954139)CooperVision, Inc.1995-11-24
HUMPHREY FIELD ANALYZER (HFA II) (K954167)Carl Zeiss, Inc.1995-11-24
VERTEX EPIC MCD (K952684)Adac Laboratories1995-11-24
KOWA PORTABLE SLIT LAMP SL-14 & SL-14B (K954782)Kowa Optimed, Inc.1995-11-24
KENDALL SAFETAP SPINAL ANESTHESIA TRAY (K953766)Kendall Healthcare Products Co. Div.Of Tyco Health1995-11-24
VOXELVIEW (K953259)Vital Images, Inc.1995-11-24
CHOLESTECH LDX SYSTEM (K954778)Cholestech Corp.1995-11-24
GYREX PRIVILEGE (K954039)Elscint, Inc.1995-11-24
MPH50, MPH65, AND MPH80 (K954666)GE Medical Systems1995-11-24
LASERNET IMAGE MANAGER/PRINT SERVER (K952485)Frantz Imaging, Inc.1995-11-24
CORTICELLOUS BONE SCREW (K953198)Hayes Medical, Inc.1995-11-24
BODYSTAY (K951097)Bodystat , Ltd.1995-11-22
WALLACH DIGITAL IMAGING SYSTEM (K950630)Wallach Surgical Devices, Inc.1995-11-22
OSTEONICS SECUR-FIT HA PSL EXTRA ACETABULAR COMPONENT SYSTEM (K954023)Osteonics Corp.1995-11-22
CASPER (K953227)Northwest Medical Physics Center1995-11-22
NIHON KOHDEN ZB-831PA TELEMETRY TRANSMITTER (K946175)Nihon Kohden America, Inc.1995-11-22
XCHF-33 CHOLEDOCHOFIBERSCOPE (K944473)Olympus America, Inc.1995-11-22
AXSYM TRICYCLIC ANTIDEPRESSANTS (K953761)Abbott Laboratories1995-11-22
PROBE PERSONAL LUBRICANT - SILKY LIGHT (K952465)Davryan Laboratories, Inc.1995-11-22
ALPHA LONG STEM FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL) (K951139)Wrightmedicaltechnologyinc1995-11-22
APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH SOES RATE AFTERLOADER (K952913)Varian Assoc., Inc.1995-11-22
CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER (K953768)Cordis Webster, Inc.1995-11-22
RESECTOSCOPES (K954050)KARL STORZ Endoscopy-America, Inc.1995-11-22
MODEL IPD OXYGEN CONSERVING DEVICE (K953852)Invacare Corp.1995-11-22
HP ECHO IMAGE MANAGEMENT SYSTEM (K954668)Hewlett-Packard Co.1995-11-22
RESPOSABLE RESUSCITATOR (K953617)Medical Marketing Concepts1995-11-22
ARISTO MEDICAL MODEL 2101 PATIENT MONITOR (K953817)Aristo Medical Products, Inc.1995-11-22
AUTO SUTURE* STERILIZATION TRAY** (K954090)United States Surgical, A Division of Tyco Healthc1995-11-22
DURASIL (K952612)The S. F. Group, Inc.1995-11-22
HILL-ROM AMBULATORY CARE PROCEDURAL STRETCHER (K952447)Hill-Rom, Inc.1995-11-22
CP 100/30 (K953292)Micro-Focus Imaging., Inc.1995-11-22
VARICAM (K953801)Elscint, Inc.1995-11-22
POCKETALKER PRO (K954748)Williams Sound, LLC1995-11-22
PROBE PERSONAL LUBRICANT - CLASSIC (K952464)Davryan Laboratories, Inc.1995-11-22
BIOCIRCUITS IOS (IN-OFFICE SYSTEM) (K952719)Biocircuits Corp.1995-11-22
OPERATING LARYNGOSCOPES & ACCESSORIES FORCEPS, PROTECTORS (K953771)KARL STORZ Endoscopy-America, Inc.1995-11-22
BRONCHOSCOPE (K954707)Fujinon, Inc.1995-11-22
SELECT IUI (K954099)Select Medical Systems, Inc.1995-11-22
PARALLEL (K954007)Johnson & Johnson Consumer Products, Inc.1995-11-22
INSPECT/PROSPECT (K952564)Adac Laboratories1995-11-22
BECTON DICKINSON SYRINGSE (K954064)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-11-21
ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPS (K952875)Boehringer Mannheim Corp.1995-11-21
SIEMENS Q4000 (K945072)Siemens Medical Solutions USA, Inc.1995-11-21
FLUSHIES FLUSHABLE/BIODEGRADABLE MENSTRUAL PADS/NAPKINS (ULTRA THINS) (K953470)Mediquip, Inc.1995-11-21
ATLAS ORTHOGONAL PERCUSSION INSTTUMENT (K951217)Sweat Chiropractic Clinic1995-11-21
CABOT MEDICAL REUSABLE BIPOLAR CUTTING FORCEPS (K946109)Cabot Medical Corp.1995-11-21
FLOSCOPE SUPER VASCULAR LAB (K943200)Advance Medical Device, Inc.1995-11-21
IMPERIUM (K953905)Teledyne Brown Engineering1995-11-21
LOW PROFILE CATHETER (K922567)Rusch, Inc.1995-11-21
MEDTRONIC GC IV CORONARY GUIDING CATHETER (K950490)Medtronics Interventional Vascular1995-11-21
PER-Q-CATH & PER-Q-CATH DUAL MUMEN CATHETERS, TRAYS & ACCESSORY DEVICES (K954104)C.R. Bard, Inc.1995-11-21
SELECTCELLS STANDARD (K954097)Select Medical Systems, Inc.1995-11-21
INCLUSICE II(TM) ENDOSCOPE (K946087)Sofamor Danek USA,Inc.1995-11-21
DURACON MONOLITHIC STABILIZER FEMORAL COMPONENT (K954138)Howmedica Corp.1995-11-21
GENESIS (K953345)Tecan U.S., Inc.1995-11-21
DANTEC DA CAPO (K953999)Dantec Medical, Inc.1995-11-21
IMZ BONE TACK SYSTEM (K952167)Interpore Intl.1995-11-21
Z-WATCH SYSTEM (K951727)Prizm Medical, Inc.1995-11-21
MICROGLISS (K954180)Espe GmbH & Co. Kg.1995-11-21
COAGUCHEK SYSTEM (K952625)Boehringer Mannheim Corp.1995-11-21
LOW PROFILE SAFSITE Y-SITE (K954123)B.Braun Medical, Inc.1995-11-21
SELECTMUCUS (K954102)Select Medical Systems, Inc.1995-11-21
EMC MODEL STATOME 200 (K952231)Emc Industries1995-11-21
AMSET R-F SYSTEM (K951266)Advanced Spine Technology, Inc.1995-11-21
ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (K954825)Bio-Rad Laboratories, Inc.1995-11-21
ABG POINT LOK NEEDLE PROTECTION DEVICE (K954015)Devon Industries, Inc.1995-11-20
MAX-1000A/R1 (K954590)Toshiba America Medical Systems, In.C1995-11-20
THYROGLOBULIN EIA TEST KIT (K951362)Immunoprobe, Inc.1995-11-20
MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT (K946258)Spinalight, Inc.1995-11-20
VARIANT HEMOGLOBINOPATHY PROGRAM (K954048)Bio-Rad1995-11-20
GIBSON ID A.E. TEST (K953247)Gibson Laboratories, Inc.1995-11-20
HITACHI DYNAMIC 3D IMAGING SYSTEM,SF-VA100 (K945400)Hitachi Medical Corp. of America1995-11-20
ACCESS TOTAL BHCG ASSAY (MODIFICATION) (K954732)Bio-Rad Laboratories, Inc.1995-11-20
HYSTEROSYS FLEXIBLE HYSTEROCOPE (K951946)Ovamed Corp.1995-11-20
MICROSOMAL EIA TEST KIT (K951364)Immunoprobe, Inc.1995-11-20
COACUTE HEPARIN (K952514)Chromogenix AB1995-11-20
CALCITONIN IMMUNOASSAY KIT (K945961)Nichols Institute Diagnostics1995-11-20
LEKSELL GAMMA UNIT MODEL 23004,TYPE B. (K924849)Elekta Radiosurgery, Inc.1995-11-20
ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII (K952818)Pyramid Biological Corp.1995-11-20
KEY-LOK(TM) SYSTEM (K940645)St. Paul Medical1995-11-20
FACS LOADER SYSTEM (K953302)Becton Dickinson Immunocytometry Systems1995-11-20
CAD-2000 CARDIAC ASSIST DEVICE (K951124)Eee Medical Ent.1995-11-20
GRAHAM-FIELD SALINE ELECTROLYTE GEL (K944600)Chester Labs, Inc.1995-11-20
ZIMMER RECONSTRUCTION SYSTEM SYMPHYSEAL BONE PLATE (K953714)Zimmer, Inc.1995-11-20
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Track 1995 automatically

Every clearance here is in the API, with alerts when new ones post.