Atlas FDA

1997

4,309 FDA 510(k) clearances · Clearance year

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RecordFirmDate
COAG-A-MATE MTX (K962857)Organon Teknika Corp.1997-01-22
BRENTWOOD PC-ECG (K955023)Brentwood Medical Products, Inc.1997-01-22
MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER (K963480)Deroyal Industries, Inc.1997-01-22
NORTHWEST PRECISION TECHNOLOGIES 6.5 MM CANNULATED CANNULATED CANCELLOUS SCREW (K963937)Northwest Precision Technologies1997-01-22
A.C.T. I (K965149)Remel Co.1997-01-22
HEARTPORT ENDOCORONARY SINUS CATHETR (K964248)Heartport, Inc.1997-01-22
TETRIC CERAM (K964285)Ivoclar North America, Inc.1997-01-22
DISPOSABLE LIMB HOLDER (K963476)Deroyal Industries, Inc.1997-01-22
DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL) (K964619)Sds Dental, Inc.1997-01-22
A.C.T. II (K965152)Remel Co.1997-01-22
BASIC BIOPSY TRAY. DISPOSABLE, STERILE (K964921)Trinity Laboratories, Inc.1997-01-22
A.C.T. III (K965151)Remel Co.1997-01-22
HEMASHIELD VANTAGE (VASCULAR GRAFT (K961847)Meadox Medicals, Div. Boston Scientific Corp.1997-01-22
DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED (K963548)Mrlb Intl., Inc.1997-01-22
SAFETY INJECTION SYSTEM (K962999)Integritech, Inc.1997-01-22
BIAFINE WOUND DRESSING EMULSION (K964240)Medix Pharmaceuticals Americas, Inc.1997-01-22
APPLIED MEDICAL CLIP APPLIER (K964470)Applied Medical Resources1997-01-22
AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT (K964381)Avanta Orthopaedics, Inc.1997-01-22
NOVABED PATIENT TRANSFER SYSTEM (K964246)Nova Technology Corp.1997-01-22
OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODIT,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN (K963319)Custom Services Intl., Inc.1997-01-22
RICHARDS TOTAL/PARTIAL PROSTHESIS (K962564)Gyrus Ent LLC1997-01-22
OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN (K963322)Custom Services Intl., Inc.1997-01-22
LC-250 INFRARED LIGHT COAGULATOR (K964380)Nk-Optik America1997-01-22
AUTOPRIME (K964283)Arbor Technologies, Inc.1997-01-22
ACS HI-TORQUE IRON MAN GUIDE WIRE (K963702)Advanced Cardiovascular Systems, Inc.1997-01-22
ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE (K964754)Ortho Diagnostic Systems, Inc.1997-01-22
SERAQUEST HSV IGG (K963282)Quest Intl., Inc.1997-01-22
MEDOFF SLIDING PLATE (PROPOSED NAME) (K962251)Wrightmedicaltechnologyinc1997-01-22
OLYMPUS,JASMINE,JIMMY-O RAINCOAT,DRINK,ARES,APHRODITE,ZEUS,APOLLO,SELFCARE,CAREPLUS,TITAN (K963321)Custom Services Intl., Inc.1997-01-22
PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR (K964525)Dentsply Intl.1997-01-22
DIASONICS ITNRAOPERATIVE PROBES (K961002)Diasonics Ultrasound1997-01-22
HCL - 200 BIOCHEMISTRY ANALYZER (K964409)Hcl Laboratory Systems, Inc.1997-01-22
PONCHO VEST RESTRAINT (K963475)Deroyal Industries, Inc.1997-01-22
SEALITE SCIENCES, INC. AQUALITE LH (K964925)Sealite Sciences, Inc.1997-01-22
TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5 (K963263)Coulter Corp.1997-01-22
SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC) (K964279)Graphic Controls Corp.1997-01-22
CO 2 SMO PLUS (K963380)Novametrix Medical Systems, Inc.1997-01-22
A.C.T. IV (K965150)Remel Co.1997-01-22
IMMUNOCARD H. PYLORI (K961508)Meridian Diagnostics, Inc.1997-01-21
GLUCOMETER DEX DIABETES CARE SYSTEM (K963500)Bayer Corp.1997-01-21
AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST (K964574)Athena Medical Corp.1997-01-21
CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT (K954214)Vysis1997-01-21
SAS ONE-STEP PREGNANCY (K964995)Sa Scientific, Inc.1997-01-21
ELECSYS PROLACTIN ASSAY (K964748)Boehringer Mannheim Corp.1997-01-21
TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II (K964639)Telex Communications, Inc.1997-01-21
NEUROGUARD TRANSCRANIAL DOPPLER ULTRASOUND SYSTEM (K962796)Medasonics, Inc.1997-01-21
SIRIUS 10, 10L, 40, 40L (K961275)Micro-Mega Societe Anonyme1997-01-17
CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 1 (K965157)Boehringer Mannheim Corp.1997-01-17
XRT-7.0 (K964583)Elscint, Inc.1997-01-17
AQUARIUS HPF (WILL BE SOLD AS WILLIAMS CLASSIC VISIONS) (K964772)Ivoclar North America, Inc.1997-01-17
PRESCOTT'S LIGHT SOURCE MODEL NO. II-150 (K964586)Iba/Griffith1997-01-17
AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR (K964816)Audina Hearing Instrument1997-01-17
IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ (K963695)Diagnostic Products Corp.1997-01-17
FEMRX MORCELLATOR SYSTEM (K963872)Gynecare Innovation Center1997-01-17
OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR (K962648)Ohmeda Medical1997-01-17
MEDILOG MR95 (K961642)Oxford Instruments, Plc.1997-01-17
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY (K964306)General Electric Co.1997-01-17
HSW GMBH ARTHROSCOPE (K962075)Henke Sass Wolf of America, Inc.1997-01-17
ORTHODOC PREOPERATIVE PLANNER MODEL 500 (K960685)Integrated Surgical Systems, Inc.1997-01-17
MEDILOG VISION (K961636)Oxford Instruments, Plc.1997-01-17
SIEMENS SC 6000 & SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM (K962404)Siemens Medical Solutions USA, Inc.1997-01-17
BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE) (K964330)BioHorizons Implant Systems, Inc.1997-01-17
AST/SGOT (K965126)Derma Media Lab., Inc.1997-01-17
SIGMA DIAGNOSTICS GLUCOSE REAGENT (K963535)Sigma Diagnostics, Inc.1997-01-17
OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY (K964304)Osteonics Corp.1997-01-17
MEDILOG MPA-S (K961638)Oxford Instruments Medical Systems1997-01-17
DIGITAL IMAGE ANALYSIS SYSTEM (K962153)University of Washington1997-01-17
PULPDENT SNOOP (K964430)Pulpdent Corp.1997-01-17
DIGISCOPE RX-2 (9 OPTION) (K965013)Medirex, Inc.1997-01-17
PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE (K962175)Smiths Industries Medical Systems, Inc.1997-01-17
APEX UNIVERSAL DRIVE SYSTEM (K964548)Linvatec Corp.1997-01-17
IPU RX-2 (K964327)Medirex, Inc.1997-01-17
CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION (K964856)Caltag Laboratories, Inc.1997-01-17
CTS MIDCAB/SVH BIPOLAR SCISSORS (K963930)Cardiothoracic Systems, Inc.1997-01-16
MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA (K964350)Intermedics Orthopedics1997-01-16
PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25 (K960508)The Prometheus Group1997-01-16
SOFSILK (K964581)United States Surgical, A Division of Tyco Healthc1997-01-16
OMNIPULSE/OMNIPULSE-MAX (K962632)Trimedyne, Inc.1997-01-16
SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM (K950099)Buckman Co., Inc.1997-01-16
CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC ASPIRATOR/CUSA LAP ACCESSORY (K964601)Valleylab, Inc.1997-01-16
KINAMED PROFIX SYSTEM (K964362)Kinamed, Inc.1997-01-16
INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL DISCISION OF PERFORATING VINS ESDP, MODEL 8781 (K964258)Richard Wolf Medical Instruments Corp.1997-01-16
WALLACE ARTIFICIAL INSEMINATION CATHETER - 8CM/18CM (K964848)Marlow Surgical Technologies, Inc.1997-01-16
BHI W/VANCOMYCIN AGAR (K964560)Hardy Diagnostics1997-01-15
N RHEUMATOLOGY STANDARD SL (K964527)Behring Diagnostics, Inc.1997-01-15
700-FR SERIES RADIOLUCENT STIMULATION ELECTRODES (K964991)Cardiotronics Systems, Inc.1997-01-15
OLYMPUS LIPASE REAGENT (K963424)Olympus America, Inc.1997-01-14
MAYO HIP PROSTHESIS (K943230)Mayo Clinic1997-01-14
PHOENIX ETE TISSUE EXTENSION SYSTEM (K962144)Phoenix Biomedical Corp.1997-01-14
SEGUE INFUSION CATHETER (K964154)Interventional Innovations Corp.1997-01-14
HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER (K962220)Marquest Medical Products, Inc.1997-01-14
WATER CHAMBERS FOR ST 3000 HEATED HUMIDIFIER (K962223)Marquest Medical Products, Inc.1997-01-14
METAL ACETABULAR COMPONENT (K964227)Encore Orthopedics, Inc.1997-01-14
ALPHA POSTERIOR SPINAL SYSTEM (K964275)Sofamor Danek USA,Inc.1997-01-14
BRIDGE LONG STEM FEMORAL COMPONENT (K964249)Wrightmedicaltechnologyinc1997-01-14
CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE (K962873)Vysis1997-01-13
VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM (K964587)Bayer Corp.1997-01-13
11F GUIDING CATHETER (K963663)Boston Scientific /International Technologies1997-01-13
ASC HIGH PRESSURE BRAIDED TUBES (K964331)Adam Spencer Corp.1997-01-13
AURORA 53 (K964949)Gateway Alloys, Inc.1997-01-13
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