Atlas FDA

1998

3,775 FDA 510(k) clearances · Clearance year

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RecordFirmDate
NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)Nova Biomedical Corp.1998-04-15
NTECH ARTHROSCOPE (K980599)N-Tech Endoscopy, Inc.1998-04-15
STRATUS CS MYO CALPAK (K981101)Dade Behring, Inc.1998-04-15
DENOPTIX BARRIER ENVELOPE (SIZE 0-4) (K980543)Dentsply Intl.1998-04-14
PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE (K972201)Sulzer Carbomedics, Inc.1998-04-14
BIOFIX BIODEGRADABLE THREADED SUTURE ANCHOR (K972783)Bionx Implants, Inc.1998-04-14
IMPLEX HEP ACETABULAR REVISION CUP, CEMENTED OR CEMENTLESS MODEL A-240 SYSTEM (K980486)Implex Corp.1998-04-14
BIOSYMMETRIC PROXIMAL INTERPHALANGEAL JOINT FIXATOR (K980370)Biomet, Inc.1998-04-14
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM (K980447)DePuy Orthopaedics, Inc.1998-04-14
DEPUY MOTECH PEAK 3MM FIXATION ROD SYSTEM (K980368)Depuy, Inc.1998-04-14
UNIVERSITY PLATE ANTERIOR SYSTEM (K980228)Acromed Corp.1998-04-14
RUSCH SINGLE USE CRYSTAL TRACHEOSTOMY TUBE SET (K972546)Rusch Intl.1998-04-14
ENVOY PATIENT MONITOR (K974510)Mennen Medical, Inc.1998-04-14
LOW PROTEIN LATEX PATIENT EXAMINATION GLOVES (POWDER-FREE) (K980605)Pt. Sarana Indoprotex1998-04-14
MUSCLE RESPONSE MONITOR (K971400)Enriching Your Life1998-04-14
CH-611B AND CH-611C DIGITAL WRIST SPHYGMOMANOMETERS BLOOD PRESSURE METER (K973613)Foley & Lardner1998-04-14
AR SAFE NITRILE EXAMINATION GLOVES (K980589)Alliance Rubber Products Sdn. Bhd.1998-04-14
WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER (K980496)Wrightmedicaltechnologyinc1998-04-14
ARTICUL/EZE FEMORAL HEADS (K980513)DePuy Orthopaedics, Inc.1998-04-14
PREMIER 7000 CTL SPINE COIL (K980157)Usa Instruments, Inc.1998-04-13
TELICAM (K980474)Dental/Medical Diagnostic Systems, Inc.1998-04-13
YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION (K980147)Automatic Liquid Packaging, Inc.1998-04-13
SHARPS PLUS 5 GALLON SHARPS CONTAINER (K980179)Rotonics Mfg., Inc.1998-04-13
HISPEED QX/I CT SCANNER SYSTEM (K980176)General Electric Co.1998-04-13
HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMS (K980169)General Electric Co.1998-04-13
FUJI I (K980695)GC America, Inc.1998-04-13
FLOW RIDER FLOW DIRECTED MICRO CATHETER (K980104)Micro Therapeutics, Inc.1998-04-10
AMT DECOMPRESSION TUBES (K980145)Applied Medical Technology, Inc.1998-04-10
CV PERI-GUARD - CARDIOVASCULAR PATCH (K971726)Bio-Vascular, Inc.1998-04-10
CO2 PNEUMO-DISSECTOR (K972647)Cook Urological, Inc.1998-04-10
TEMPORARY CARDIAC PACING WIRE (K980503)ETHICON, Inc.1998-04-10
ENDOCRE CRYOCARE CRYOSURGICAL SYSTEM (K980110)Endocare, Inc.1998-04-10
VAPORIZATION ELECTRODES (K970961)Richard Wolf Medical Instruments Corp.1998-04-10
REMOTE HAND CONTROL TO THE INFLATABLE POSITIONING CUSHION (A.K.A. IMAGEAIR) (K980235)Kci New Technologies, Inc.1998-04-09
LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND) (K970761)Cambridge Diagnostics Ireland, Ltd.1998-04-09
PERIACRYL (K974097)Blacklock Medical Products, Inc.1998-04-09
HUMAN LYME IGM WESTERN BLOT KIT (K970768)Cambridge Diagnostics Ireland, Ltd.1998-04-09
MINISTRIP/ SERUM AND URINE COMBO HCG TEST (K974060)International Newtech Development, Inc.1998-04-09
KHT SOFT NEEDLE, ACUPUNCTURE NEEDLE (K980472)American Institute of Koryo Hand Therapy1998-04-09
MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER (K980617)Urohealth Systems, Inc.1998-04-09
OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01 (K980159)Closure Medical Corp.1998-04-09
SORBASTACE (K965034)Hemostace, LLC1998-04-09
COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES (K980079)Lumenis, Inc.1998-04-09
ONE STEP MIDSTREAM HCG PREGNANCY TEST (K974059)International Newtech Development, Inc.1998-04-09
BIODERM CALCIUM ALGINATE DRESSING (K980451)Bioderm, Inc.1998-04-09
S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD (K980081)Johnson & Johnson Professionals, Inc.1998-04-09
VACUETTE HOLDEX (K980768)Greiner Meditech, Inc.1998-04-09
LUBRISCAN ULTRA SCAN GEL +, MODEL RG2-60 (K980091)Cosmaceutical Marketing, Inc.1998-04-09
KHT GUAM NEEDLE, ACUPUNCTURE NEEDLE (K980471)American Institute of Koryo Hand Therapy1998-04-09
BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY (K980541)Barco NV Display Systems1998-04-09
ULTRACISION LAPAROSONIC COAGULATING SHEARS (LCS-5(LCSK5 AND LCSB5)) (K980099)Ethicon Endo-Surgery, Inc.1998-04-09
BETTER-TUBING (K964205)Circulatory Technology, Inc.1998-04-08
GYNEX ENDOSPECULUM (K980237)Gynex Corp.1998-04-08
LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B (K974302)Light Diagnostics1998-04-08
URESIL NEPHRO-URETERAL STENT (K980889)Uresil Corp.1998-04-08
ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000) (K963703)International Biophysics Corp.1998-04-08
AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY (K973697)Airperm, Inc.1998-04-08
FETAL D TECTION KIT (K980314)Biopool Intl., Inc.1998-04-08
COLOURED POWDWR-FREE SURGICAL GLOVES (K980412)Kenwell International , Ltd.1998-04-08
HORTMANN AMDIS-OAE OAE ANALYZER (K980505)Hortmann AG1998-04-07
KEELER TEARSCOPE-PLUS (K973064)Keeler Instruments, Inc.1998-04-07
ALDEN CLASSIC TINTED (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS, TINTED (TRANSPARENT/ENHANCING) (K980554)Alden Optical Labs., Inc.1998-04-07
NEVA SYSTEM (K980627)Urometrics, Inc.1998-04-07
LYPHOCHEK WHOLE BLOOD CONTROL (K980871)Bio-Rad1998-04-06
KHT SOFT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE (K980470)American Institute of Koryo Hand Therapy1998-04-06
MANAN (K974743)Medical Device Technologies, Inc.1998-04-06
IV STANDS (K980336)Clinton Industries, Inc.1998-04-06
MANAN POTTS-COURNAND NEEDLE (K974742)Medical Device Technologies, Inc.1998-04-06
MANAN GWI GUIDE WIRE INTRODUCER (K974745)Medical Device Technologies, Inc.1998-04-06
RELEASABLE FORCE MODULE (K980151)Ortho Kinetics Corp.1998-04-06
SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT (K980138)Spectrum Designs, Inc.1998-04-03
PROFUSION BONE VOID FILLER (K973704)Biogeneration1998-04-03
KHT SOOJI NEEDLE, HAND ACUPUNCTURE NEEDLE (K980469)American Institute of Koryo Hand Therapy1998-04-03
MODEL PS-1 PENA MUSCLE STIMULATOR (K980448)Radionics, Inc.1998-04-03
SAFETY POWDERFREE BLUE LATEX EXAMINATION GLOVES (POLYMER COATED) (K980941)Besglove Medicare Sdn. Bhd.1998-04-03
STERILE POWDER-FREE LATEX EXAMINATION GLOVES (K980803)Kenwell International , Ltd.1998-04-03
REJUVENESS (K974380)Rejuveness Pharamceuticals, Inc.1998-04-03
THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER (K972824)Pn Medical1998-04-03
ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY (K980716)Nichols Institute Diagnostics1998-04-03
ENDOBON (K980679)Biomet, Inc.1998-04-03
MLT R694 RUBY LASER SYSTEM (K980187)Medical Laser Technologies , Ltd.1998-04-03
FEATHERLITE DIODE LASER (K980142)Laserlite, LLC1998-04-03
XENON 300MX (K980044)Perkinelmer Optoelectronics1998-04-03
ULTIMA ACETABULAR ROOF REINFORCEMENT RING (K980286)Johnson & Johnson Professionals, Inc.1998-04-03
FUJI II (K980682)GC America, Inc.1998-04-03
BTI HUMERAL INTRAMEDULLARY ROD SYSTEM (K980102)Biodynamic Technologies, Inc.1998-04-03
SAFETY POWDERED BLUE LATEX EXAMINATION GLOVES (K980939)Besglove Medicare Sdn. Bhd.1998-04-03
DERMATHERM 100 (K980607)New Star Lasers, Inc.1998-04-03
PLAYTEX TAMPONS #03498 (K980478)Playtex, Inc.1998-04-03
BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS (K980819)Biocircuits Corp.1998-04-03
DEPUY ORTHOTECH PHANTOM SOF-THREAD SOFT TISSUE INTERFERENCE SCREW (K980440)Depuy, Inc.1998-04-03
SAFETY POWDERFREE BLUE LATEX EXAMINTION GLOVES (K980940)Besglove Medicare Sdn. Bhd.1998-04-03
PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS) (K980243)Parameter Developments, Inc.1998-04-03
OZ POWER SYRINGE (K973334)Cardiovascular Innovations1998-04-03
ACTIVELOCK MODULAR FEMORAL HIP SYSTEM (K980020)Metagen, LLC1998-04-03
WALLSTENT ENTERAL ENDOPROSTHESIS (K980113)Boston Scientific Scimed, Inc.1998-04-03
PARA-PAK SPINCON (K980077)Meridian Diagnostics, Inc.1998-04-02
B-D E ML PEN (K980755)Bd Becton Dickinson Vacutainer Systems Preanalytic1998-04-02
SILIMED NASAL RETAINER (K980221)Silimed, LLC1998-04-02
GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP (K980306)Elscint, Inc.1998-04-02
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Every clearance here is in the API, with alerts when new ones post.