Atlas FDA

1997

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

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RecordFirmDate
STERILE DISPOSABLE EQUIPMENT MAGNET COVER (K970185)Contour Fabricators, Inc.1997-04-10
TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE (K970370)Tsk Laboratory, Japan1997-04-10
IMMULITE THYROID AUTOANTIBODY CONTROL MODULE (K971051)Diagnostic Products Corp.1997-04-10
CARDIO TEAM II (K962937)Vision Electronics1997-04-10
ANCA SCREEN ELISA TEST SYSTEM (K964449)Zeus Scientific, Inc.1997-04-10
PROTEINASE-3 IGG ELISA TEST SYSTEM (K964448)Zeus Scientific, Inc.1997-04-10
FEMTEX 100% COTTON TAMPONS (K971228)Regu-Tech Assoc., Inc.1997-04-09
POINT-OF-CARE BLOOD GAS MONITOR SYSTEM (K961790)Optical Sensors, Inc.1997-04-09
INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER (K970492)Ackrad Laboratories1997-04-09
EBI SPINELINK SYSTEM (K964533)Electro-Biology, Inc.1997-04-09
3M RED DOT 2560 & 2570 MONITORING ELECTRODES (K970796)3M Healthcare1997-04-09
VENTRICULAR CATHETER BLOOD FLOW MONITORING PROBE KIT AND VENTRAFLO BLOOD FLOW MONITORING PROBE KIT (K962700)Vasamedics, LLC1997-04-09
MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III) (K970965)Midas Rex Pneumatic Tools, Inc.1997-04-09
PAP BRUSH (K963801)Young OU Brush Co.1997-04-09
SOMNUS MODEL 615 ELECTROSURGICAL GENERATOR(MODEL 615) (K970576)Somnus Medical Technologies, Inc.1997-04-09
OTOSILK OTOLOGICAL GRAFT DRESSING (K964534)Boston Medical Products, Inc.1997-04-09
RELIANCE PF FEMORAL STEMS (K970200)Howmedica Corp.1997-04-09
CARDIOISOZYME, CK/LD ISOENZYME CONTROL (K970856)Medical Analysis Systems, Inc.1997-04-08
CERTAIN COMPLETE LEVELS 1,2, AND 3; CVM LEVELS 1,2,3,4, AND 5 (K970956)Chiron Diagnostics Corp.1997-04-08
SPINALSCOPICS (K970862)Quantimetrix Corp.1997-04-08
IS-ANTI-JO-1 TEST SYSTEM (K970228)Diamedix Corp.1997-04-08
VIDAS C. DIFFICILE TOXIN A II ASSAY (K964887)Biomerieux Vitek, Inc.1997-04-08
E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET (K970259)Becton Dickinson Vascular Access, Inc.1997-04-08
NATURAL-HIP SYSTEM COCR REVISION STEM (K970166)Intermedics Orthopedics1997-04-08
IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER (K970227)Dpc Cirrus1997-04-08
NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT (K962208)Nichols Institute Diagnostics1997-04-08
IS-ANTI-SM TEST SYSTEM (K970220)Diamedix Corp.1997-04-08
IS-ANTI-SSA TEST SYSTEM (K970218)Diamedix Corp.1997-04-08
IS-ANTI-SM/RNP (720-270) (K970238)Diamedix Corp.1997-04-08
MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM (K964787)Mardx Diagnostics, Inc.1997-04-08
CLINISTRIP (K970250)Teco Diagnostics1997-04-08
ORGENTEC MICRO-ALBUMIN EIA ASSAY (K970932)American Laboratory Products Co., Ltd.1997-04-08
HYDROFLEX (K970656)GC America, Inc.1997-04-08
IS-ANTI-SSB TEST SYSTEM (720-260) (K970237)Diamedix Corp.1997-04-08
STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0) (K970921)Alko Diagnostic Corp.1997-04-08
MINIMED INSULIN PUMP, MODEL 505 (K963948)Medtronic Minimed1997-04-08
DOA-XSE, LIQUID DRUGS OF ABUSE CONTROL LEVELS 2,3, AND 4 (SDOA- 202,303,404) (K971058)Medical Analysis Systems, Inc.1997-04-08
SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR (K963755)Spiracle Technology1997-04-08
IS-ANTI-SCL-70 TEST SYSTEM (720-280) (K970239)Diamedix Corp.1997-04-08
IMMULITE COCAINE METABOLITE (K963918)Diagnostic Products Corp.1997-04-08
ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST (K970265)Drial Consultants, Inc.1997-04-08
DOWNSCAN 120 (K970451)Merlin Engineering Works, Inc.1997-04-07
RIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3000RPM/ROTARY BLADES AND ABRADERS SEE SECTION 1: (K970088)Richard Wolf Medical Instruments Corp.1997-04-07
LUMBAR PUNCTURE KIT (K970287)B.Braun Medical, Inc.1997-04-07
LASERSCOPE AUTOMATIC EYE PROTECTION FILTER (K970157)Laserscope1997-04-07
AESOP SYSTEM AND ACCESSORIES (K963126)Computer Motion, Inc.1997-04-07
SYSTEM B HEAT SOURCE (K970715)Sybron Dental Specialties, Inc.1997-04-07
IMEX FUTURALDOP PRO (K970156)Imex Medical Systems, Inc.1997-04-04
HEARTPORT ENDOAORTIC CLAMP (K964161)Heartport, Inc.1997-04-04
SHARPSITE AC (K965233)Xomed, Inc.1997-04-04
COMPUTED TOMOGRAPHY X-RAY SYSTEM (K970606)GE Medical Systems1997-04-04
SUPER-DENT ALGINATE,NORMAL SET, FAST SET,SUPER DELUXE DUSTLESS ALGINATE, NORMAL SET, DELUXE DUTLESS ALGINATE, FAST SET (K965083)S.S. White Mfg., Ltd.1997-04-04
CLINITEK HCG TEST STRIPS (K971209)Bayer Corp.1997-04-04
SYRINGEFILTER (K960928)Arbor Technologies, Inc.1997-04-04
TONOCAP, TC-200 AND ACCESSORY CATHETERS (K962638)Instrumentarium Corp.1997-04-04
PICTURE ARCHIVING & COMMUNICATIONS DEVICE (K970534)Multimedia Solutions1997-04-04
FLEXIBLE DILATING SHEATH (K945586)Med Institute, Inc.1997-04-04
KODAK EKTASIAN HG FILM (EHG-15) (K970154)Eastman Kodak Company1997-04-04
LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY (K963076)Louisville Laboratories, Inc.1997-04-04
VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101 (K964360)Novametrix Medical Systems, Inc.1997-04-04
EASY CAM (K970626)I.C.S.1997-04-04
CAVITRON JET WITH SPS SYSTEM (K970342)Dentsply Intl.1997-04-04
ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM (K970462)Acromed Corp.1997-04-03
PROCLEAR COMPATIBLES DAILY WEAR CONTACT LENS (K970095)Biocompatibles Eyewear, Inc.1997-04-03
HARMONIES MENSTRUAL TAMPON (K970108)Ecoprogress Intl.1997-04-03
KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD) (K970399)Allegiance Healthcare Corp.1997-04-03
ALOKA SSD-1700 DIAGNOSTIC ULTRASOUND SYSTEM (K963616)Aloka Co., Ltd.1997-04-03
URODYNAMIC ANALYSIS MODULE (K963330)Synectics Medical, Inc.1997-04-03
PERIFIX PEDIATRIC EPIDURAL KIT (K962696)B.Braun Medical, Inc.1997-04-03
ATLAS III ACETABULAR CUP (K961388)Fournitures Hospitalieres1997-04-03
COMPASS UNIVERSAL HINGE (K970713)Smith & Nephew, Inc., Orthopaedic Div.1997-04-03
ULTRATHERM (908) (K964083)Sie-Med, Inc.1997-04-03
CTS MIDCAB CORONARY SHUNT (K963503)Cardiothoracic Systems, Inc.1997-04-03
CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM (K962627)Siemens Medical Solutions USA, Inc.1997-04-03
12 URETEROSCOPES/URETERO-RENOSCOPES (K963855)Richard Wolf Medical Instruments Corp.1997-04-03
BIOMET BONE SCREW (K964970)Biomet, Inc.1997-04-03
STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D) (K970074)Hill-Rom, Inc.1997-04-03
REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK (K970830)Remel, Inc.1997-04-02
INTERLINK MICRO-INFUSION MANIFOLD EXTENSION SETS (K970438)Baxter Healthcare Corp1997-04-02
KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY (K961260)Biomet, Inc.1997-04-02
ALEXANDER MANUFACTURING COMPANY (K970271)Alexander Mfg. Co.1997-04-02
FOUNDATION KNEE SYSTEM TIBIAL COMPONENT (K970031)Encore Orthopedics, Inc.1997-04-02
THE ELECSYS CALCHECK PROGESTERONE (K970984)Boehringer Mannheim Corp.1997-04-02
SPACELABS MEDICAL INTEGRATED MULTI-PARAMETER MODULE (K952912)Spacelabs Medical, Inc.1997-04-02
MICS DEVICE SYSTEM (K963716)Percutaneous Technologies, Inc.1997-04-02
PRIMARY IV SET (K964435)Icu Medical, Inc.1997-04-02
MODEL 9500 MR-COMPATIBLE MULTIGAS MONITOR (K954120)Magnetic Resonance Equipment Corp.1997-04-02
INDOLE SWAB (K970833)Remel, Inc.1997-04-02
STONE DISLODGER, BASKET (K970121)Boston Scientific Corp1997-04-02
ACCUCURE 1000 (K970637)Lasermed, Inc.1997-04-02
BECTON DICKINSON BLUNT PLASTIC CANNULA (K964654)Bd Becton Dickinson Vacutainer Systems Preanalytic1997-04-02
DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900) (K970701)Diagnostic Systems Laboratories, Inc.1997-04-02
REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISK (K970831)Remel, Inc.1997-04-02
CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG (K964038)Heraeus Kulzer, Inc.1997-04-02
SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEM (K970733)Synthes (Usa)1997-04-02
STERITEC DRY HEAT INDICATOR LABEL (K953122)Steritec Products Mfg Co, Inc.1997-04-02
MAXCESS NEEDLEFREE - Y- SITE (100713) (K970800)Solopak Medical Products, Inc.1997-04-02
CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 (K970976)Medical Analysis Systems, Inc.1997-04-02
ESG-1 ELECTROSONOGRAM (ESG-1) (K970116)Myo-Tronics, Inc.1997-04-02
KEELER SPECTRA INDIRECT OPHTHALMOSCOPE (K970029)Keeler Instruments, Inc.1997-04-02
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Every clearance here is in the API, with alerts when new ones post.