Atlas FDA

1995

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

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RecordFirmDate
BICORE SMARTCATH INTRATRACHEAL CATHETER (K935788)Bicore Monitoring Systems1995-07-03
OGDEN ANCHOR FOR ALL ORTHOPAEDIC SOFT TISSUE APPLICATIONS (K951545)American Medical Electronics, Inc.1995-07-03
DIASTAT ANTI-THYROID PEROXIDASE KIT (K951487)Shield Diagnostics, Ltd.1995-06-30
COMPUSPEAK (K941566)Hogan & Hartson1995-06-30
GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM) (K950730)Phonic Ear, Inc.1995-06-30
MEDIPACS (K950413)Nexsys Electronics1995-06-30
LOK-ON NEEDLE DISPOSAL SYSTEM (K951886)Becton Dickinson Vacutainer Systems1995-06-30
SPECIFIC IGE ULTRA-EIA (K945884)Hycor Biomedical, Inc.1995-06-30
GIP/MEDI-GLOBE GUIDE WIRES & WIND-UP GUIDE WIRES (K941973)Medi-Globe Corp.1995-06-30
MPM HYDROGEL DRESSING (K952276)Mpm Medical., Inc.1995-06-30
CONTINUOUS EPIDURAL ANESTHESIA TRAY (K944029)Spinal Specialties, Inc.1995-06-30
SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS (K944219)Gish Biomedical, Inc.1995-06-30
TORCARS,CANNULAE,SHEATHS,OBTURATORS (K943713)Karl Storz Endoskop GmbH1995-06-30
HYDRAGEL PROTEIN(E) KIT (K951536)Sebia1995-06-30
ACURA-EX (K946232)Lustgarten Multi-Tech Intl.1995-06-30
TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY (K950533)Trophy Radiologie1995-06-30
TRANS-AIRE RIGID GAS PERMEABLE CONTACT LENS (K952165)Rand Scientific Corp.1995-06-30
K4 BONE SCREW SYSTEM (K950704)Kinetikos Medical, Inc.1995-06-30
FULL DYNAMIC RANGE COMPRESSION BEHIND THE EAR HEARING INSTRUMENT (K951828)Siemens Hearing Instruments, Inc.1995-06-30
BELTONE PETITE PLUS BELTONE PETITE PLUS CLEARVIOCE K (K951587)Beltone Electronics Corp.1995-06-30
GERTIE MARX EPI-SPINAL TRAY (K943319)Spinal Specialties, Inc.1995-06-30
SPINAL SPECIALTIES PENCIL-POINT SPINAL NEEDLE (K950820)Spinal Specialties, Inc.1995-06-30
ACUFEX ROTATOR CUFF FIXATION BUTTON (K941740)Acufex Microsurgical, Inc.1995-06-30
3I ASYST ABUTMENT PACKAGE SYSTEM (K951553)Implant Innovations, Inc.1995-06-30
FLEX D-4000 (K951419)U.S. Table, Inc.1995-06-30
COMBINATION CAMERA/LIGHT SOURCE (K951386)M.P. Video, Inc.1995-06-30
CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA (K950196)Bioclinical Systems, Inc.1995-06-30
ZIRCONIA ARTICUL/EZE FEMORAL BALLS (K952088)Depuy, Inc.1995-06-30
DIASTAT ANTI-THYROGLOBULIN KIT (K952183)Shield Diagnostics, Ltd.1995-06-30
MEDICAL IMAGING INFORMATION AND CAPTURE SYSTEM (MIICS) (K951175)Sirius Corp.1995-06-30
ENDO PROSTHESIS FEMORAL HEAD (K952461)Stelkast Company1995-06-30
AXSYM ULTRASENSITIVE HTSH II (K952148)Abbott Laboratories1995-06-29
GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A (K933934)Sigma Diagnostics, Inc.1995-06-29
FS-34P2, FIBER SIGMOIDOSCOPE (K951576)Pentax Precision Instrument Corp.1995-06-29
LABORATORY SHARPS BARREL (K950899)Biosystems1995-06-29
CEDIA FOLATE (NO BOIL) ASSAY (K951155)Microgenics Corp.1995-06-29
TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD (K951087)Pacesetter, Inc.1995-06-29
MODEL PV2000 VASCULAR MICROLABORATORY (K951486)Vasamedics, LLC1995-06-29
ENDO-BEND(TM) SHAVER (K950054)Paladin Medical, Inc.1995-06-29
T4 MICROWELL EIA (ENZYME IMMUNOASSAY0 (K950588)Biomerica, Inc.1995-06-29
SPACEMAKER, II SURGICAL BALLOON DISSECTOR WITH AND WITHOUT A CANNULA (K951878)General Surgical Innovations1995-06-29
AESCULAP BIOPOLAR COAGULATOR (K952524)Aesculap, Inc.1995-06-29
EUROPHILIC SLIPPERY COATED FOLEY CATHETER (K944007)Baxter Healthcare Corp1995-06-29
SYNCHRON ENZYME VALIDATOR SET (K951964)Beckman Instruments, Inc.1995-06-29
OMNI-JUG (K952200)Waterstone Medical, Inc.1995-06-29
GX-PAN PANORAMIC DENTAL X-RAY SYSTEM (K952598)Gendex Corp.1995-06-29
VECTOR(TM) AMBULATORY DRUG DELIVERY SYSTEM (K943591)Infusion Technology Intl.1995-06-28
DERMA SEAL (K952702)Ttl Medical1995-06-28
SENSICARE SYNTHETIC, SURGICAL GLOVE LINER (K950995)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-06-28
INTEC FULL FACE SHIELD (K946003)Intec Industries, Inc.1995-06-28
Kaplan-Simpson InfusaSleeve II Catheter (K952317)Localmed, Inc.1995-06-28
BELTONE COMPOSER 2000 (K950868)Beltone Electronics Corp.1995-06-28
TAMPER EVIDENT ARROWS WITH AND WITHOUT STERILIZATION INDICATORS (K951703)Products For Medicine1995-06-28
NON-WOVEN FILTER PAPER FOR STEAM AND GAS STERILIZATION (K951704)Products For Medicine1995-06-28
CAAS II (K945540)Pie Medical Equipment B.V.1995-06-28
VUTLER G.U.M. WITH FLUORIDE (K952091)John O. Butler Co.1995-06-28
PALCO LABS COLD POUCH (K942810)Palco Laboratories, Inc.1995-06-28
MED-TEC KNEE CRUTCH (K951717)Medtec, Inc.1995-06-28
PATIENT EXAMINATION GLOVE (K951940)Lowenkamp Intl., Inc.1995-06-28
HORTMANN AIRMATIC AIR CALORIC STIMULATOR (K950785)Jedmed Instrument Co.1995-06-28
OTOSONIC (OSI) CF 10-K, 10-D (K952097)Beltone Electronics Corp.1995-06-28
MEDISKIN(R) SS, ZENODERM BIOLOGICAL WOUND DRESSING (K950032)Brennen Medical, Inc.1995-06-28
BAZOOKA SYSTEM (K951469)Innovative Medical Systems, Inc.1995-06-28
QUINTON MODEL 710 STRESS ELECTROCARDIOGRAPH (K945626)Quinton, Inc.1995-06-28
NORTH BLOODBORNE PATHOGEN RESPONSE KIT (K950554)North Safety Products1995-06-28
3050 DIASCOPE NT PATIENT MONITOR (K942196)S & W Medico Teknik A/S1995-06-28
FC-38TLH, FIBER COLONOSCOPE (K951575)Pentax Precision Instrument Corp.1995-06-27
SIEMENS SC 9000 BEDSIDE MONITOR, SC 9015 BEDSIDE MOINTORING SYSTEM (K946306)Siemens Medical Solutions USA, Inc.1995-06-27
CHOLERA SMART(TM) (K932622)New Horizons Diagnostics Co.1995-06-27
SFC (K951303)Medpac1995-06-27
FLEXFINDER GUIDEWIRE (K943390)Flexmedics1995-06-27
MEDAMICUS PERCUTANEOUS INTRODUCER (K951313)Medamicus, Inc.1995-06-27
FLEXICAIR EXLIPSE (K951001)Hill-Rom, Inc.1995-06-27
FC-38LH, FIBER COLONOSCCOPE (K951580)Pentax Precision Instrument Corp.1995-06-27
DIDECO PEDIATRIC ARTERIAL FILTERS (K945198)Sorin Biomedical, Inc.1995-06-27
FS-38H, FIBER SIGMOIDOSCOPE (K951573)Pentax Precision Instrument Corp.1995-06-27
FS-38X, FIBER SIGMOIDOSCOPE (K951572)Pentax Precision Instrument Corp.1995-06-27
FC-38LX, FIBER COLONOSCOPE (K951578)Pentax Precision Instrument Corp.1995-06-27
VENTILATION MECHANICS MONITOR MODEL VMM-100 (K936156)Smith Industries Medical Systems (Sims)1995-06-27
PGS123 AND HVS-123 (K946299)Skylark Device Co., Ltd.1995-06-26
ROBERT B. SCOTT PLASTIC ARTIFICAL (K952538)Robert B. Scott Ocularists of Florida, Inc.1995-06-26
BIONECTOR (K941678)Vygon Corp.1995-06-26
SURGICAL DRAPE KIT (K933148)Nobelpharma USA, Inc.1995-06-26
MRINNERVU DISPOSABLE ENDORECTAL COLON COIL, CATALONG NO. PCC-15 (K952232)Medrad, Inc.1995-06-26
BOSTON CONTACT LENS CASE (K951552)Polymer Technology Corp.1995-06-26
OPTI PADS (K950940)Karlen Mfg., Inc.1995-06-26
SAFETEX SUPER HYPOALLERGENIC POWDERED LATEX EXAMINATION GLOVE (K952556)Aladan Corp.1995-06-26
SPINE TUNER POSTURE TRAINER (K951244)Dan Kline1995-06-26
RENALIN COLD STERILANT (K941439)Minntech Corp.1995-06-26
SUNGLASSES (K951815)Fung Won Optical Mfg. Co.1995-06-26
ANGIOSCAN (AS STAND ALONE INSTRUMENT) (K951132)Carl Zeiss Meditec, Inc.1995-06-26
MRIINNERVU DISPOSABLE ENDORECTAL CERVIC COIL, CATALOG NO. BCR-15 (K952235)Medrad, Inc.1995-06-26
MEMORYTRACE ATM MODEL 4222 (K941898)Hi-Tronics Designs, Inc.1995-06-26
MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES, SURGICAL INSTRUMENTS USED DURING ENDOSCOPIC PROCEDURES (K952290)Mist, Inc.1995-06-23
EW-10 AND EW-20 (K915402)Olympus Corp.1995-06-23
MUSCLESENSE ELECTROMYOGRAPHY DEVICE (K951350)Smith and Nephew Donjoy, Inc.1995-06-23
MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES (K952323)Mist, Inc.1995-06-23
V-CATH PERCUTANEOUS INTRODUCER KIT (K951384)Hdc Corp.1995-06-23
DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL (K952412)Dupont Medical Products1995-06-23
MODEM TRANSFER APPLICATION SOFTWARE NSMD-001A & NSMD-070A (K952484)Toshiba America Medical Systems, In.C1995-06-23
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Track 1995 automatically

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