Atlas FDA

1992

3,665 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ROTOLUX, SELECTOLUX, SHUTTERVUE (K922079)American Medical Sales, Inc.1992-06-16
PROLONGED OCCLUSION DRESSING II (K920874)Ferndal Laboratories1992-06-16
MIL CM-II COAGULATION MACHINE (K913320)Medical Innovations Corp.1992-06-16
CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE (K921148)Cardiovascular Imaging Systems, Inc.1992-06-16
IL TEST IMMUNOGLOBULIN A (K920014)Instrumentation Laboratory CO1992-06-16
SHOWERFLOSS ORAL IRRIGATION UNIT (K922307)Showerfloss, Inc.1992-06-16
BITE RIM WAX (K922380)Dentsply Intl.1992-06-16
IL TEST COMPLEMENT 3 (K920007)Instrumentation Laboratory CO1992-06-16
PROLONGED OCCLUSION DRESSING I (K920875)Ferndal Laboratories1992-06-16
ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE (K921601)Ultradent Products, Inc.1992-06-16
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (K921746)Biomerieux Vitek, Inc.1992-06-16
ROCHE CALIBRATOR SERUM (K922043)Roche Diagnostic Systems, Inc.1992-06-16
CEDIA RED BLOOD CELL FOLATE REAGENT PACK (K921689)Microgenics Corp.1992-06-16
RENAMEL ESTHETIC RESTORATIVE SYSTEM, MODIFICATION (K921820)Cosmedent, Inc.1992-06-16
OMNIMED HOLMIUM LASER AND DELIVERY SYSTEM (K915651)Summit Technology, Inc.1992-06-15
LPI ML 100/532 AND ML 532 SURGICAL LASER (K915631)Laser Photonics, Inc.1992-06-15
TECH DYNE - HP-2000, SKREEN TEST, RMS-200 (K920183)Tech Dyne Group1992-06-15
ND;YAG SURGICAL LASER SYSTEMS (K915578)Heraeus Lasersonics, Inc.1992-06-15
VIVUS 50 AND VIVUS 100 PERSONAL INFUSER (K915646)I-Flow Corp.1992-06-15
VISTA HP/HPQ SYSTEM (K921609)Philips Medical Systems (Cleveland), Inc.1992-06-15
AUTOMATES COMA COCAINE METABOLITE ASSAY (K921834)Serex, Inc.1992-06-15
PATIENT EXAMINATION GLOVES (K921376)Seal Polymer Industries Bhd.1992-06-15
CUSA SYSTEM 200C AND 200T ULTRASONIC ASPIRATOR (K921251)Valleylab, Inc.1992-06-12
TROCAR SHEATH ANCHOR (K915116)Origin Medsystems, Inc.1992-06-12
OLYMPIC SMART SCALE CARE CENTER (K920423)Olympic Medical Corp.1992-06-11
NASOPHARYNGEAL AIRWAY (K921353)Coast Medical Corp.1992-06-11
MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE (K922227)Cardiotronics, Inc.1992-06-11
MODEL # 230 ST STEALTH-TRODE DEFIB PADS (STERILE) (K922172)Cardiotronics, Inc.1992-06-11
OPHTHALMIC PROJECTOR (K921214)Luneau Ophtalmologie SA1992-06-11
X-330/SPIRIT MOTORIZED THREE-WHEELED SCOOTER (K922338)Am Scooters1992-06-11
JACE KNEE EXTENSION SYSTEM -- MODIFICATION (K922185)Jace Systems, Inc.1992-06-11
MODEL # 830 ST ADULT STIMULATION PADS (STERILE) (K922173)Cardiotronics, Inc.1992-06-11
MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION (K913817)Synectics-Dantec1992-06-11
BEAR 7 VENTILATOR (K912619)Bear Medical Systems, Inc.1992-06-11
ORTHO-PLEX-REHABILITATION SYSTEM (K920686)Plexus Intl., Inc.1992-06-11
GAS SAMPLING KIT MODIFICATION (K921510)Respiratory Support Products, Inc.1992-06-11
KNEE PROSTHESIS DRIVER (K915776)Kim-Med, Inc.1992-06-11
AUTO SUTURE(R) ARTICULATING ENDOSCOPIC CLAMP (K914753)United States Surgical, A Division of Tyco Healthc1992-06-11
INFRASONICS VENTILATOR ADULT STAR, MODIFICATION (K911804)Infrasonics Corp.1992-06-11
MICRO-COLL COLLAGEN WOUND SPRAY (K912565)Micro-Coll1992-06-11
MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM (K912904)Mentor O & O, Inc.1992-06-11
GRIESHABER SNARE INSTRUMENT AND SNARE CARTRIDGE (K914588)Grieshaber & Co.1992-06-11
CRITICAL CARE HOSPITAL BED (ICU/CCU) (K915437)Hill-Rom, Inc.1992-06-11
AUTO SUTURE(R) ARTICULATING ENDOSCOPIC SCISSORS (K914752)United States Surgical, A Division of Tyco Healthc1992-06-11
NEOPROBE PORTABLE RADIOSCOPE DETECTOR (K915279)Neoprobe Corp.1992-06-10
IN THE EAR HEARING AID (K915711)Zenith-Omni H.C., Inc.1992-06-10
MORSE HEMOSTATIC CATHETER INTRODUCER SET (K915078)North American Instrument Corp.1992-06-10
BELTONE OPERA CLEARVOICE IC, ITC (IN THE CANAL) (K922301)Beltone Electronics Corp.1992-06-10
UD 2000 VIDEO OPTION (K915342)Diagnostic Ultrasound Corp.1992-06-10
JANUS ATAC ENG ANALYSIS SYSTEM (K904385)Life-Tech Intl., Inc.1992-06-10
ELECTROENCEPHALOGRAPH RECORDING SYSTEM (K920127)Medelec Intl. Corp.1992-06-10
CHEM CHEX THEOPHYLLINE CONTROL (K920223)Streck Laboratories, Inc.1992-06-10
PROGRAMMABLE HEARING SYSTEM, ITE AND BTE TYPES (K922422)Audioscience, Inc.1992-06-10
SHIMADZU IMAGE AMPLIFIER IA-12VMA SERIES (K922013)Shimadzu Medical Systems1992-06-10
SHIMADZU IMAGE AMPLIFIER IA-12VDA SERIES (K922011)Shimadzu Medical Systems1992-06-10
SONY LASER VIDEODISC RECORDING SYSTEM (K921275)Sony Medical Systems1992-06-10
PCA TOTAL HIP SYSTEM (CEMENTLESS USE) (K920831)Pfizer Hospital Products Group, Inc.1992-06-10
4 SURE TM COLOSTOMY POUCH (K922401)Boston Pacific Medical, Inc.1992-06-10
OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER (K920942)Olympus Corp.1992-06-10
SPECTRA ECG (K915658)Advanced Medical Products, Inc.1992-06-10
ORS-100 (K921568)Mnlase, Inc.1992-06-09
BACTIDROP INDIA INK (K920976)Remel Co.1992-06-09
BACTIDROP CALCOFLUOR WHITE (K920975)Remel Co.1992-06-09
DURAFILL BOND (K921701)Heraeus Kulzer, Inc.1992-06-09
OPTISOL CORNEAL STORAGE MEDIA CONTAINER/MODIFIED (K921729)Chiron Intraoptics1992-06-09
ACCESS QD HEAD COIL (K920098)Toshiba America Mri, Inc.1992-06-09
CIBA CORNING ACS FOLATE IMMUNOASSAY (K921678)Ciba Corning Diagnostics Corp.1992-06-09
HERMLE Z230H (K920207)Labnet Intl., Inc.1992-06-09
LIQUICHEK LIPIDS CONTROL LEVELS 1 AND 2 (K921286)Bio-Rad1992-06-09
INVALIFT (K910830)American Invalift Corp.1992-06-09
CASCADE 480 (K921363)Helena Laboratories1992-06-09
IMED MODEL PC-4 VOLUMETRIC INFUSION PUMP/CONTROLLE (K921378)Imed Corp.1992-06-09
IMMULITE(R) FSH (K921704)Cirrus Diagnostics, Inc.1992-06-09
TB SUSCEPTIBILITY QUADS I AND II (K920143)Remel Co.1992-06-09
THROMBO-CALIBRATOR KIT (K921344)American Bioproducts Co.1992-06-09
AVK CONTROL I & II (K921665)American Bioproducts Co.1992-06-09
VALTRAC(R) INTRODUCER FORCEP (K922348)American Cyanamid Co.1992-06-09
TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY (K921763)Hybritech, Inc.1992-06-09
GLYCO-TEK AFFINITY COLUMN KIT (K921305)Helena Laboratories1992-06-09
DURA MATER (K910447)Lifelink Foundation Tissue Bank1992-06-09
ORS-200 (K921569)Mnlase, Inc.1992-06-09
STERILE/SINGLE USE OPHTHALMIC CONFORMERS (K921229)Storz Instrument Co.1992-06-09
.10' HI-TORQUE FLOPPY, INTER. & STAND. GUIDE WIRE (K915723)Advanced Cardiovascular Systems, Inc.1992-06-09
SNOWDEN-PENCER IRRIGATION PUMP (K920985)Snowden-Pencer1992-06-09
SCIMED(R) CONTROLWIRE(TM) GUIDE WIRE (K914194)Scimed Life Systems, Inc.1992-06-09
PTT-LA TEST KIT (K921684)American Bioproducts Co.1992-06-09
KEANE UNI KNEE SYSTEM WITH POROCOAT (K921232)Depuy, Inc.1992-06-09
DEXSOL CORNEAL STORAGE MEDIA CONTAINER, MODIFIED (K921728)Chiron Intraoptics1992-06-09
BACTIDROP KOH (10%) (K920970)Remel Co.1992-06-09
QUICKANCHOR, MODIFICATION (K921873)Mitek Surgical Products, Inc.1992-06-09
SEROELISA(TM) CHLAMYDIA IGA TEST KIT (K914327)Savyon Diagnostics , Ltd.1992-06-09
UNICALIBRATOR KIT (K922021)American Bioproducts Co.1992-06-09
ORS-300 (K921570)Mnlase, Inc.1992-06-09
OMNIFLEX M-HA HIP STEM SERIES (K920193)Stryker Corp.1992-06-08
SHARPLAN CO2 SURG. LASER, MO. 1039 SURGICENTER 40 (K921146)Sharplan Lasers, Inc.1992-06-08
CKS OSCILLATING SAW BLADE (K921131)Techmedica, Inc.1992-06-08
THERMAL PROBE COVER (K915831)Vermont Medical, Inc.1992-06-08
OMNIFIT M-HA HIP STEM SERIES (K920231)Stryker Corp.1992-06-08
R-GROUP INTL. ONE WALL PUNCTURE NEEDLE (K913267)R-Group Intl.1992-06-05
PAPILLION PROCTOSCOPE (K914784)Oldelft Corp. of America1992-06-05
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