Atlas FDA

1996

4,407 FDA 510(k) clearances · Clearance year

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RecordFirmDate
PERMAMESH-D HYDROXYLAPATITE MATRIX (K960354)Ceramed Corp.1996-03-20
REMOVABLE HERBST APPLIANCE (K955822)Univ. Dental Assoc. Department of Orthodontics1996-03-20
PACE SAVER LITTLE JUNIOR (MODIFICATION) (K954974)Burke Mobility Products1996-03-19
QUANTA LITE PR3 (K955021)Inova Diagnostics, Inc.1996-03-19
BACTIDROP CALCOFLUOR WHITE (K960095)Remel Co.1996-03-19
EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES (K954105)Scimedx Corp.1996-03-19
SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE) (K936240)Sudormed, Inc.1996-03-19
SLOAN STA-DRI PANT PROTECTOR (K945302)Sloan Corp.1996-03-19
NON PRESCRIPTION SUN GLASSES (K960650)Solovision Optical, Inc.1996-03-19
VIVASPIN 4 10,000 MW (K960298)Vivascience, Inc.1996-03-19
SELFCARE EARLY PREGNANCY TEST (K960436)Selfcare, Inc.1996-03-19
DIGITAL IMAGING SYSTEM (K954159)Camtronics, Ltd.1996-03-19
T-3 MICROWELL EIA MODEL 7013 (K960412)Biomerica, Inc.1996-03-19
STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION (K940048)Solarcare Technologies Corp,Inc.1996-03-19
PLATFORM ONESTEP PREGNANCY HOME TEST (K960117)Syntron Bioresearch, Inc.1996-03-19
QUANTA LITE MPO (K955022)Inova Diagnostics, Inc.1996-03-19
EIA KIT FOR THE DETECTION OF ANTI-MPO ANTIBODIES (K954062)Scimedx Corp.1996-03-19
TRI-COURT 20-T (K960005)Hematronix, Inc.1996-03-19
CALCOFLUOR WHITE STAIN KIT (K960090)Remel Co.1996-03-19
O-PERM 30 A RIGID GAS PERMEABLE CONTACT LENS (K954124)Optical Polymer Research, Inc.1996-03-19
ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT (K955353)Tcpi, Inc.1996-03-19
TAS PTONE (K955843)Cardiovascular Diagnostic Services1996-03-18
PRIMIDONE EIA TEST (K960526)Diagnostic Reagents, Inc.1996-03-18
ZYMED HOLTER SCANNER MODEL 2010 (K955015)Zymed Medical Instrumentation1996-03-18
PRACTIFIX EXTERNAL FIXATION SYSTEM (K960014)Orthopaedic Innovations, Inc.1996-03-18
TRUPEAK PEAK FLOW METER (K955234)Monaghan Medical Corp.1996-03-18
KIRSHNER WIRES (K-WIRE) & STEINMANN PINS (K960023)Promex, Inc.1996-03-18
MICROAIR BY INVACARE MODEL APM ALTERNATING PRESSURE AIR FLOTATION MATRESS (K960411)Invacare Corp.1996-03-18
DFI-1000 AND DVS-475 IMAGING DEVICES (K951261)Nical1996-03-15
BLADDERSCAN BVI 5000 (K955942)Diagnostic Ultrasound Corp.1996-03-15
VARIS PORTALVISION (K955774)Varian Assoc., Inc.1996-03-15
ALPHA-DENT COMPOSITE SURFACE SEALANT (K960165)Wallace A. Erickson & Co.1996-03-15
DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVE (K960547)Espe GmbH & Co. Kg.1996-03-15
NIOMED SURGICAL CAPS (K955833)Amerasia Corp.1996-03-15
IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013 (K960480)Vident1996-03-15
KIS MT5 (K960112)The Implant Center of the Palm Beaches1996-03-15
LAURUS NEEDLE CORE BIOPSY SYSTEM (K960317)Laurus Medical Corp.1996-03-15
TETRAD 2300 E/U ULTRASOUNG IMAGING SYSTEM (K946277)Tetra Corp.1996-03-15
PROLEX MESH (K960219)Advanced Surgical Innovations, Inc.1996-03-15
OXLIFE OXYGEN CONCENTRATORS (K955549)Oxlife, Inc.1996-03-15
ENDOSSEOUS DENTAL IMPLANT & ACCESSORIES (K955281)The Straumann Co.1996-03-15
MAHLER ABDOMINAL WALL ELEVATOR (K960878)Cook Urological, Inc.1996-03-15
CADPLAN BT (K954467)Varian Assoc., Inc.1996-03-15
RT55 DIAGNOSTIC ULTRASOUND SYSTEM (K953752)General Electric Co.1996-03-15
PRE POWDERED LATEX EXAMINATION GLOVES (K954487)Ganz Industries Sdn. Bhd.1996-03-15
X-RAY VISIONS (K954172)Image Visions, LLC1996-03-15
NEXGEN COMPLETE KNEE SOLUTION 9MM ARTICULAR SURFACE (K951185)Zimmer, Inc.1996-03-15
DENTALOGIC (K960270)Protecs Syringes International Corp.1996-03-15
LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR (K953835)Dideco S.R.L.1996-03-15
FRIALIT(R)-2 STEPPED CYLINDER WITH FRIOS(R) TI-COATING (K945849)Friatec Medical Inc., USA1996-03-15
FRIALIT(R)-2 DENTAL IMPLANT (K945848)Friatec Medical Inc., USA1996-03-15
J.B. S. C1-C2 CLAMP (K955864)J.B.S., S.A.1996-03-15
CONSENSUS APEX DOME HOLE PLUG (K960340)U.S. Medical Products, Inc.1996-03-15
FLEXON TEMPORARY CARDIAC PACER LEAD (K955722)Davis & Geck, Inc.1996-03-15
FRIALIT(R)-2 STEPPED SCREW WITH DEEP PROFILE SURFACE (K945847)Friatec Medical Inc., USA1996-03-15
FEMRX OPERASTAR SYSTEM (K954648)Gynecare Innovation Center1996-03-14
G.E. STERILE AMNIOCENTESIS TRAY (K960203)GE Medical Systems1996-03-14
DOYLE EXTRACTOR (K955748)Safetech Intl., Inc.1996-03-14
DIGITAL CONDUCTANCE METER (K924313)The Jayms Co.1996-03-14
6.5 MHZ ENDORECTAL CONVEX ARRAY (10R) PROBE (K953773)Medison America, Inc.1996-03-14
DETECT CYTOLOGY BRUSH II (K960469)Cook Urological, Inc.1996-03-14
ECLIPSE PROBE COVER (K953673)Parker Laboratories, Inc.1996-03-14
VARICELISA, MODIFICATION (K943843)Biowhittaker Molecular Applications, Inc.1996-03-14
ALBUMIN (K955781)Derma Media Lab., Inc.1996-03-13
EBI ANTERIOR CERVICAL SPINE SYSTEM (K955730)Electro-Biology, Inc.1996-03-13
CALCIUM REAGENT (K955939)Derma Media Lab., Inc.1996-03-13
FREEMAN/SAMUELSON TOTAL KNEE SYSTEM (K943025)Biomet, Inc.1996-03-13
CLINICAL VITAL SIGNS MONITOR, MODEL #52STP-E1 (K951193)Tycos Instruments, Inc.1996-03-13
TIBIA ORTHONAIL (K955761)Orthologic Corp.1996-03-13
COORDINATE REVISION KNEE SYSTEM (K955884)Depuy, Inc.1996-03-13
TOTAL BILIRUBIN REAGENT (K955940)Derma Media Lab., Inc.1996-03-13
ALLDRESS MULTI LAYERED WOUND DRESSING (K955863)Molnlycke/Scott Health Care1996-03-13
SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED (K955680)Mallinckrodt Medical1996-03-13
AMAX CS-190 COAGULATION ANALYZER SYSTEM (K955720)Sigma Diagnostics, Inc.1996-03-13
HYDROLOGY 5000 (K955339)Northgate Technologies, Inc.1996-03-13
SPECTRUM DESIGNS SILICONE BLOCK (K960038)Spectrum Designs, Inc.1996-03-13
BRYAN POSTERIOR SPINAL FIXATOR (MODIFICATION) (K955927)Arcan Orthopaedic Corp.1996-03-13
PSA CONTROLS (K960154)Diagnostic Products Corp.1996-03-13
PERMARIDGE HYDROXYLAPATITE MATRIX (K960349)Ceramed Corp.1996-03-13
MEDRAD/HITACHI 1.5T QUAD C-SPINE SURFACE COIL (K954952)Medrad, Inc.1996-03-13
CPR EYE TRAY (K960242)Custom Pack Reliability1996-03-12
BEAUCOUP GENERAL PURPOSE DISINFECTANT (K960580)Huntington Laboratories, Inc.1996-03-12
VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) (K952095)Biomerieux Vitek, Inc.1996-03-12
RESOUND PERSONAL HEARING SYSTEM BT2-ES, BT2-EV, & BT241 (K960052)Resound Corp.1996-03-12
STERITEC CROSS-CHECKS (K955426)Steritec Products Mfg Co, Inc.1996-03-12
PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (K954415)Hartalega Sdn Bhd1996-03-12
YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY (K954006)Intl. Remote Imaging Systems1996-03-12
CATH-GUIDE (K955645)Hudson Respiratory Care, Inc.1996-03-12
HEMAGEN CRP 150 KIT (EIA METHOD) (K960324)Hemagen Diagnostics, Inc.1996-03-12
VOLMED OPERATION DRAPE (K955872)Medal Intl. Sales Co., LLC1996-03-12
DRYTIME FOR POTTY TRAINING (K955338)Health Sense Intl., Inc.1996-03-12
NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE (K955657)North State Plastics, Inc.1996-03-12
ASCEND GENERAL PURPOSE DISINFECTANT (K960582)Huntington Laboratories, Inc.1996-03-12
HYSTEROSCOPE (K954164)Conceptus, Inc.1996-03-12
KC 1A COAGULATION ANALYZER/SET (K955724)Sigma Diagnostics, Inc.1996-03-12
BATTERY POWERED ENDOSCCOPIC LIGHT SOURCE (K960081)Mitsubishi Cable America, Inc.1996-03-12
CREATININE REAGENT (K955938)Derma Media Lab., Inc.1996-03-12
SAS SALMONELLA 0 GROUP M FACTOR 28 ANTISERUM (K960160)Sa Scientific, Inc.1996-03-12
SAS SALMONELLA O GROUP Y FACTOR 48 ANTISERUM (K960129)Sa Scientific, Inc.1996-03-12
DIGISCOPE RX-2 (K960198)Medirex, Inc.1996-03-12
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Track 1996 automatically

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