Atlas FDA

1996

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

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RecordFirmDate
ELECSYS CALCHECK FT4 (K963164)Boehringer Mannheim Corp.1996-08-27
CPR TRACHEOTOMY CARE TRAY (K960205)Custom Pack Reliability1996-08-27
AIRPERM(SIFLUFOCON A) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENSES FOR DAILY WEAR (K962934)Airperm, Inc.1996-08-27
RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER (K962472)Rusch Intl.1996-08-27
CEDIA PROCAINAMIDE ASSAY (K962099)Boehringer Mannheim Corp.1996-08-27
QUADRATURE AND PHASED ARRAY FLEXIBLE BODY COILS (K962117)Philips Medical Systems (Cleveland), Inc.1996-08-27
PHOENIX CRX VALVE (K960435)Phoenix Biomedical Corp.1996-08-27
DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05 (K955880)Diagnostic Chemicals , Ltd.1996-08-27
STATAK SOFT TISSUE ATTACHMENT DEVICE (K962397)Zimmer, Inc.1996-08-27
CARBOMEDICS HANDLE (K962154)Carbomedics, Inc.1996-08-27
ELECSYS CALCHECK FT3 (K963163)Boehringer Mannheim Corp.1996-08-27
POSTERIOR ANNULOPLASTY BAND (MODEL 607) (K960356)The Heart Valve Div. Medtronic Cardiovascular Surg1996-08-27
ELECSYS CALCHECK T4 (K963178)Boehringer Mannheim Corp.1996-08-27
IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25 (K961587)Diagnostic Chemicals , Ltd.1996-08-27
ELECYS CALCHECK T 3 (K963167)Boehringer Mannheim Corp.1996-08-27
KSEA BIPOLAR GOAGULATING FORCEPS (K962396)KARL STORZ Endoscopy-America, Inc.1996-08-27
BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD (K960424)Endotec, Inc.1996-08-26
ACRYLIC READING AND POLYCARBONATE LENSES SUNGLASSES (K962279)Jane Fui Optical Co., Ltd.1996-08-26
LIGHT COMMANDER (K960767)Scieran Technologies, Inc.1996-08-26
DYNATRON 125 ULTRASOUND (K961250)Dynatronics Corp.1996-08-26
RAVEN EYE- EYE WEAR (SUNGLASSES) (K963284)Raven Eye, Inc.1996-08-26
RAVEN EYE, INC.- EYE WEAR (K962940)Raven Eye, Inc.1996-08-26
HORIZON/WESTHIN 55-G (K962121)Westcon Contact Lens Co., Inc.1996-08-26
SALTER LABS 8990 SERIES NEBULIZER (K962085)Salter Labs1996-08-26
LINEA MILANO SUNGLASSES, KALEIDO SUNGLASSES PLASTIC AND METAL FRAMES (K963083)Piazza Optical Corp.1996-08-26
MODEL 1200 ABMULATORY INFUSION PUMP (K961263)Patient Solutions, Inc.1996-08-23
COMPRESSION SCREW (K962779)Orthopaedic Biosystems, Ltd.1996-08-23
ELECSYS CALCHECK TROPONIN T (K963143)Boehringer Mannheim Corp.1996-08-23
NEXGEN KNEE PROSTHESIS & LEGACY KNEE PROSTHESIS W/CO-NIDIUM SURFACE HARDENING PROCESS (K962196)Zimmer, Inc.1996-08-23
HUA-XIA ACUPUNCTURE NEEDLES (K962916)Lhasa Medical, Inc.1996-08-23
ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA (K962875)Diagnostic Systems Laboratories, Inc.1996-08-23
MEDLINE PRE-POWDERED NON-STERILE AND STERILE LATEX EXAMINATION GLOVES (K962094)Medline Industries, Inc.1996-08-23
ASPECT OPTICAM (K962051)Aspect Electronics, Inc.1996-08-23
RETICULOCYTE METHOD, RBC INDICES (K954594)Bayer Corp.1996-08-23
STERITEC DISPOSABLE BIOLOGICAL TEST PACK (K961721)Steritec Products Mfg Co, Inc.1996-08-23
ITO ACUPUNCTURE NEEDLES (K963194)Oms Medical Supplies, Inc.1996-08-23
OPUS HLH (K962866)Behring Diagnostics, Inc.1996-08-23
HEMOCUE B-GLUCOSE SYSTEM (K961311)Hemocue, Inc.1996-08-23
EQUIPMENT COVERS (K961699)United States Surgical, A Division of Tyco Healthc1996-08-23
MEDLINE POWDER-FREE NON-STERILE LATEX EXAMINATION GLOVES,MEDLINE POWDER-FREE STERILE LATEX EXAMINATION GLOVES (K962095)Medline Industries, Inc.1996-08-23
AXSYM TOXO IGM (K954576)Abbott Laboratories1996-08-23
SUNQUEST INTERNATIONAL (K963059)Sunquest Intl., Inc.1996-08-23
ELECSYS CALCHECK CK-MB (K963182)Boehringer Mannheim Corp.1996-08-23
ELECSYS CALCHECK TSH (K963147)Boehringer Mannheim Corp.1996-08-23
CADD-PRIZM MODEL 6100 PUMP (K960826)Sims Deltec, Inc.1996-08-23
MEDLINE PWDER-FREE VIBNYL EXAMIUNATION GLOVES/VINYL GLOVES, STERILE (MDS 192074,5,6) (K962076)Medline Industries, Inc.1996-08-23
BENZ 38 CLEAR & WITH BLUE VISIBILITY TINT (K961103)Benz Research and Development Corp.1996-08-23
OREX SURGEON'S VEST (K961083)Thantex Specialties, Inc.1996-08-23
NOVA CHEMISTRY CONTROLS, LEVEL 1,2,AND 3 W/O CREAT (K962982)Nova Biomedical Corp.1996-08-23
RPS-50 BEAM SCANNER (K962080)Sofield Science Services, Inc.1996-08-23
SCRIPPS LABORATORIES HCG ONE-STEP (K962906)Scripps Laboratories, Inc.1996-08-23
STORZ D4600 AIR EXCHANGE LINE PACK (K962131)Storz Instrument Co.1996-08-23
NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE) (K963005)Nova Biomedical Corp.1996-08-23
FITO DIDO (K963075)Framesmart, Inc.1996-08-22
MEDTRONIC MODEL 5058 BIPOLAR, IMPLANTABLE, SCREW-IN, VENTRICULAR/ATRIAL, TRANSVENOUS LEAD (K962036)Medtronic Vascular1996-08-22
KARL STORZ INST. FOR ENDOSCOPIC SELECTIVE PERF. VEIN DISCISSION & PARATIBIAL FASCIOTOMY (K960903)KARL STORZ Endoscopy-America, Inc.1996-08-22
WEEKS APPLICATOR (K951052)Duke University Medical Center1996-08-22
VARIOUS DENTAL IMPLANTS WITH COVER SCREWS (K961861)Implant Management of America1996-08-22
MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT (K962013)Mentor Corp.1996-08-22
GILL-THOMAS-COSMAN(GTC) DENTAL TRAY (K962155)Radionics Software Applications, Inc.1996-08-22
KODAK DIGITAL SCIENCE FILM DIGITIZER L7501/L7506 (WITH FILM AUTOFEEDER) (K961768)Kodak Health Imaging Systems, Inc.1996-08-22
GENIE (K961843)Burton Medical Products Corp.1996-08-22
A-DEC SELF-CONTAINED WATER SYSTEM (K962665)A-Dec, Inc.1996-08-22
SONOSCAN (K961692)Sonotech, Inc.1996-08-22
MARCELLA CARAN (K962912)Framesmart, Inc.1996-08-22
BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER (K962103)Bio-Logic Systems Corp.1996-08-22
GORE SPHEREX IMPLANT (K962241)W. L. Gore & Associates, Inc.1996-08-22
STRYKER KNIFELIGHT (K961122)Stryker Instruments1996-08-22
ARTHRO-SURGIMAT (K962114)W.O.M. World of Medicine GmbH1996-08-22
THE ROBOGUIDE (K961849)Shai Syg Motion and Innovations, Ltd.1996-08-21
SHARPLAN LASERS, INC. AF ACUSPOT MICROMANIPULATOR (713) (K962974)Sharplan Lasers, Inc.1996-08-21
BBL MGIT PRODUCTS (K954932)Becton Dickinson Diagnostic Instrument Systems1996-08-21
3M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AUTOMATIC FILM PROCESSOR (K962750)Imation Corp.1996-08-21
PRONEB TURBO COMPRESSOR MODEL 38V0200 (K962072)Pari Holding Co.1996-08-21
MUREX RUB-EX (K954920)Murex Diagnostics, Inc.1996-08-21
ETHICAL HEARING INSTRUMENTS/WIZARD HEARING PROFILE TESTER (K962012)Ethical Hearing Instruments1996-08-21
LASERSONICS ND:YAG CYLINDRICALLY DIFFUSING STERILE DISPOSABLE FIBER (K960636)Heraeus Surgical, Inc.1996-08-21
IMMAGE IMMUNOCHEMISTRY SYSTEM (K962294)Beckman Instruments, Inc.1996-08-21
CARDIOCATH CATHETERIZATION LAB SYSTEM (K960321)Prucka Engineering, Inc.1996-08-21
DIALYSIS MIXING & HOLDING TANK (K961416)Dial Medical Supply1996-08-21
BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07) (K962174)Intermedics, Inc.1996-08-21
BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS (K961792)Biocircuits Corp.1996-08-21
OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (ENT) (K962485)Olympus America, Inc.1996-08-20
OLYMPUS B5-2C/B7-2C BALLOON CATHETER (K962901)Olympus America, Inc.1996-08-20
STRYKER ORAL MAX SYSTEM (K954690)Stryker Corp.1996-08-20
UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY (K963116)Diagnostic Chemicals , Ltd.1996-08-20
POWDERFREE BLUE LATEX EXAM GLOVES WITH PROTEIN CONTENT LABELING CLAIM (K953958)Codan Medlon, Inc.1996-08-20
BLUE LATEX EXAM GLOVES WITH PROTEIN CONTENT LABELING CLAIM (K953956)Codan Medlon, Inc.1996-08-20
ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC) (K951853)Tcpi, Inc.1996-08-20
EP-X BIPLANE (K961207)Fischer Imaging Corp.1996-08-20
TALKING DIGITAL THERMOMETER (K962369)Ultmost Industrial Corp.1996-08-20
PERMARIDGE SYRINGE (K962838)Ceramed Corp.1996-08-20
SENSOR SHEATH TS1 (K962386)Radiotherapeutics Corp.1996-08-20
POWDERFREE LATEX EXAM GLOVES WITH PROTEIN CONTENT LABELING CLAIM (K953955)Codan Medlon, Inc.1996-08-20
LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III (K963085)International Enzymes, Inc.1996-08-20
UROTAC BONE ANCHOR INSERTER (K962372)Influence, Inc.1996-08-19
RADWORKS MEDICAL IMAGING SOFTWARE (K962699)Applicare Medical Imaging, B.V.1996-08-19
CROSS-CHECKS (K951113)Steritec Products Mfg Co, Inc.1996-08-19
TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY (K961573)Hybritech, Inc.1996-08-19
INTERFERENCE SCREW (K960962)Linvatec Corp.1996-08-19
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Track 1996 automatically

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