Atlas FDA

1995

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

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RecordFirmDate
SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM (K943113)Aloka Co., Ltd.1995-02-01
SERIM(TM) BICARB PH REAGENT STRIPS (K945491)Serim Research Corp.1995-02-01
PEDIATRIC OSTEOTOMY SYSTEM (K945233)Howmedica Corp.1995-02-01
AVON SUNNY DAYS SUNGLASSES (K946092)Siegel,Mandell & Davidson,P.C.1995-01-31
NEUROLINK EEG/EP/EMG SURFACE ELECTRODES (K942921)Neuro Supplies, Inc.1995-01-31
RELAXOMAT (K925750)Relaxomat, Inc.1995-01-31
SPLIT TOP WING NEEDLE CAP WITH OPTIONAL TUBING ANCHORS (AND APPROPRIATE RECAP DEVICE (K944680)Researched, Novel Medical Devices (Rn/Md)1995-01-31
DRIED GRAM NEGATIVE/CEFMETAZOLE (K941317)Baxter Diagnostics, Inc.1995-01-31
CLAVE NEEDLE-LESS CONNECTOR OPEN EXTENSION SET (K941190)Icu Medical, Inc.1995-01-31
ALPHA STEREO (K934478)Instrumentarium Corp.1995-01-31
DURALASTIC SHEETING (K935571)Applied Biomaterial Technologies1995-01-31
TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER (K945382)Expertech Assoc., Inc.1995-01-31
ALL SILICONE INTERMITTENT CATHETER (K943851)Rochester Medical Corp.1995-01-31
SK S-RAY GRIDS (K945697)Seibu Techno Coproration1995-01-31
VITALMAX 800 PLUS/VITALMAX 810 PLUS/MINIPACK 300 (K945385)Pace Tech, Inc.1995-01-31
FI, GORDY TOY, WELLJOY AND OTHERS (K946004)Fundamental Industrial Co., Ltd.1995-01-31
URETHRAL SUTURE GUIDE (K950267)Applied Medical Resources1995-01-31
DURALASTIC SHEETING (K945552)Applied Biomaterial Technologies1995-01-31
AVON SUNNY DAYS SUNGLASSES (K946091)Siegel,Mandell & Davidson,P.C.1995-01-31
SAFE-1(TM) SYRINGE (K940635)Safety 1st Medical, Inc.1995-01-31
BNOS MICROVENT, MODEL AC AND MODEL AO (K944397)Racal Health & Safety, Inc.1995-01-31
BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS (K945995)Ximed/Prosure/Injectx1995-01-31
HIGH TEMPERATURE CAUTERY 5 LOOP (K945759)Aaron Medical Industries1995-01-30
OPHTHALMIC CAUTERY (K945493)Aaron Medical Industries1995-01-30
ALTERNATE 100% ETO STERILIZATION PROCESS AND ALTERNATE STERILIZATION FACCILITY (K950127)Medtronic Vascular1995-01-30
DLX (K945459)General Electric Co.1995-01-30
ADVANTX LCA (K945375)GE Medical Systems1995-01-30
HIGH TEMPERATURE CAUTERY (K945492)Aaron Medical Industries1995-01-30
HEWLETT-PACKARD MODEL M1490A WIRELESS PATIENT DATA COMMUNICATOR (K945277)Hewlett-Packard Co.1995-01-30
OTICON (K946045)Oticon, Inc.1995-01-30
SINGLE HANDED BREAST PUMP (K941112)Macneil Baby Care , Ltd.1995-01-30
INCARE HOT/ICE COLD THERAPY COOLER (K944971)Hollister, Inc.1995-01-30
OVAMED HSG CATHETER (K931122)Ovamed Corp.1995-01-30
MAICO IN-THE-EAR MODEL RD 201 (K946253)Maico Hearing Instruments, Inc.1995-01-30
CIBA CORNING 8-- SERIES CO-OXIMETER (K946206)Ciba Corning Diagnostics Corp.1995-01-30
CERTAIN(R) ELITE LEVEL 1, 2 AND 3 (K946224)Ciba Corning Diagnostics Corp.1995-01-30
VISUALINE II MORPHINE/OPIATES/HEROIN (K943248)Sun Biomedical Laboratories, Inc.1995-01-30
NEXT GENERATION KNEE SYSTEM (K933785)Zimmer, Inc.1995-01-30
GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES (K945676)Selectivemed Components, Inc.1995-01-30
CONDOM (K940045)Ansell, Inc.1995-01-30
PACIFIC COMMUNICATIONS MODEL 1100 (K942147)Accucore, Inc.1995-01-30
DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER (K943493)Hamilton Co.1995-01-30
UNITRON MODEL VISTA 1000 SIGMA, AIR CONDUCTION HEARING AID (K946323)Unitron Industries, Inc.1995-01-30
OSTEONICS(R) SERIES 7000 TOTAL KNEE (K940813)Osteonics Corp.1995-01-30
HIGH TEMPERATURE CAUTERY FINE ADJUSTABLE (K945757)Aaron Medical Industries1995-01-30
LX-ITC (K946071)Widex Hearing Aid Co., Inc.1995-01-30
MASSAGING HELMET C.F. HANSEN DESIGN (K940582)Philco Ushuaia1995-01-30
HIGH TEMPERATURE CAUTERY (K945765)Aaron Medical Industries1995-01-30
OGDEN ANCHOR ADDITIONAL APPLICATIONS (K935065)American Medical Electronics, Inc.1995-01-30
DSP OPTION (K945580)Philips Medical Systems (Cleveland), Inc.1995-01-30
DFS-700 (K945388)Shimadzu Corp.1995-01-30
ENDOXFLEX 5000 (K946239)Michael A Clark1995-01-30
HIGH TEMPERATURE CAUTERY (K945760)Aaron Medical Industries1995-01-30
HIGH TEMPERATURE CAUTERY ELONGATED FINE TIP (K945764)Aaron Medical Industries1995-01-30
PRISM MEDICAL CUSTOM DIALYSIS KIT (K941803)Medical Device Support Services1995-01-30
NON-LUBRICATED CONDOM (K940046)Ansell, Inc.1995-01-30
MAMMOCORE BIOPSY TRAY (K943653)Manan Medical Products, Inc.1995-01-30
INNOVATIVE SURGICAL(R) MANGUM KNOT PUSHER (K945394)Innovative Surgical, Inc.1995-01-27
AS/3 MEMORY MODULE, M0MEM (K945234)Datex Division Instrumentarium Corp.1995-01-27
EXTERNAL FIXATOR (K943857)Acu Med, Inc.1995-01-27
IMPLANTECH NASAL LABIAL IMPLANT (K943988)Implantech Associates, Inc.1995-01-27
STRATO MEDICAL INFUSE-A-PORT/INFUSE-A-KIT PERIPORT PERIPHERAL ACCESS SYSTEM (K934518)Strato Medical Corp.1995-01-27
SHARPS CONTAINER 18 GALLON (K944121)Bci, Inc.1995-01-27
3M(TM) EAR IMPRESSION MATERIAL (K945726)3M Medical Products Group1995-01-27
WGL ENDOSCOPIC GRASPER* (K950063)Wilson Greatbatch Technologies, Inc.1995-01-27
THERMASET (K946255)Ormco Corp.1995-01-27
BBL CRYSTAL MRSA ID SYSTEM (K941997)Becton Dickinson Microbiology Systems1995-01-27
RAPID YEAST PLUS SYSTEM (K943621)Innovative Diagnostic Systems, Inc.1995-01-27
CUSTOM MEDICAL SUSPENSION STRAP (K944988)Custom Medical Specialties, Inc.1995-01-27
APOLLO KNEE FEMORAL COMPONENT (K933229)Intermedics Orthopedics1995-01-27
HEMOCLIP ECOSYSTEM (K945520)Pilling Weck, Inc.1995-01-27
CONSENUS HIP SYSTEM -- ACETABULAR REAMER (K945186)U.S. Medical Products, Inc.1995-01-27
MODIFIED LUXAR LX-20 FAMILY C02 LASER SYSTEM (K945888)Luxar Corp.1995-01-27
TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION (K933995)Applied Osteo Systems, Inc.1995-01-27
KSEA STEINER ELECTROMECHANIC MORCELLATORT (K946213)KARL STORZ Endoscopy-America, Inc.1995-01-27
ENDOPATH(R) TRISTAR(TM) DISSECTOR AND TISSUE MANIPULATOR (K946241)Ethicon Endo-Surgery, Inc.1995-01-27
CONSENSUS HIP SYSTEM -- CALCAR PLANER (K945189)U.S. Medical Products, Inc.1995-01-27
DIDECO VACUUM PUMP (K936220)Dideco1995-01-27
PY30, PY60, PY80 (K944928)Huttinger Medizintechnik GmbH & CO KG1995-01-27
RAPIDVUE(TM) HCG (K945969)Quidel Corp.1995-01-27
CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER (K942546)Dynatech/Nevada, Inc.1995-01-27
ADVANCE(R) PREGNANCY TEST (K945846)Advanced Care Products1995-01-27
GLENROE ORTHO-SIL (K945535)Glenroe Technologies1995-01-27
PROLEX (STREPTOCCAL GROUPING LATEX KIT) (K934383)Pro-Lab, Inc.1995-01-27
TRIMLINE 2000 (K943081)Pymah Corp.1995-01-27
MASK, GAS, ANESTHETIC (K945894)Hans Rudolph, Inc.1995-01-27
SAFE VENT SYSTEM (K942394)Incutech, Inc.1995-01-27
FISONEB(R) II (K950206)Fisons Corp.1995-01-27
SELF-LATCHING CLIP (K945231)Surgical System, Inc.1995-01-27
ARGYLE SALEM SUMP TUBE ANTI-REFLUX VALVE INSERTION TRAY (K935781)Sherwood Medical Co.1995-01-27
DRAGER-VAPOR 19.1 (K942055)North American Grager1995-01-27
SORIN BLOOD CARDIOPLEGIA CONSOLE (K942582)Sorin Biomedical, Inc.1995-01-27
CHOLESTEROL QVET (K943027)Prisma Systems1995-01-27
M4 CONTRA-ANGLE HANDPIECE (K942480)Kerr Corporation (Danbury)1995-01-27
CONSENSUS HIP SYSTEM -- TROCHANTERIC CUTTER (K945208)U.S. Medical Products, Inc.1995-01-27
DEPUY AMK ALL POLYETHYLENE POSTERIOR STABLILIZED TIBIAL TRAY (K943299)Depuy, Inc.1995-01-27
CIT TWO WAY SUCTIN AND IRRIGATION TUBES (K944268)Chirurgische Instrumente1995-01-26
BIG PHIL (K946027)Biomedical Waste Systems, Inc.1995-01-26
HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH (K945248)Hukuba Dental Corp.1995-01-26
DISPOSABLE SYRINGES AND DISPOSABLE NEEDLES (K945225)Myco Medical Supplies, Inc.1995-01-26
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Every clearance here is in the API, with alerts when new ones post.