Atlas FDA

1995

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

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RecordFirmDate
DI-2000 (K943602)Miles Inc., Agfa Division1995-05-12
CHAMPION (K950815)Kleinfeld, Kaplan and Becker1995-05-12
IMWXDOP IR (K944196)Imex Medical Systems, Inc.1995-05-12
RESOUND ED4-M MINI-CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (RESOUND PHS ED4-M) (K951068)Resound Corp.1995-05-12
CRYSTAL (K951168)Crystal Optical Co., Ltd.1995-05-12
MICRO MULTILEAF COLLIMATOR (K943714)Leibinger F.L. Fischer1995-05-12
AVANTGARDE (K951847)Otto Bock Orthopedic Industry, Inc.1995-05-12
DISPOSABLE AUDIOMETER EARPHONE CUSHION COVER (K943215)Kenneth Ullrich1995-05-12
DISOPOSABLE & RESUABLE MONPOLAR CORD (K951912)Boston Surgical Products, Inc.1995-05-12
PROSYS URIHESIVE SYSTEM LA (K951530)Convatec, A Division of E.R. Squibb & Sons1995-05-12
RYDER CONTACT LENS CASE (K951181)Bradstreet Clinical Research Assoc., Inc.1995-05-12
RESOUND ED4-C CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (RESOUND PHS ED4-C) (K951067)Resound Corp.1995-05-12
AMERICAN DENTAL PRODUCTS (ADP), VISIBLE LIGHT CURE COMPOSITE DENTAL RESTORATIVE MATERIAL (K951426)American Dental Products, Inc.1995-05-12
ECG MONITOR (K944262)Fukuda Denshi USA, Inc.1995-05-12
ALL-IN-ONE TWO CHAMBER CONTAINER (K945193)Baxter Healthcare Corp1995-05-12
MECHANICAL WHEELCHAIR- CHALLENGER (K945149)Colours 'N Motion1995-05-12
HEMA-GLU (K951220)Health-Dent Intl., Inc.1995-05-12
ENDO IRRIGATOR 2211, INCLUDING TUBING (K951715)Richard Wolf Medical Instruments Corp.1995-05-12
MECHANICAL WHEELCHAIR- AVENGER (K945148)Colours 'N Motion1995-05-12
FMS HIGH FLOW ARTHRO-SHEATH (K951702)Future Medical Systems, Inc.1995-05-12
MECHANICAL WHEELCHAIR- G-FORCE (K945151)Colours 'N Motion1995-05-12
CMS SYSTEM (K922528)Micromedical Industries, Ltd.1995-05-12
SIMULIX-HP (K946128)Oldelft Corp. of America1995-05-12
OPERAND* ULTRASOUND TRANSMISSION GEL (K951695)Redi Products, Inc.1995-05-12
INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP: (K950658)Innerdyne, Inc.1995-05-12
MINI IMAGER (K950423)Regulatory Management Services1995-05-12
MECHANICAL WHEELCHAIR- LIL DIPPER (K945153)Colours 'N Motion1995-05-12
DANEK RIGID ARTHROSCOPE (K950501)Sofamor Danek USA,Inc.1995-05-12
INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP (K950632)Innerdyne, Inc.1995-05-12
RELACS 7000 (K951272)Micro-Mega Societe Anonyme1995-05-12
TREBAY IRRGATED CUTTER BLADE (K951526)Trebay Medical Corp.1995-05-12
KSEA DISPOSABLE TUBING SET FOR THE ARTHROPUMP (K950561)KARL STORZ Endoscopy-America, Inc.1995-05-12
MRH-1500 (K943798)Hitachi Medical Systems America, Inc.1995-05-12
MECHANICAL WHEELCHAIR 890.3850 (K945175)Lumex, Inc.1995-05-12
HYDROGEL DRESSING (K945217)O.R. Resources, Inc.1995-05-12
OTI MODEL 78-60 (K951184)Oti Medical, LLC1995-05-12
NELLCOR SYMPHONY PULSE OXIMETER MODEL N-3000 (K942347)Nellcor, Inc.1995-05-12
MIST ENDOSCOPIC NEEDLES (K951648)Mist, Inc.1995-05-12
NON-CONTACT TONOMETER T-2 (K943939)Canon, Inc.1995-05-12
TETRAD MODEL BG22, AUTOMATIC BIOPSY UNIT MODEL (K945320)Tetra Corp.1995-05-11
KARL STORZ ENDOVISION TWINVIDEO (DIGITAL PICTURE-IN-PICTURE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENS (K950975)Karl Storz Imaging, Inc.1995-05-11
LYFO(TM) DIFFERENTIAL DISK (K945488)Microbiologics, Inc.1995-05-11
OP-PNEU ELECTRONIC CO2 (K941438)Wisap/U.S.A.1995-05-11
SERIES 6600 DIGITAL MOBILE C-ARM (K951765)Ge Dec Medical Systems1995-05-11
LYFO(TM) DIFFERENTIAL DISK (K945489)Microbiologics, Inc.1995-05-11
THERMAFLEX, MODEL SD 55 C.P.M.H. (K945803)Burke Neutech, Inc.1995-05-11
LYFO(TM) DIFFERENTIAL DISK (K945487)Microbiologics, Inc.1995-05-11
BABYCARE NEO2 OXYGEN CONCENTRATION CONTROLLER (K943797)Bpr Medical, Ltd.1995-05-11
PS II (K943513)Washington Biotechnology1995-05-11
R 302 (K946320)Ralco S.R.L.1995-05-11
MED-TEC STRING RETICLE TRAY (K951601)Medtec, Inc.1995-05-11
AMSINO DISPOSABLE VIGINAL SPECULUM (K951528)Amsino Intl., Inc.1995-05-11
ETHICON DRILL BIT AND DRILL GUIDE (K944590)ETHICON, Inc.1995-05-11
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM (K950973)GE Medical Systems1995-05-11
FST FIBEROPTIC PRESSURE CONVERTER (K945753)Fiberoptic Sensor Technlogies, Inc.1995-05-11
COOK INSEMINATION CUP (K950714)Cook Urological, Inc.1995-05-11
METEL URETERAL BASKET STONE DISLODGER (K951761)Annex Medical, Inc.1995-05-11
INCONTROL (K935213)Thought Technology , Ltd.1995-05-11
KARL STORZ DILATION SET, REDUCERS, THREAD SLEEVES, DISTANCE HOLDERS (K946359)KARL STORZ Endoscopy-America, Inc.1995-05-11
SHIMADZU IMAGE AMPLIFIER IA-12LM SERIES (K936236)Shimadzu Medical Systems1995-05-11
STACLOT HEPARIN TEST KIT (K943517)American Bioproducts Co.1995-05-11
ROSSITER SINUS STENT (K951803)Smith & Nephew Richards, Inc.1995-05-11
BIOSTIM-HV (K946298)Progressive Concepts, Inc.1995-05-11
FUJI COMPUTED RADIOGRAPHY SYSTEMS (K944046)Fujifilm Medical System U.S.A., Inc.1995-05-11
B-D ULTRA-FINE II PEN NEEDLE (K950466)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-05-11
QCT-BONE MINERAL ANALYSIS SOFTWARE (K941127)Image Analysis, Inc.1995-05-11
FAST FIND GRID (K950980)Webb Research, Inc.1995-05-11
R-MED MINI-RETRACTOR (K950108)R-Med, Inc.1995-05-11
KARL STORZ ENDOVISION DIGIVIDEO (DIGITAL IMAGE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENDOSCOPIC PROCS (K950974)Karl Storz Imaging, Inc.1995-05-11
ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL (K940209)Ortho Diagnostic Systems, Inc.1995-05-11
CATHETERIZATION TABLE KS-60 (K951315)Shimadzu Medical Systems1995-05-11
DEPUY DURALOC 100C ACETABULAR CUP (K951674)Depuy, Inc.1995-05-11
NURTURE III (K924312)Bailey Medical Engineering1995-05-11
COAGUCHEK SYSTEM (K942884)Boehringer Mannheim Corp.1995-05-11
THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODE (K932149)Thought Technology , Ltd.1995-05-11
ED CORP RADIATION SCREEN (K944445)Med Corp.1995-05-11
PW DOPPLER VASCULAR PROBES (K935994)Koven Technology, Inc.1995-05-11
BIOSTOP G BONE CEMENT RESTRICTOR (K943727)Landos, Inc.1995-05-11
REAL TIME STEREOTIX (K941191)GE Medical Systems1995-05-11
PROPAQ 200 MONITOR (K945071)Protocol Systems, Inc.1995-05-10
ARGYLE AQUA-SEAL CONTINUOUS AUTOTRANSFUSION CHEST DRAINAGE UNIT (K942791)Sherwood Medical Co.1995-05-10
MARINR SERIES EP DIAGNOSTI CATHETERS (K951347)Medtronic Cardiorhythm1995-05-10
1481 T DIGITAL TELEMETRY SYSTEMS, ENHANCED (K945384)Siemens Medical Solutions USA, Inc.1995-05-10
CARRASYN HYDROGEL WOUND DRESSING, FDG PADS, CARRAGAUZE PADS, STRIPS (K951417)Carrington Laboratories, Inc.1995-05-10
NEONATAL BLOOD COLLECTION AND SCREENING FORM (K944618)General Business Forms, Inc.1995-05-10
FI02 SENSING MODULE (K944120)Core-M, L.P.1995-05-10
JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS (K951917)Johnson & Johnson Consumer Products, Inc.1995-05-10
EMI MODEL FFF-IA (K952164)New York Heart Instruments, Inc.1995-05-10
LARGE MUSCLE STRENGTH GAUGE (K945630)J-Tech, Inc.1995-05-10
ELCAT D-PPG, PLETHYSMOGRAPH DEVICE (K944395)Dermatology Assoc.1995-05-10
VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR (K941215)Sorin Biomedical, Inc.1995-05-10
CARDIAC EVENT RECORDER (INSTANT MEMORY 2000) (K942586)Telescan Medical Systems1995-05-10
LINVATEC STASYS-PES FIXATION DEVICE (K934321)Linvatec Corp.1995-05-10
SUNGLASSES, NONPRESCRIPTION (K951131)Gold, Inc.1995-05-10
BENSON AND ASHLEY (K951438)Benson & Ashley, Inc.1995-05-10
HOLTER SSR DIGICORDER(TM) (K942653)Del Mar Avionics1995-05-10
MABIS BRAND AND MABIS CUSTOMERS PRIVATE LABEL BRAND (K942072)Mabis Healthcare, Inc.1995-05-10
ACE SUPRACONDYLAR PLATE (K950618)Ace Medical Co.1995-05-10
ATI DISPOSABLE TEST PACK FOR EO GAS STERILIZATION (K951063)Pymah Corp.1995-05-10
INCLUSIVE ENDOSCOPE (K943356)Danek Medical, Inc.1995-05-10
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