Atlas FDA

1995

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

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RecordFirmDate
ORGENTEC ANTI-TPO ELISA (K952129)American Laboratory Products Co., Ltd.1995-06-20
ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AND PU 12300 (K951259)Impulso Trading Co.1995-06-20
AURAFLEX B2-MICROGLOBULIN (K944846)Organon Teknika Corp.1995-06-20
ABOND (K952124)Parkell, Inc.1995-06-20
N LATEX IGA (K952309)Behring Diagnostics, Inc.1995-06-20
SIGNA ADVANTAGE MAGNETIC RESONANCE SYSTEM-HISPEED PERFORMANCE OPTIONS (K941666)General Electric Co.1995-06-19
PULSE KLYSTRON AMPLIFIFER (L-5822-90) (K951143)Litton Systems, Inc.1995-06-19
LAPAROSCOPIC SURGERY INSTRUMENTS (K932033)Medline1995-06-19
CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY (K951059)Ciba Corning Diagnostics Corp.1995-06-19
COATED TUNGSTEN EYESHIELD (K945515)Medtec, Inc.1995-06-19
KARL STORZ INFANT, BALLOON VAGINOSCOPE, VAGINOSCOPE SHEATH, FIBER OPTIC LIGHT CARRIERS, ADJUSTABLE MAGNIFIERS (K950639)KARL STORZ Endoscopy-America, Inc.1995-06-19
ZOMED MODEL 10 CAUTERY BIOPSY DEVICE (K951659)Zomed Intl.1995-06-19
HEMO-BARRIER TOURNIQUET (K950258)Hemo-Barrier Technologies, Inc.1995-06-19
ELI URINE CONTROLS (K951817)Elsohly Labs, Inc.1995-06-19
ADVANCED NMR SYST INSTASCAN/MODIF: T1 & TE STEPPING (K944070)Advanced Nmr Systems, Inc.1995-06-19
T-300 COOLER (K945468)Temptek, Inc.1995-06-19
VARIOUS UHMWP HIP & KNEE JOINT PROSTHESIS MODIFIED (K951356)Biologically Oriented Prostheses1995-06-19
WIDEX MODEL LOGO 32 (L32) (K952229)Widex Hearing Aid Co., Inc.1995-06-19
WITT BIOMEDICAL IMAGE III (K945582)Witt Biomedical Corporation1995-06-19
PARAMAX ALANINE AMINOTRANSFERASE (GPT) REAGENT (K951332)Dade Intl., Inc.1995-06-19
LEGEND (K952441)Health Care Mfg., Inc.1995-06-19
CORFLO 300 PUMP (K944750)Corpak, Inc.1995-06-19
VMI 1000 SURGICAL PACEOMETER (K951145)Vision Medical Instruments, Inc.1995-06-19
MULTI-DOP S (K926363)Dantec Medical, Inc.1995-06-19
DINAMAP PLUS VITAL SIGNS MONOITOR (K943709)Critikon Company, LLC1995-06-16
WOODBINE/SOLOS VCM-3, HIGH RESOLUTION ONE-CHIP SURGICAL CAMERA (K951522)Woodbine Optical Corp.1995-06-16
C-FLEX ENDOLYMPHATIC SHUNT (K952227)Trebay Medical Corp.1995-06-16
SYSTEM 12 P1 26MM ACETABULAR INSERT (K951114)Howmedica Corp.1995-06-16
AIR CLEANERS WITH HEPA FILTRATION (K930521)The Rival Co.1995-06-16
AROMATIC CONDOM, ESSENTIALS, MI VIDA & JIFFI (K932985)Sime Health, Ltd.1995-06-16
SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHER (K951304)Synthes (Usa)1995-06-16
PULSE*SPRAY INFUSION SYSTEM (K951509)Angiodynamics, Div. E-Z-Em, Inc.1995-06-16
MODEL #5000 PULMO PLUS (K946039)International Medical Systems1995-06-16
CARDICO SHARPS CONTAINERS (1.5, 5, 9, 13, 21QTS.) (K946041)Cardico, Inc.1995-06-16
SPYROFOAM WOUND DRESSING (K951730)Polymedica Industries, Inc.1995-06-16
VS1 PLUS (K952499)Metalor Dental USA Corp.1995-06-16
NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS (K950499)American Hydro-Surgical Instruments, Inc.1995-06-16
RICHARDS PORP (K952481)Smith & Nephew Richards, Inc.1995-06-16
S-SCORT (K952632)Sscor1995-06-16
CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628 (K952233)Victoreen, Inc.1995-06-16
ISOLYSER SHARPS MANAGEMENT SYSTEM SMS (K943626)Thantex Specialties, Inc.1995-06-16
HOWMEDICA VITALOCK 22MM ACERTABULAR SHELL AND SYSTEM 12 INSERTS (K951115)Howmedica Corp.1995-06-16
AURIUM 68M (K952402)Argen Precious Metals, Inc.1995-06-16
PULSE KLYSTRON AMPLIFIER (L-5822-00) (K951142)Litton Systems, Inc.1995-06-16
IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM (K952456)Fisher Imaging Corp.1995-06-16
MMS-2400 (K941843)Parvo Medics, Inc.1995-06-16
OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT (K950521)Osteonics Corp.1995-06-16
ACUTOME(R) 150 MULTI-WAVELENGTH COLOR-CORRECTED(TM) LASER HANDPIECE (K950215)Reliant Laser Corp.1995-06-15
STAINLESS STEEL GREEN VENA CAVA FILT W/12F INTR SY (K912035)Boston Scientific Corp1995-06-15
CITATION POWER TOOL (K946290)Citation Medical Corp.1995-06-15
MEDRAD ENVISION CT INJECTOR AND QWIK FIT SYRINGE (K934086)Medrad, Inc.1995-06-15
DESRA (K945820)D.S.R.A., Inc.1995-06-15
CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE (K951479)Trinity Laboratories, Inc.1995-06-15
NEITZ SLIT LAMP SL-H2 (K951341)Neitz Instruments Company, Ltd.1995-06-15
STANDARD FOLEY SYSTEM PAK (K951443)Trinity Laboratories, Inc.1995-06-15
MULTI-LEVEL CONTROL FOR FIBRIN DEGRADATION PRODUCTS (K943571)More Diagnostics1995-06-15
ALADAN HYPOALLERGENIC LATEX MEDICAL EXAMINATION GLOVES (K951839)Aladan Corp.1995-06-15
ACTIC 2002 (K946169)North Atlantic Rehabilitation, Inc.1995-06-15
CARDON PHYSICAL THERAPY TABLES MODELS R28591 & R28592 (K951906)Cardon Rehabilitation Products, Inc.1995-06-15
KARL STORZ TAKE-APART ROTATING GRASPING FORCEPS (K952149)KARL STORZ Endoscopy-America, Inc.1995-06-15
DISPOSABLE LATEX PATIENT EXAMINATION GLOVES (K951670)Emi Groups (U.S.A.), Inc.1995-06-15
ACCESS EXPANSION SYSTEM (K951894)Micro-Medical Devices, Inc.1995-06-15
B-D DIGITAL THERMOMETER (K945427)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-06-15
T-UPTAKE CALIBRATORS (K951585)Diagnostic Reagents, Inc.1995-06-15
ALPHA POROUS COATED FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL) (K950418)Wrightmedicaltechnologyinc1995-06-15
AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM (K951462)Allergan Medical Optics1995-06-15
RUSCH URODYNAMIC RECTAL BALLOON CATHETER (K952573)Rusch Intl.1995-06-15
VICRYO* (POLYGLACTIN 910) BRAIDED COATED AND UNCOATED SYNTHETIC ABSORBABLE SUTURE, DYED & UNDYED, BRAIDED AND MONOFILAMT (K946271)ETHICON, Inc.1995-06-15
ITI ANGLED ABUTMENT (K941393)The Straumann Co.1995-06-14
IMPLA-MED LOW MARGIN ABUTMENTS, SCREWDRIVER, POLISHING PROTECTOR (K946198)Sterngold1995-06-14
IMPROVED PASSIVATION METHOD FOR METALLIC ORTHOPAEDIC IMPLANTS (K934590)Smith & Nephew Richards, Inc.1995-06-14
MULTI-DOP X (K931801)Dantec Medical, Inc.1995-06-14
SMARTFLOW I ADMINISTRATION SET (K945298)River Medical, Inc.1995-06-14
POC ARTHROSCOPE AND ACCESSORIES (K945684)Precision Optics Corp.1995-06-14
OLYMPUS ARTHROSCOPY SYSTEM (K951354)Olympus America, Inc.1995-06-14
WOUND CARE MANAGEMENT KITS (K952335)Continental Medical Laboratories, Inc.1995-06-14
MICROSURGE BIPOLAR GRASPERS (K951230)Microsurge, Inc.1995-06-14
MYOEXORCISER II FUAL (K951969)Verimed Holdings, Inc.1995-06-14
INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS) (K950077)Par Vision Systems Corp.1995-06-14
ELASTOMERIC SLEEP APPLIANCE (K946112)Village Park Orthodontics1995-06-14
KARL STORZ PUNCTURE, INJECTION, ENDOSCOPIC, VERESS NEEDLE (K951190)KARL STORZ Endoscopy-America, Inc.1995-06-14
PRECISION LINK BLOOD GLUCOSE DATA MANAGEMENT SYSTEM (K952279)Medisense, Inc.1995-06-14
DISPOSABLE & REUSABLE BIPOLAR SUCTION COAGULATOR (K950375)Boston Surgical Products, Inc.1995-06-14
QUEST RETROGRADE CARDIPLEGIA CANNULA-RCCS (K951088)Quest Medical, Inc.1995-06-14
PALLIAG NF IV (K951789)Degussa Corp.1995-06-14
WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT (K951519)Wells Johnson Co.1995-06-14
PRESSURIZER (K951988)Promedic, Inc.1995-06-14
HCI TUBE STABILIZER (K942529)Health Care Contracts, Inc.1995-06-14
PULSE*SPRAY INFUSION SYSTEM (K951602)Angiodynamics, Div. E-Z-Em, Inc.1995-06-14
STORZ MICROSEAL DP8030 & DP8045 PHACOEMULSIFICATION NEEDLES (K952259)Storz Instrument Co.1995-06-14
TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 (K950234)Emd Chemicals, Inc.1995-06-14
ELECTROSURGICAL DISPERSIVE ELECTRODE (K952577)Medtrex, Inc.1995-06-14
ROGOZINSKI SPINAL ROD SYSTEM SCREW (K930298)Smith & Nephew Richards, Inc.1995-06-14
MODEL 3200P/3200PR HYPERBARIC CHAMBER (K950386)Sechrist Industries, Inc.1995-06-13
0.035 IN. WISE WIRE (K942927)Boston Scientific Corp1995-06-13
MODEL 2500E/2500ER HYPERBARIC CHAMBER (K934164)Sechrist Industries, Inc.1995-06-13
ENTEROCOCCUS SCREENING MEDIUM (K951539)Becton Dickinson Microbiology Systems1995-06-13
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY (K944979)GE Medical Systems1995-06-13
VIDAS LYME SCREEN II (K943812)Biomerieux Vitek, Inc.1995-06-13
KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ENDOSCOPIC ARTHROSCOPY PROCEDURES (K945787)KARL STORZ Endoscopy-America, Inc.1995-06-13
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Every clearance here is in the API, with alerts when new ones post.