Atlas FDA

1998

3,775 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SUNGLASSES (K974441)Hip Shing Fat Co., Ltd.1998-01-09
MANAN GENERAL PURPOSE INTRODUCER NEEDLE (K980004)Medical Device Technologies, Inc.1998-01-09
ARTHROCARE SINUS ELECTROSURGERY SYSTEM (K973478)Arthrocare Corp.1998-01-09
MANAN(TM) SUPER-CORE BIOPSY NEEDLES (K974814)Medical Device Technologies, Inc.1998-01-09
MASIMO SET MS-1P PULSE OXIMETER AND THE LNOP SERIES OF SENSORS AND CABLES (K973887)Masimo Corp.1998-01-08
RUSCH BRILLANT SILICONE FOLEY CATHETER (K972184)Rusch Intl.1998-01-08
BACTEC MYCO/F LYTIC CULTURE VIALS (K970512)Becton Dickinson Microbiology Systems1998-01-08
ATRION MEDICAL COATED LACRIMAL INTUBATION SET (K973872)Atrion Medical Products, Inc.1998-01-08
TRIAGE(R) CARDIAC PANEL CALIBRATION VERIFICATION CONTROLS, TRIAG (R) MYOGLOBIN CALIBRATION VERIFICATION CONTROLS, TRIAGE (K974827)Biosite Incorporated1998-01-08
GLYDE DAM LOLLYES (K970577)Glyde USA, Inc.1998-01-08
HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18, MED-18,MED-1,MED-T-1,MEDD-18,MED-38,MED-T-10,MED-T-25,MED-T-5 (K971442)Humed, Inc.1998-01-08
MANAN ACCURA NEEDLE (K974741)Medical Device Technologies, Inc.1998-01-08
MANAN AUTOMATIC CUTTING NEEDLE (K974446)Manan Medical Products, Inc.1998-01-08
VISTACAM OMNI AND VIASTCAM OMNI (IC) (K974204)Air Techniques, Inc.1998-01-08
PHILLIPS EASY VISION FAMILY WORKSTATION OPTION ENDO 3D (K973983)Philips Medical Systems, Inc.1998-01-08
MANAN TECHNA-CUT ASPIRATION NEEDLE (K974766)Medical Device Technologies, Inc.1998-01-08
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) (K973868)Osteotech, Inc.1998-01-08
CHEMO-SPIKE II RECONSTITUTION DEVICE (K974431)Medi-Dose, Inc.1998-01-08
ZIPPY (K972851)Pillar Technology, Inc.1998-01-08
AUTOMATED DISPOSABLE KERATOME (ADK) (K974004)Lasersight Technologies, Inc.1998-01-08
STELA MODEL UJ45 PACING LEADS (K972574)Ela Medical, Inc.1998-01-08
AMBULATORY X-12 TELEMETRY MODULE (K974149)Mortara Instrument, Inc.1998-01-08
KSEA PLASTIC TROCARS (K974366)Karl Storz Endoscopy1998-01-08
ELECTRODES/PROBES/DEVICES (K974637)Ximed/Prosure/Injectx1998-01-07
OVULON MONITOR (K973860)Conception Technology, Inc.1998-01-07
TRACE REAGENT LINE FOR THE COBAS MIRA (K973869)Trace America, Inc.1998-01-07
CHASE ANASTOMOSIS VISUALIZATION DEVICE (K974568)Chase Medical, Inc.1998-01-06
APOLLO 9500 (K974369)Ion Laser Technology1998-01-06
POWDER FREE HYPROALLERGENIC EXAMINATION GLOVE (WITH LOW PROTEIN CLAIM) (K974065)Tillotson Healthcare Corp.1998-01-06
RANDOX IRON (K974604)Randox Laboratories, Ltd.1998-01-06
PHILIPS EASYVISION WORKSTATION (K973835)Philips Medical Systems, Inc.1998-01-06
V3 VALVE (K974145)B.Braun Medical, Inc.1998-01-06
ELECSYS PSA (ON ELECSYS 1010) (K974189)Boehringer Mannheim Corp.1998-01-06
BIOABSORBABLE BANKART TACK (K973849)Hogan & Hartson1998-01-06
PHYSIO/1000 (K974070)Physio Designs, Inc.1998-01-06
PRE-POWDERED PATIENT EXAMINATION GLOVE (K973831)Safe Glove , Ltd.1998-01-06
SANKO INTRAORAL DENTAL X-RAY (K972921)Sanko X-Ray Manufacturing Co., Ltd.1998-01-06
CLS STEM, WAGNER REVISION STEM, ALLOCLASSIC ZWEYMULLER STEM, SL (K973837)Sulzer Orthopedics, Inc.1998-01-06
SHENG HO (K964819)Shang HO Industrial Corp. , Ltd.1998-01-06
REP CHOLESTEROL PROFILE CONTROL-II (K974609)Helena Laboratories1998-01-06
MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED (K974296)Invacare Corp.1998-01-06
PATIENT EXAMINATION POWDER-FREE GLOVES (K973020)Wear Safe Malaysia Sdn. Bhd.1998-01-06
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M12/630 (K973851)Alexander Mfg. Co.1998-01-05
DRG LARGE SCREW SYSTEM (K973810)Dolphin Medical Technologies, Inc.1998-01-05
INCUWARMER (K971366)Hill-Rom, Inc.1998-01-05
CORDIS HYDRONOL STEERABLE GUIDEWIRE (K973845)Cordis Corp.1998-01-05
O BUTMENT HS IMPLANT (K973926)O Co., Inc.1998-01-05
POWDER FREE NITRILE EXAMINATION GLOVES - POLYMER COATED (K974443)P.T. Latexindo Tobaperkasa1998-01-05
NPG + 2 (K972971)Aalba Dent, Inc.1998-01-05
FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633 (K974647)Customed, Inc.1998-01-05
PRE-POWDERED NITRILE EXAMINATION GLOVES (K974442)P.T. Latexindo Tobaperkasa1998-01-05
PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S) (K970648)Renal Systems, Inc.1998-01-05
PRIMA KTP LASER SYSTEM (K973828)Nidek, Inc.1998-01-05
ADHESIVE HYBRID IONOMER CEMENT (K974140)Dentsply Intl.1998-01-05
IMAGEACCESS SYSTEM (K973805)Storcomm, Inc.1998-01-02
S-57 VIDEO IMAGING SYSTEM (K973794)Sopro1998-01-02
BARCO MWD 321 MEDICAL WORKSTATION DISPLAY (K972701)Barco NV Display Systems1998-01-02
CARDIAC TAGGING TECHNIQUES/MAGNETOM VISION AND MAGNETOM IMPACT (K973799)Siemens Medical Solutions USA, Inc.1998-01-02
S-41 &41S VIDEO IMAGING SYSTEM (K973796)Sopro1998-01-02
AIMSTICK PBD PREGNANCY (K974368)Germaine Laboratories, Inc.1998-01-02
TANGO NON-INVASIVE BLOOD PRESSURE MONITOR (K970629)Suntech Medical Instruments, Inc.1998-01-02
UNIVERSALPLUS LAPAROSCOPIC ABC/ELECTROSURGICAL ELECTRODE (K973890)Conmedcorp1998-01-02
AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) (K974620)Trace America, Inc.1998-01-02
CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800 (K973457)Shared Systems, Inc.1998-01-02
IMMULITE FREE T3 (K974634)Diagnostic Products Corp.1998-01-02
GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM (K971653)Clinical Diagnostics, Inc.1998-01-02
NORTHWEST RADIATION THERAPY PRODUCTS, PRECISION STEPPER AND GUIDE (K973786)Nw Radiation Therapy Products1998-01-02
SAFE NEEDLE DIRECT BLOOD TRANSFER DEVICE, MODEL TA-STV (K974374)Ohmeda Medical1998-01-02
QUANTA LITE REBELLA IGG (K971304)Inova Diagnostics, Inc.1998-01-02
S-52 ELECTRONIC VIDEO LAPAROSCOPE (K973795)Sopro1998-01-02
FOUNDATION FRACTURE STEM (K973809)Encore Orthopedics, Inc.1998-01-02
AIMSTICK PBD COMBO PREGNANCY (K974512)Germaine Laboratories, Inc.1998-01-02
SPIFE IFE-6 (K973040)Helena Laboratories1998-01-02
MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR (K973863)Hi-Tronics Designs, Inc.1998-01-02
STC COCAINE METABOLITE MICRO-PLATE EIA (K973651)OraSure Technologies, Inc.1998-01-02
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