Atlas FDA

1999

3,554 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MINI-PORT (K992904)Taut, Inc.1999-10-05
V.T.S., INC. (V.T.-3) (K992442)Vts, Inc.1999-10-05
ASCENT KNEE SYSTEM (K993111)Biomet Manufacturing, Inc.1999-10-05
MBA (K993057)Merit Medical Systems, Inc.1999-10-05
DYONICS VARICOSE VEIN ABLATION BLADE (K990723)Smith & Nephew, Inc.1999-10-05
CAUTERY CLAMP AND BATTERY PACK POWER SUPPLY (K992460)Starion Instruments1999-10-05
PREFERENCE TREATMENT SYSTEM (K983793)Northwest Medical Physics Equipment, Inc.1999-10-05
INTRADUCER (K992907)Taut, Inc.1999-10-05
NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM (K990324)Nuvasive, Inc.1999-10-05
MICROGRASP MONOPOLAR COAGULATOR, MODEL NOS 90001-90010 (K992714)Hysterx, Inc.1999-10-05
CARDIOQUANT TROPONIN I TEST (K992127)Spectral Diagnostics, Inc.1999-10-04
CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078 (K991531)Cordis Webster, Inc.1999-10-04
VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS (K993068)Ortho-Clinical Diagnostics1999-10-04
GENZYME DIRECT AMYLASE VERIFIER (K993132)Genzyme Corp.1999-10-04
INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM (K992262)Indigo Medical, Inc.1999-10-04
OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (K992466)Ocu-Ease Optical Products, Inc.1999-10-04
GLUMA COMFORT BOND + DESENSITIZER (K992292)Heraeus Kulzer, Inc.1999-10-01
PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES (K992271)Shanghai Cosmos Corp.1999-10-01
OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W (K992775)Hologic, Inc.1999-10-01
MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM (K992276)Sulzer Spine-Tech1999-10-01
BECTON DICKINSON SYRINGE (K992734)Bd Becton Dickinson Vacutainer Systems Preanalytic1999-10-01
PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES (K991965)Purilens, Inc.1999-10-01
ADVANTA GRAFT (>6MM) (K992960)Atrium Medical Corp.1999-10-01
ADVANTA GRAFT (<6MM) (K992958)Atrium Medical Corp.1999-10-01
T-ANASTAFLO (K990396)Edwards Lifesciences Research Medical1999-10-01
AUTOSPECT PLUS WITH INSTILL MOTION CORRECTION (K992317)Adac Laboratories1999-10-01
SILHOUETTE FC (K993090)Ge Medical Systems, Inc.1999-10-01
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K992272)Shanghai Cosmos Corp.1999-10-01
POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER (K990276)Porous Media Corp.1999-10-01
INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC (K990992)Roche Diagnostics Corp.1999-09-30
WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER (K991540)AngioDynamics, Inc.1999-09-29
INTRAMAX ITI GUIDE CATHETER (K992622)Intratherapeutics, Inc.1999-09-29
WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM (K992736)Wallach Surgical Devices, Inc.1999-09-29
S.S. WHITE TECHNOLOGIES, MODELS 6500-D,6500-E, AND 6500-F (K984415)S.S. White Technologies, Inc.1999-09-29
CARTO EP NAVIGATION SYSTEM (K992968)Biosense Webster, Inc.1999-09-29
DIAGNOSTIC ULTRASOUND, MODEL 1.0 (K992378)Volumetrics Medical Imaging, Inc.1999-09-29
DENZIR (K984201)Dentronic AB1999-09-29
OLYMPUS WORKING ELEMENT FOR PROBES (K992141)Olympus Winter & Ibe GmbH1999-09-29
SPRING POWERLITE 2000 (K992728)Spring Health Products, Inc.1999-09-29
KENDALL MODEL 7325 SCD RESPONSE COMPRESSION SYSTEM, MODEL 7325 (K992079)The Kendall Company, L.P.1999-09-29
3I CERAMIC ABUTMENT SYSTEM (K991947)Implant Innovations, Inc.1999-09-29
ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0 (K992352)Inteleradiology, Inc.1999-09-29
SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P (K992798)Sigma Diagnostics, Inc.1999-09-28
SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5 (K992801)Sigma Diagnostics, Inc.1999-09-28
KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C (K990500)The Kendal Co.1999-09-28
ORTHOPANTOMOGRAPH OP100D (K992385)Instrumentarium Corp.1999-09-28
SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P (K992800)Sigma Diagnostics, Inc.1999-09-28
ELECSYS PARATHYROID HORMONE TEST SYSTEM (K992680)Roche Diagnostics Corp.1999-09-28
ENDOSTEPPER 1 (K993188)Phytron- Elektronik GmbH1999-09-28
BROADLINE OR TOWELS (K991667)Broadline Medical Industries1999-09-27
MODIFICATION OF PASCO MIC AND MIC/ID PANELS (K992420)Pasco Laboratories, Inc.1999-09-27
PRE-POWDERED LATEX EXAMINATION GLOVE WITH OAT-STARCH POWDER (K992117)Pamitex Industries Sdn Bhd1999-09-27
HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE (K992810)Hwa Teh Industrial Sdn. Bhd.1999-09-27
NITRILE PATIENT EXAMINATION GLOVES, POWDERED, NON-STERILE (K992558)Riverstone Resources Sdn Bhd1999-09-27
LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM, VIEW SCOPE, SURGISCOPE,ELEKTA INSIGHT (K992882)Elekta Instrument AB1999-09-24
ELECSYS ESTRADIOL CALSET II (K992981)Roche Diagnostics Corp.1999-09-24
EXTRA-CARE LATEX PATIENT EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED (K992175)Ultrawin Sdn Bhd1999-09-24
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROCARE ELECTROSURGERY WAND, MODELS H2000 (K992972)Arthrocare Corp.1999-09-24
SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER (K992986)Salter Labs1999-09-24
DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE COLOR (K992686)Sheen More Ent. Co., Ltd.1999-09-24
DISPOSABLE HEATING TUBING SET #7642HSES (K990662)Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh1999-09-24
PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM (K992988)Home Diagnostics, Inc.1999-09-24
A-15 HEMODIALYZER (K992594)Althin Medical AB1999-09-24
BACT/ALERT FN (K992432)Organon Teknika Corp.1999-09-24
SILVERLON WOUND PACKING STRIPS (K984210)Argentum International, LLC1999-09-24
SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600 (K990253)Amba Medical , Ltd.1999-09-24
NTERO RF SLEEVE (K992572)Ntero Surgical, Inc.1999-09-24
PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-3) (K991090)Dynamic Systems, Inc.1999-09-24
VISINE FOR CONTACTS (K991620)Pfizer, Inc.1999-09-24
AVCORE SYSTEM (K990816)Modular Cutting Systems, Inc.1999-09-24
RENEW RECEIVER (K992946)Advanced Neuromodulation Systems1999-09-24
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR (K992860)Shijiazhuang Hongray Plastic Products Co., Ltd.1999-09-24
QUICKVUE INFLUENZA A/B TEST (K991633)Quidel Corp.1999-09-24
PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM, MAGNESIUM, GLUCOSE, PYRUVATE AND PHENOL RED (K991378)Sage Biopharma1999-09-24
BIOCHECK FERRITIN ELISA MODEL BC-1025 (K992517)Biocheck, Inc.1999-09-24
QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES (K992671)Latexx Partners Bhd.1999-09-24
HEMOCHEK URINE COLLECTION KIT (K991800)Osborn Group, Inc.1999-09-24
MICROKERATOME, MODEL MK-2000 (K990900)Nidek, Inc.1999-09-24
CORE AUDIBLE TROCAR II (K992250)Core Dynamics, Inc.1999-09-24
MODIFICATION OF: CELL-DYN 1200 SYSTEM (K992444)Abbott Laboratories1999-09-24
EZ-HBT HELICOBACTER BLOOD TEST (K990931)Metabolic Solutions, Inc.1999-09-24
VAPR 2.3 MM SIDE EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM (K992876)Mitek Products1999-09-24
FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES, FLEXIBLE BRONCHOSCOPE (K992526)Richard Wolf Medical Instruments Corp.1999-09-24
PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA (K991381)Pacific Andrology, Inc.1999-09-24
MILLENIUM MICROKERATOME, MODEL IMD-001 (K992687)Industrial & Medical Design, Inc.1999-09-24
NMT NEUROSCIENCES CONTROL UNIT, MODEL 910-600 & NMT NEUROSCIENCES DISPOSABLE DRAINAGE LINE KIT, MODEL 910-6XX (K990660)Nmt Neurosciences Implants S.A.1999-09-23
AGILITY STEERABLE GUIDEWIRE (K991646)Cordis Neurovascular, Inc.1999-09-23
ARTHROSCOPE / MEDIFIX INC. (K992474)Medifix, Inc.1999-09-23
PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) (K990960)Perimed, Inc.1999-09-23
EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS (K992367)Electro-Biology, Inc.1999-09-23
ROTORBLADE SUTURE ANCHOR (K992938)Li Medical Technologies, Inc.1999-09-23
MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES (K992480)Medifix, Inc.1999-09-23
PHOTON RADIOSURGERY SYSTEM (PRS) (K992577)Photoelectron Corporation1999-09-23
MICRO-FRANCE LIPOSUCTION CANNULAS (K992282)Xomed, Inc.1999-09-23
SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN) (K992348)Synthes (Usa)1999-09-23
SURGISIS SLING (K992159)Cook Biotech, Inc.1999-09-23
SORING GMBH, SONOCA 300 (K992026)Soring GmbH Medizintechnik1999-09-23
E100M VENTILATOR (E100M) (K972833)Newport Medical Instruments, Inc.1999-09-23
MIRACLEBREATH TONGUE CLEANER (K992270)Stellar Labs, Inc.1999-09-23
MOSS MIAMI 6.35MM POLYAXIAL SCREW (K992168)Depuyacromed1999-09-23
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