Atlas FDA

2002

3,685 FDA 510(k) clearances · Clearance year

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RecordFirmDate
REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162 (K020646)Nobel Biocare Uas, Inc.2002-05-29
LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444 (K021384)Bio-Rad2002-05-29
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 469 (K021415)Bio-Rad2002-05-29
KSEA SCB MEDIA CONTROL (K020640)KARL STORZ Endoscopy-America, Inc.2002-05-28
SELECT STIM (K020637)Care Rehab and Orthopaedic2002-05-28
OSS LES PROXIMAL FEMORAL COMPONENT (K021380)Biomet, Inc.2002-05-28
GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420 (K020778)Gyrus Ent LLC2002-05-28
TSRH SPINAL SYSTEM (K020699)Medtronic Sofamor Danek, Inc.2002-05-28
NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER (K013687)Steven K. Sue2002-05-28
ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR (K011461)Access Cardiosystems, Inc.2002-05-28
DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570 (K021118)Class A Ent.2002-05-28
NORAD NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE (K020893)Dennis R. Bailey, Dds2002-05-28
PADPRO, MODEL 2502 (K020743)Padpro, LLC2002-05-28
EZ-SCOPE AN & EZ-SCOPE AN LITE (K020643)Health Policy Resorters Group, LLC2002-05-28
AROMACRYL (K021121)Aromacryl, LLC2002-05-28
SOFT K. AND SOFT K. TORIC (XYLOFICON A) SOFT (HYDROPHILLIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR (K020642)Soflex Contact Lens Industries , Ltd.2002-05-24
CURELLE, PREFERRED CURELLE, CUTEQ 2.5 (K020628)Bioteque America, Inc.2002-05-24
SYNCRUS INTERNAL CARDIOVERSION SYSTEM (K020701)Guidant Corporation, Cardiac Surgery2002-05-24
G4 SLEEVED NAIL (K020962)Biomet Manufacturing, Inc.2002-05-24
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL (K021498)Bio-Rad2002-05-24
IRRIGATING CANNULA (K020614)Ca Guard, Ltd.2002-05-24
B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM (K021344)Vision-Sciences, Inc.2002-05-24
AT HOME OVULATION TEST, MODEL 9032 (K021409)Phamatech, Inc.2002-05-24
UNITY IS PATIENT VIEWER (K020661)General Electric Medical Systems Information Techn2002-05-24
SPECTRAL'S 2 IN 1 (TNI-MYO) (K020950)Spectral Diagnostics, Inc.2002-05-24
14F X 55CM ASH SPLIT-CATH XL, MODEL ASPC55-XL (K020315)Medcomp2002-05-24
STATUS HCG SERUM/URINE (K020439)Princeton BioMeditech Corp.2002-05-23
MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT DEVICES AND 105.988 FOR 230VOLT DEVICES (K021286)Nucletron Corp.2002-05-23
APATIGHT HA-BONE GRAFT SUBSTITUTE (K013960)Cerabio, LLC2002-05-23
FINESUN EMS STIMULATOR (K020684)Finesun Worldwide Intl. Co., Ltd.2002-05-23
QUICKCLOT (K013390)On Site Gas Systems, Inc.2002-05-23
PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046 (K020587)Pulsion Medical Systems AG2002-05-23
ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 (K020914)Helena Laboratories2002-05-23
EBI DFS OPTIROM ELBOW FIXATOR (K021312)Ebi, L.P.2002-05-23
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM) (K021324)Disco-O-Tech Medical Technologies, Ltd.2002-05-23
BLACKSTONE III DEGREE ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER) (K020620)Blackstone Medical, Inc.2002-05-23
LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET (K014192)Princeton BioMeditech Corp.2002-05-23
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM (K020321)Becton, Dickinson & CO2002-05-23
LIFESIGN DOA 4 (THC/OPI/COC/MET) (K014193)Princeton BioMeditech Corp.2002-05-23
MIDAS TOUCH LATEX EXAMINATION GLOVES-POLYMER COATED, POWDER FREE (K021465)Industrial Clothings, Ltd.2002-05-22
ORION NASAL CPAP SYSTEM (K020730)Bird Products Corp.2002-05-22
ULTRAGARD IMPERVIOUS REINFORCED GOWN (K013846)Precept Medical Products, Inc.2002-05-22
HDM97 (K020908)Ibp Instruments GmbH2002-05-22
ECLIPSE, HELIOS OPTION (K021268)Varian Medical Systems, Inc.2002-05-22
N2000 BASE STATION; N2001 NURSE STATION (K020584)Neptec Design Group, Ltd.2002-05-22
TELE-CLINIQ DATA TRANSMISSION SYSTEM BLOOD PRESSURE MEASUREMENT SYSTEM (K021447)Aerotel Medical Systems (1998) , Ltd.2002-05-22
IMAGINE H.E. PRESS DESIGN-CERAMIC (K020774)Wieland Dental + Technik GmbH & Co. KG2002-05-22
APPLIED URETERAL CATHETER (K020577)Applied Medical Resources Corp.2002-05-22
PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS (K021591)Cordis Neurovascular, Inc.2002-05-22
MODIFICATION TO SAFE-STEER GUIDE WIRE SYSTEM (K021323)Intra Luminal Therapeutics, Inc.2002-05-22
SMART GLOVE STERILE NITRILE EXAMINATION GLOVES (POWDERED FREE) (K021013)Smart Glove Corp. Sdn Bhd2002-05-22
MEDCOMP ASH SPLIT-CATH II (K020465)Medcomp2002-05-22
ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATION SYSTEM-1.0 AND 5.0 (K021082)On Site Gas Systems, Inc.2002-05-22
LATEX SURGEONS GLOVE (POWDER FREE) (K014283)Brightway Gloves Pvt. , Ltd.2002-05-22
OCO DENTAL IMPLANT (K021460)O Co., Inc.2002-05-22
ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR, MODEL CARDIOCARE 1000I (K021225)Rossmax International , Ltd.2002-05-22
BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER) (K020600)Blackstone Medical, Inc.2002-05-22
HISPEED DUAL (K021491)Ge Medical Systems, Inc.2002-05-22
DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N (K021435)Ge Medical Systems Information Technologies2002-05-22
HDM99 (K020909)Ibp Instruments GmbH2002-05-22
AVEA (K013642)Bird Products Corp.2002-05-22
DEXACARE G4 (K021331)Osteometer Meditech, Inc.2002-05-21
MAGNETOM SYMPHONY QUADRATURE TX/RX HEAD COIL (K021262)Usa Instruments, Inc.2002-05-21
ILLUMINATOR AUTOMATIC TUNE VOX AND INTERFACE CABLE (ATIB) (K020993)Magna-Lab, Inc.2002-05-21
MEDAMICUS AXIA RSN (K020563)Medamicus, Inc.2002-05-21
CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 (K021479)Heinz Kurz GmbH Medizintechnik2002-05-21
SIB CATHETER, MODEL 61-7005 (K021272)Ackrad Laboratories2002-05-21
INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL MICROCOIL, AND INTERCEPT VASCULAR INTERNAL MR COIL (K020790)Surgi-Vision, Inc.2002-05-21
TST - SUPPRESSOR MODEL #1000 (K013827)Neurosim Limited2002-05-21
SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW (K013897)Bio-Scan S.A2002-05-21
36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) (K021310)Howmedica Osteonics Corp.2002-05-21
SIMPLICITY EASY P SOFT INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN (K021530)Sterling Medivations, Inc.2002-05-21
ULTIMA TENS XL-A1 (K020846)Tenscare, Ltd.2002-05-21
KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT (K013982)Kinamed, Inc.2002-05-21
LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW (K021522)Walter Lorenz Surgical, Inc.2002-05-21
APEX 800 LASER SYSTEM, MODEL APEX 800 (K020849)Iridex Corp2002-05-20
GALILEO CAS/NAV TKR SYSTEM (K020298)Plus Orthopedics2002-05-20
SERRALESTER (K020902)Serral, S.A. DE C.V.2002-05-20
SYNTHES PILON PLATE (K020602)Synthes2002-05-20
AGILITY ANKLE REVISION PROSTHESIS (K020541)Depuy, Inc.2002-05-20
TISSUELINK BIPOLAR FLOATING BALL DEVICE (K020574)Tissuelink Medical, Inc.2002-05-20
BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE, MODEL BMHN1104VX, & BONE MARROW BIOPSY NEEDL (K020867)Worldwide Medical Technologies, LLC2002-05-20
TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP (K020780)Medex, Inc.2002-05-20
ISOSEEDS I-125 (K021343)Bebig Isotopen-Und Medizintechnik GmbH2002-05-20
MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ (K021025)Implex Corp.2002-05-20
CARBON POST (K012496)J. Morita USA, Inc.2002-05-17
AMSCO CENTURY MEDIUM STERILIZER 26 X 26 (K020747)STERIS Corporation2002-05-17
HOLY DRAGON BRAND ACUPUNCTURE NEEDLES (K021095)Wujiang City Hua Xin Medical Appliance Co., Ltd.2002-05-17
PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719 (K021274)Baxter Healthcare Corp2002-05-17
Z3 GUIDE CATHETER (K021256)Medtronic Vascular2002-05-17
QUICKVUE ONE-STEP HCG-COMBO (K020801)Quidel Corp.2002-05-17
SMARTWIRE/SMARTMAP PRESSURE SYSTEM (K021219)Jomed, Inc.2002-05-17
MICROSCAN MICROSTREP PLUS PANEL-TETRACYCLINE (K020939)Dade Microscan, Inc.2002-05-17
SIMPLICITY EASY ACCESS P INFUSION SET (K021487)Sterling Medivations, Inc.2002-05-17
INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400 (K011344)Collins Medical, Inc.2002-05-17
QUICKVUE ONE-STEP HCG-URINE (K020799)Quidel Corp.2002-05-17
VECTOR F SERIES HIGH-SPEED DENTAL HANDPIECES (K020113)Vector Research & Development2002-05-17
24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (K021212)Spire Biomedical, Inc.2002-05-17
PHILIPS TL 20W/01RS UV-B, PHILIPS PL-S 9W/01/2P UV, AND PHILIPS PL-L 36W/01/4P UV-B (K021092)Philips Lighting Co.2002-05-16
PULPDENT GLAZE II (K020514)Pulpdent Corporation2002-05-16
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Every clearance here is in the API, with alerts when new ones post.