Atlas FDA

2002

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

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RecordFirmDate
UNIFIL FLOW (K020342)GC America, Inc.2002-03-28
ORTHOSS RESORBABLE BONE VOID FILLER (K014289)Geistlich-Pharma2002-03-28
ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS (K020621)Arthrocare Corp.2002-03-28
CODMAN HAKIM SHUNT SYSTEMS (K020667)Codman & Shurtleff, Inc.2002-03-28
THE HAMMER MODEL H100 (K012041)Tenacore Holdings, Inc.2002-03-28
CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP (K013714)Codan US Corp.2002-03-28
MODIFICATION TO SPARC SLING SYSTEM (K020663)American Medical Systems, Inc.2002-03-28
ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000); ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; AND WANDS (K020622)Arthrocare Corp.2002-03-28
ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM (K013551)Computer Motion, Inc.2002-03-28
PBS, PBSW WITH CATIONS AND PHENOL RED (K020490)Conception Technologies2002-03-28
IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR (K013984)Diagnostic Products Corp.2002-03-28
WIZAIR DVT (K012994)Medical Compression Systems (Dbn) , Ltd.2002-03-27
NORAPAD PLAIN; NORAPAD TA (K014268)Perlei Medical, Inc.2002-03-27
UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR (K013949)Churchill Medical Systems, Inc.2002-03-27
GLASS POST (K012849)J. Morita USA, Inc.2002-03-27
GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E (K012520)Cardiac Assist Devices, Inc.2002-03-27
UNIVERSAL BONE PLATE III SYSTEM (UBP III) (K020611)Spinal Concepts, Inc.2002-03-27
PROCERA ALLCERAM BRIDGE MATERIAL (K020269)Procera Sandvik AB2002-03-27
OMNI OXYGEN SYSTEM, MODEL 1000 (K013931)Sequal Technologies, Inc.2002-03-27
MRSA-SCREEN (K011400)Denka Seiken'S2002-03-27
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM (K020322)Becton, Dickinson & CO2002-03-27
BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S (K014304)Triage Medical, Inc.2002-03-27
EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302 (K020031)Neothermia Corp.2002-03-27
PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS (K020680)Cordis Neurovascular, Inc.2002-03-27
TISSUELINK SOLID CYLINDER MONOPOLAR DEVICE (K014260)Tissuelink Medical, Inc.2002-03-27
ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY (K020806)Bayer Corp.2002-03-27
PERIOLASE ND:YAG DENTAL LASER SYSTEM (K014272)Millennium Dental Technologies, Inc.2002-03-27
MODIFICATION TO PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT (K020881)Science Incorporated2002-03-27
SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8 (K013488)Sophysa SA2002-03-27
M3 (MIRCO-MULTILEAF COLLIMATOR (K004022)Brainlab AG2002-03-26
BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL BMCD-35-3040, MBCD-35-4050 (K014243)Triage Medical, Inc.2002-03-26
EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS (K012852)Optonol, Ltd.2002-03-26
ACCESS SEQUESTRATION SYSTEM (K012406)Interpore Cross Intl.2002-03-26
SENSITITRE HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE (K014259)Trek Diagnostic Systems, Inc.2002-03-26
PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB (K010131)Aksys, Ltd.2002-03-26
MOONRAY MOBILE C-ARM (K013426)Simad S.R.L.2002-03-26
SMITH & NEPHEW TWINFIX TI QUICK T (K020159)Smith & Nephew, Inc.2002-03-26
CLINICON WAVEGUIDE PLATFORM WITH INTERCONNECT FOR LUXAR ACCESSORIES (K014236)Clinicon Corp.2002-03-26
I-FLOW ELASTOMERIC PUMP (K020862)I-Flow Corp.2002-03-26
DERMACHILLER 4 (K014253)Paradigm Trex, LLC2002-03-26
CARD IQ ANALYSIS II (K020796)GE Medical Systems2002-03-26
1,25-DIHYDROXYVITAMIN D125I RIA (K014030)DiaSorin, Inc.2002-03-26
NTERO HOTROD SYSTEM (K014251)Ntero Surgical, Inc.2002-03-26
JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE (K014303)Jostra AG2002-03-26
FLOWTRON UNIVERSAL, MODEL AC600 (K010744)Huntleigh Healthcare, Inc.2002-03-26
COSMED QUARK C12/QUARK T12 (K014262)Cosmed Srl2002-03-26
DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, M-NSAT AND ACCESSORIES (K020479)Datex-Ohmeda2002-03-26
JOE LUB HELMET CONDOM (K011378)Marketing Sales Concepts, Inc. (Msci)2002-03-25
UNICEM (K020256)3M Espe AG Dental Products2002-03-25
VITEK 2 ANTIMICROBIAL SUSCEPTIBILITY TEST SYTEM FOR SPARFLOXACIN (K020870)bioMerieux, Inc.2002-03-25
3M ATTEST 290 AUTO-READER (K004009)3M Company2002-03-25
ZOLL PAD (K011388)Zoll Medical Corp2002-03-25
JOE LUBE CONDOM (K011363)Marketing Sales Concepts, Inc. (Msci)2002-03-25
CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDS (K020596)Diamond Diagnostics, Inc.2002-03-23
DRIED GRAM NEGATIVE MIC/COMBO PANELS (K020037)Dade Microscan, Inc.2002-03-22
X-SERIES BI-METRIC HIP FEMORAL COMPONENTS (K020580)Biomet, Inc.2002-03-22
PRONTO (K014240)Hitachi Medical Systems America, Inc.2002-03-22
DIABETES ASSISTANT SOFTWARE (K014139)Roche Diagnostics Corp.2002-03-21
PF-3, BATTERY OPERATED, FOUR WHEEL, POWER SCOOTER, MODEL PF-3 (K020001)Transworld Mobility Distribution, LLC2002-03-21
CAT ACTIVE WHEELCHAIR (K020737)Movingpeople.Net2002-03-21
DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER (K014248)Urogyn , Ltd.2002-03-21
KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622; KODAK DIRECTVIEW CR 900 SYSTEM, CATALOG# 1170976 (K020635)Eastman Kodak Company2002-03-21
PVS 1500 SDS (K020733)Precision Vascular Systems, Inc.2002-03-21
REPOSABLE INSTRUMENT SYSTEM, MODELS MF001-MF083 (K014207)Aesculap, Inc.2002-03-21
ODI TALON INTRAMEDULLARY HIP NAIL (K014189)Orthopedic Designs, Inc.2002-03-21
SYNTHES HIGH TIBIAL OSTEOTOMY PLATE (K014197)Synthes (Usa)2002-03-21
VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET; MODEL 108 (K020450)Maine Standards Co.2002-03-21
MODIFICATION TO SURGICAL TITANIUM MESH SYSTEM (K020522)Depuyacromed2002-03-21
SECCA SYSTEM (K014216)Curon Medical, Inc.2002-03-21
OPTILUX 501 (K020091)Kerr Corporation (Danbury)2002-03-21
RELIEFBAND DEVICE, MODELS RB-DL, RB-EL, RB-RL (K020180)Woodside Biomedical, Inc.2002-03-21
URS-IG (GLUCOSE TEST) (K020175)Teco Diagnostics2002-03-21
LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE (K020558)Integra Neurosciences2002-03-21
ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS (K020557)Arthrocare Corp.2002-03-21
DINAMAP PRO 1000 MONITOR, MODEL 1000 (K012915)Ge Medical Systems Information Technologies2002-03-21
SAFYRE SLING SYSTEM (K020007)Promedon2002-03-21
MODEL P-33, BATTERY OPERATED, THREE WHEEL, POWER SCOOTER , MODEL P-33 (K020002)Transworld Mobility Distribution, LLC2002-03-21
MODEL 733HC GRAVITY/VACUUM STEAM STERILIZER (K020590)Getinge/Castle, Inc.2002-03-20
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEX (K020777)Respironics, Inc.2002-03-20
VISUALINE BARBITURATES DIPSTRIP TEST (K020136)Sun Biomedical Laboratories, Inc.2002-03-20
TOUCH&BOND-PLUS (K020239)Parkell, Inc.2002-03-20
METHADONE (K013001)Abbott Laboratories2002-03-20
HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO (K020660)I-Flow Corp.2002-03-20
DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070 (K012989)Dolphin Medical, Inc.2002-03-20
RESORB-X RESORBABLE PLATING SYSTEM (K011590)KLS-Martin L.P.2002-03-20
CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR; MODELS 466-P306AU & 466-P306BU (K020316)Cordis Corp.2002-03-20
LATEX EXAMINATION GLOVES (POWDER FREE) (K014279)Brightway Gloves Pvt. , Ltd.2002-03-20
DAVLITE MICROENDOSCOPE & ACCESSORIES (K020310)Davlite Technologies2002-03-20
RAPIDONE-OXY TEST (K014101)American Bio Medica Corp.2002-03-20
BARBITURATES (K012996)Abbott Laboratories2002-03-20
BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757 (K020523)Bd2002-03-20
PELVICFLEXER EXERCISE DEVICE (K011688)Pelvicflex, Inc.2002-03-20
PATIENTNET MONITORING SYSTEM (K020524)General Electric Medical Systems Information Techn2002-03-20
SULZER DENTAL CERAMIC SYSTEM-HEXLOCK (K014175)Sulzer Dental, Inc.2002-03-20
PASCO MIC AND MIC/ID PANELS (K020331)Pasco Laboratories, Inc.2002-03-20
LATEX EXAMINATION GLOVE (POWDERED) (K014280)Brightway Gloves Pvt. , Ltd.2002-03-20
PHILIPS MULTI-PARAMETER MODULE, MODEL M3001A; PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.02, MODEL M1275B (K020531)Philips Medical Systems2002-03-20
PROPOXYPHENE (K013100)Abbott Laboratories2002-03-20
INCARE PELVIC FLOOR THERAPY SYSTEM (K013612)Hollister, Inc.2002-03-19
IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3 (K020237)Consolidated Technology2002-03-19
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Every clearance here is in the API, with alerts when new ones post.