Atlas FDA

2000

3,453 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15 (K000580)KLS-Martin L.P.2000-07-24
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO (K001933)Wako Chemicals USA, Inc.2000-07-24
WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX (K001934)Wako Chemicals USA, Inc.2000-07-24
MODEL CGS TILT SEATING SYSTEM FOR POWER WHEELCHAIRS (K001777)Invacare Corp.2000-07-24
ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY (K993706)Roche Diagnostics Corp.2000-07-24
ATRIUM LITE MESH (K002093)Atrium Medical Corp.2000-07-24
MACROSORBOS PROTECTIVE SHEET (K994158)Macropore Biosurgery, Inc.2000-07-24
WAKO AUTOKIT LP(A)/DADE DEMENSION (K001919)Wako Chemicals USA, Inc.2000-07-23
WAKO AUTOKIT LP(A)/ RA,500/1000, (K001920)Wako Chemicals USA, Inc.2000-07-23
WAKO AUTOKIT LP(A)/EXPRESS 550 (K001921)Wako Chemicals USA, Inc.2000-07-23
RESOLUTION CHOLESTEROL MONITOR (K000610)Lifestream Technologies, Inc.2000-07-21
KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD (K001424)Kawasumi Laboratories America, Inc.2000-07-21
MINICAM (K001541)Video Dental Concepts, Inc.2000-07-21
KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY (K001423)Kawasumi Laboratories America, Inc.2000-07-21
KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER (K001426)Kawasumi Laboratories America, Inc.2000-07-21
TAKE 1 BITE (K001876)Sybron Dental Specialties, Inc.2000-07-21
MEDIS 5MP1H QUAD-HEAD MEDICIAL DIAGNOSTIC DISPLAY SYSTEM (K001750)Barco NV Display Systems2000-07-21
CALCIJECT (K001050)Centrix, Inc.2000-07-21
CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510; WIRE, GUIDE, CATHETER, MODEL QSW1000 (K994141)Medtronic Ave, Inc.2000-07-21
ARIA (K001317)Del Mar Medical Systems, LLC2000-07-21
BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES (K001390)Biosense Webster, Inc.2000-07-21
PROTON BEAM THERAPY SYSTEM (PBTS) (K992414)Optivus Technology, Inc.2000-07-21
LIGHT-CURED ORTHODONTIC BAND CEMENT (K001446)Scientific Pharmaceuticals, Inc.2000-07-21
MODIFICATION TO AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100 (K002046)Vsm Technology, Inc.2000-07-21
THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM (K001530)Bioplate, Inc.2000-07-21
MODIFICATION TO OMEGA 21 SYSTEM (K001357)Ebi, L.P.2000-07-20
SYNTHES CERVIFIX SYSTEM (K001864)Synthes Spine2000-07-20
VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 (K001885)Ortho-Clinical Diagnostics, Inc.2000-07-20
MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500 (K001930)Nonin Medical, Inc.2000-07-20
ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP (K002126)Abbott Laboratories2000-07-20
MEDI-CULT UNIVERSAL IVF-MEDIUM (K991279)Medicult A/S2000-07-20
CPAP SYSTEM, MODEL 102001 (K001318)Sims Portex, Inc.2000-07-20
DR180-II (K001288)North East Monitoring, Inc.2000-07-20
STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX (K001306)Andromed, Inc.2000-07-20
TORNIER CEMENT RESTRICTOR (K001932)Tornier2000-07-20
BOOKER BOX, MODEL PAD 5010 (K993205)Tz Medical, Inc.2000-07-20
REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND (K001966)Micro Therapeutics, Inc.2000-07-20
PTA BALLOON CATHETER (K001087)Cook, Inc.2000-07-20
TI-MAX PROTRUSIO CAGE (K001376)Biomet, Inc.2000-07-20
MEDIS 2MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM (K001751)Barco NV Display Systems2000-07-19
COOL-TEC ELECTRODES (K001723)Seedling Enterprises., LLC2000-07-19
MODIFICATION TO CENTAUR SPINAL SYSTEM (K001844)Howmedica Osteonics Corp.2000-07-19
ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD (K001936)Arthrocare Corp.2000-07-19
O-LAS OPHTHALMIC PHOTODISRUPTOR (K001511)A.R.C. Laser AG2000-07-19
REDON SET (K001716)Pfm Produkte Fur Die Medizin AG2000-07-19
KSEA BIPOLAR COAGULATING ELECTRODES (K001630)Karl Storz Endoscopy2000-07-19
MICROVASIVE LITHOTRIPTOR FLEXPROBE II (K002084)Boston Scientific Corp2000-07-19
JILCO TRACTION-FLEXION CHAIR (K001361)Jilco Enterprises2000-07-19
THERMAGE THERMACOOL SYSTEM (K000944)Thermage, Inc.2000-07-19
LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM (FAMILY OF PRODUCTS) (K001746)Coherent Star2000-07-19
CONTROL SOLUTIONS INC, MODEL CS3101 (K993420)Control Solutions, Inc.2000-07-19
NANMA VACUUM PUMP (K993909)Nanma Mfg Co., Ltd.2000-07-19
LA PERSONAL SCOOTER (K000869)Assembled Products Corp.2000-07-19
GEM KNEE SYSTEM (K994214)Kinamed, Inc.2000-07-19
SPINAL PAD (K993684)Bioscan, Inc.2000-07-19
MEDIS 55MP1H SINGLE-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM (K001752)Barco NV Display Systems2000-07-19
MEDIS 5MP1H DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM (K001754)Barco NV Display Systems2000-07-19
J.A.G. LIGHTWEIGHT MANUAL WHEELCHAIR (K001298)Roll-Ability (Pty) , Ltd.2000-07-18
CA GUARD, LTD. PSP (PORT SITE PROTECTOR) (K992182)Ca Guard, Ltd.2000-07-18
PASCO MIC AND MIC/ID PANELS (K001612)Pasco Laboratories, Inc.2000-07-18
LIGHT PATCH (K993686)Bioscan, Inc.2000-07-18
BIOPACK (K993685)Bioscan, Inc.2000-07-18
OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION (K001964)Lobob Laboratories, Inc.2000-07-18
SURGILIGHT, INC EXCIMER LASER (K993328)Surgilight, Inc.2000-07-18
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (K001573)Trek Diagnostic Systems, Inc.2000-07-18
DASH 3000/4000 PATIENT MONITOR (K001359)General Electric Medical Systems Information Techn2000-07-18
AUTO SUTURE MICRO SURGICLIP CLIP APPLIER (K001450)United States Surgical, A Division of Tyco Healthc2000-07-18
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K001843)Cordis Corp.2000-07-18
MEDICAL IMAGE MERGE (MIM) (K001276)Syntermed, Inc.2000-07-17
ACCUSONIC PLUS, MODEL AP-100 (K001370)Metron Medical Australia, Pty, Ltd.2000-07-17
MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159 (K001698)Cogent Light Technologies, Inc.2000-07-17
ARTHROCARE FLOW CONTROL UNIT (K001904)Arthrocare Corp.2000-07-17
SPINAL CORD AND IMMOBILIZATION TRACTION SYSTEM (K001296)Cavendish Scott, Inc.2000-07-17
GC FUJICEM (K001730)GC America, Inc.2000-07-17
UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE (K993996)Univec, Inc.2000-07-17
INTRODUCER SHEATH (K001328)Novasys Medical, Inc.2000-07-17
LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE (K001582)Usa Instruments, Inc.2000-07-17
RIZA BAND STRETCHER (RBS)-60000 (K001236)R-Med, Inc.2000-07-17
GE MARQUETTE PRISM INFORMATION SERVER APPLICATIONS (K001268)General Electric Medical Systems Information Techn2000-07-17
KARL STORZ 3D VIDEO SYSTEM (K001362)Karl Storz Imaging, Inc.2000-07-17
ACCUSET SENSOR, MODEL 2000 (K001386)Pelvicare, Inc.2000-07-17
PHARMASEED, MODEL BT-125-3 (K994018)Syncor Pharmaceuticals, Inc.2000-07-17
PHARMASEED, MODEL BT-103-3 (K994016)Syncor Pharmaceuticals, Inc.2000-07-14
COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS0 (K001924)Allegiance Healthcare Corp.2000-07-14
SAMARCO SPIDER PLATES (K001271)Biomet, Inc.2000-07-14
HDI 5000 ULTRASOUND SYSTEM WITH EXTENDED FIELD OF VIEW IMAGING (K002003)Atl Ultrasound, Inc.2000-07-13
RETCAM II (K001275)Massie Research Laboratories, Inc.2000-07-13
POCKET ULTRASONIC PACHYMETER (K993674)Quantel Medical2000-07-13
ISOLETTE INFANT INCUBATOR, MODEL C2HS (K001242)Hill-Rom Air-Shields2000-07-13
FOCUS (K001729)Instrumentarium Corp.2000-07-13
MEDIS 2MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM (K001747)Barco NV Display Systems2000-07-13
ISLAND BIOSURGICAL BNS KIT #3 (K001583)Island Biosurgical, LLC2000-07-13
WELCH ALLYN INSTRUMENT INTERFACE MODULE (K001265)Welch Allyn, Inc.2000-07-13
BRAINSCAN (K994413)Brainlab AG2000-07-13
ELECSYS INSULIN CALSET (K001906)Roche Diagnostics Corp.2000-07-13
DATEX-OHMEDA NETWORK AND CENTRAL (K000647)Datex-Ohmeda, Inc.2000-07-13
FORMA SCIENTIFIC DIRECT HEAT INCUBATORS (K001524)Thermoquest Corp.2000-07-12
19 GA PLASTIC REINFORCED EPIDURAL CATHETER (K001587)Arrow Intl., Inc.2000-07-12
AMT THERAPEUTIC TABLE, MODEL 748AMT (K001401)Amt Mfg., Inc.2000-07-12
AMPLATZER SIZING BALLOON (K993248)Aga Medical Corp.2000-07-12
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Every clearance here is in the API, with alerts when new ones post.