Atlas FDA

1999

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

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RecordFirmDate
FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATOR (K991408)Thermoquest Corp.1999-07-19
GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043 (K991827)Ri Mos. S.R.L.1999-07-19
CUTE-LITE I LIGHT CURE UNIT (K991863)Rolence Enterprise Co. , Ltd.1999-07-19
MEDITRON STETHOSCOPE SYSTEM (K991367)Meditron AS1999-07-19
<GENX> FERTILIZATION MEDIA-HTF (K991173)<Genx> Intl., Inc.1999-07-19
SUMMER'S EVE LUBRICATING JELLY (K990597)C.B. Fleet Co., Inc.1999-07-19
STAT PROFILE M7 ANALYZER (K991727)Nova Biomedical Corp.1999-07-16
SOLO-CARE BRAND MULTI-PURPOSE SOLUTION (K991403)Ciba Vision Corporation1999-07-16
GEBAUER'S CHLORIDE FINE NOZZE (K991514)Gebauer Co.1999-07-16
RAPIDONE - OPIATES TEST (K990820)American Bio Medica Corp.1999-07-15
MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER (K991001)Ep Medsystems1999-07-15
PARKER FLEX-TIP TRACHEAL TUBE (K984528)Parker Medical Assoc.1999-07-15
TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE (K992122)Maxxim Medical1999-07-15
ANORECTAL MANOMETRY SUITE, MODEL 9032S0201 (K991389)Medtronic Functional Diagnostics A/S1999-07-15
N PROTEIN STANDARD UY (K991705)Dade Behring, Inc.1999-07-15
ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET) (K991490)Harry J. Bosworth Co.1999-07-15
SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101 (K991382)Genicon, LC1999-07-15
E9000 SYSTEM (K990524)Linvatec Corp.1999-07-15
DBSET MULTIDRUG SCREEN TEST KIT (K990681)Ameritek, Inc.1999-07-15
DYNAREX DRAIN SPONGE (K991694)Dynarex Corp.1999-07-15
ALGINATE IMPRESSION MATERIAL I (FAST & REGULAR SET) (K991489)Harry J. Bosworth Co.1999-07-15
DYNAREX NON-WOVEN SPONGE (K991695)Dynarex Corp.1999-07-15
RAPIDONE - COCAINE TEST (K990822)American Bio Medica Corp.1999-07-15
MODIFICATION TO ASTRA TECH IMPLANT - DENTAL SYSTEM (K990304)Astra Tech, Inc.1999-07-15
EZ-INTRO PERCUTANEOUS CATHETER SHEATH, EZ-INTRO VESSEL DILATOR (K983940)Adam Spence Corp.1999-07-15
NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L (K990941)Humagen Fertility Diagnostics, Inc.1999-07-14
BOVINE SERUM ALBUMIN (BSA) (K991338)Irvine Scientific Sales Co., Inc.1999-07-14
REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM (K991114)Lifecore Biomedical, Inc.1999-07-14
PRO-PORTION CLEANER/DISINFECTANT (K991509)Sultan Chemists, Inc.1999-07-14
NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS (K980380)Diametrics Medical, Ltd.1999-07-14
SOLAR 9500 INFORMATION MONITOR (K990068)General Electric Medical Systems Information Techn1999-07-14
DEPUY ROCKWOOD CLAVICLE PIN (K991649)Depuy, Inc.1999-07-14
EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM) (K983660)Brainlab, Inc.1999-07-14
SPIN SNAP-OFF SCREW (K991477)New Deal, S.A.1999-07-14
26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER (K991622)Stelkast Company1999-07-14
ELECTRO MECHANICAL LITHOTRIPTOR (K990341)Northgate Technologies, Inc.1999-07-14
REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE (K992151)Consolidated Technologies, Inc.1999-07-14
SMITH & NEPHEW SUTURE LOK (K991500)Smith & Nephew Endoscopy, Inc.1999-07-14
SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH. (K991567)Shelhigh, Inc.1999-07-14
CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K991616)Hartalega Sdn Bhd1999-07-14
INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M (K990847)Humagen Fertility Diagnostics, Inc.1999-07-14
THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY (K984563)Accuray, Inc.1999-07-14
PVP (POLYVINYLPYRROLIDONE) (K991343)Irvine Scientific Sales Co., Inc.1999-07-14
COBREX HIP STEM, MODEL 01-128-XXXXX (K991869)Implex Corp.1999-07-14
STRETTA INFLATABLE BASKET CATHETER ELECTRODE WITH ASPIRATION (K991291)Conway Stuart Medical, Inc.1999-07-14
SCLERAL PLUGS, 19 AND 20 GAUGE (K990872)Ophthalmic Consultants, Inc.1999-07-13
ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING (K972772)Trek Diagnostic Systems, Inc.1999-07-13
AT HOME DRUG TEST, MODEL 9175 (K992217)Phamatech1999-07-13
NASO-LARYNGO-PHARYNGOSCOPE (K991560)Fiber Imaging Technologies, Inc.1999-07-13
ULTRAFREE THICK STERILE LATEX POWDER-FREE SURGICAL GLOVES (K991992)Allegiance Healthcare Corp.1999-07-13
ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS (K992163)Pdz-Europa , Ltd.1999-07-13
AHMED GLAUCOMA VALVE IMPLANT (K991072)New World Medical, Inc.1999-07-13
ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS (K991733)Schiapparelli Biosystems, Inc.1999-07-13
PARIETENE POLYPROPYLENE MESH (K991400)Sofradim Production1999-07-12
BODYLOC WHOLE BODY STEREOTACTIC LOCALIZER SYSTEM FOR RADIOTHERAPY (K991336)Medical Instrumentation & Diagnostics Corp.(Midco)1999-07-12
UNI-LASER 450P CO2 LASER SYSTEM & ACCESSORIES (K991297)Medart Corp.1999-07-12
CYNOSURE SURESCAN WITH THE CO3 ER: YAG LASER (K992084)Cynosure, Inc.1999-07-12
SYNERGY POROUS SIZE 8 HIP STEM (K991485)Smith & Nephew, Inc.1999-07-12
LATEX EXAMINATION GLOVE POWDER FREE, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER SOLUBLE PROTEIN) (K992031)Shanghai Changzheng Latex Factory1999-07-12
TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE (K990135)Zimmer, Inc.1999-07-12
CMV BRITE TURBO KIT (K991650)Biotest Diagnostics Corp.1999-07-12
OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HP (K992230)Trimedyne, Inc.1999-07-12
SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING A (K991267)Ohio Medical Instrument Co., Inc.1999-07-12
THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER (K984639)Medison America, Inc.1999-07-12
MEDI-TECH DIALYSIS CATHETER GASTROENTEROLOGY (K982326)Boston Scientific Corp1999-07-12
EARLOOP FACE MASK (K990719)Shuenn Bao Shing Corp.1999-07-12
GE LOGIQ 200 MD DIAGNOSTIC ULTRASOUND SYSTEM (K992208)Ge Medical Systems, Inc.1999-07-12
GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE ECCENTRIC HEAD (K992065)DePuy Orthopaedics, Inc.1999-07-12
ETI-EA-G ASSAY (K992191)DiaSorin, Inc.1999-07-12
TROCAR SYSTEM ACCORDING TO HASSON (K990237)Olympus America, Inc.1999-07-12
PASS/FAIL CHALLENGE PACK (K991276)Propper Mfg. Co., Inc.1999-07-12
TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000 (K982943)Transtracheal Systems1999-07-12
CRYO-HIT,MODELS ED1TO, EPITI, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4,EP5T2, EP5T3, EP5T5, EP6T5,EP7T3,EP7T5,EP8T3,AND E (K991272)Galil Medical , Ltd.1999-07-12
NITRILON CORRECT-TOUCH (K984512)Ct Intl.1999-07-12
VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE (K991303)Vista Medical Technologies, Inc.1999-07-12
LASER SYSTEM RUBYSTAR WITH Q-SWITCH AND NORMAL MODE (K991285)Aesculap-Meditec North America1999-07-12
SCATTERFREE LATERAL EMITTING FIBER (K992083)Laser Peripherals, LLC1999-07-12
BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE (K991300)Dhd Healthcare Corp.1999-07-12
XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40 (K991900)Excel Tech. , Ltd.1999-07-12
BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED) (K991940)Brightway Holdings Sdn. Bhd.1999-07-12
IMMULITE EPO, MODEL #'S LKEPZ & LKEP1 (K983203)Diagnostic Products Corp.1999-07-12
OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET (K991917)Metrika, Inc.1999-07-12
OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER (K991377)Omnisonics Medical Technologies1999-07-12
VELOGENE RAPID MRSA IDENTIFICATION ASSAY (K990640)Id Biomedical Corp.1999-07-09
CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (K991605)Abbott Laboratories1999-07-09
GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS (K990649)Bayer Corp.1999-07-09
POLYMER COAT,POWDER FREE, LATEX EXAMINATION GLOVES (K991624)Smart Glove Corp. Sdn Bhd1999-07-09
CODMAN MICROSENSOR VENTRICULAR CATHETER KIT (K991222)Johnson & Johnson Professionals, Inc.1999-07-09
ACRON MC MODIFICATION (K991774)GC America, Inc.1999-07-09
TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE CASSETTE (K990761)Tuttnauer U.S.A Co, Ltd.1999-07-09
ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS (K991789)Elan Holdings, Inc.1999-07-09
EPTFE RINGED GORE-TEX VASCULAR GRAFT (K991602)W. L. Gore & Associates, Inc.1999-07-09
PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST ST (K983504)Medisense, Inc.1999-07-09
INVACARE CHECK O2 PLUS CONCENTRATOR ANALYZER (CHECK O2 PLUS) (K984295)Invacare Corp.1999-07-09
OPTIBOND SOLO PLUS 2 (K991808)Sybron Dental Specialties, Inc.1999-07-09
SERUM CROSSLAPS ONE STEP ELISA (K990843)Osteometer Biotech A/S1999-07-09
ETCHING GEL (K991450)Silicon-Und Composite Spezialitaten GmbH1999-07-09
GLOVCO, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K991554)Glovco (M) Sdn. Bhd.1999-07-09
ISOLUX SURGICAL HEADLIGHT (K991572)Isolux America1999-07-08
TITANIUM LOW PROFILE SCREWS (K991807)Biomet, Inc.1999-07-08
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