Atlas FDA

1999

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

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RecordFirmDate
FALCON IVF ROUND DISH (K991253)Becton Dickinson Labware1999-05-05
OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE (K990701)Omnigrace (Thailand) , Ltd.1999-05-05
GAS PLASMA STERILIZATION (K972774)Zimmer, Inc.1999-05-05
MODIFICATION TO ULTRA-SELECT GUIDEWIRE (K991194)Microvena Corp.1999-05-05
ARGON MULTI-LUMEN CENTRAL VENOUS CATHETER (K984189)Maxxim Medical1999-05-05
SCANFLEX SOLID COUPLANT MEMBRANE (K983691)Sonotech, Inc.1999-05-05
BROTHERS, VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES (K991085)Long First (Xiamen) Co., Ltd.1999-05-05
CYSTIC DUCT BALLOON DILATING CATHETER (K983154)Applied Medical Resources1999-05-05
CTS-310(B) (K984161)Shantou Institute of Ultrasonic Instuments1999-05-05
LIFEPAK 500 BIPHASIC (K983393)Physio-Control Corp.1999-05-05
ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN (K984496)Atrium Medical Corp.1999-05-05
LATEX EXAMINATION GLOVES POWDERED, LOW PROTEIN (K991043)Glovco (M) Sdn. Bhd.1999-05-04
TA CHIA POWDER FREE NON-STERILE NITRILE PATIENT EXAMINATION GLOVES (K990577)Ta Chia Rubber Ind. Corp.1999-05-04
ORALGIENE TONGUE CLEANER (K990344)Oralgiene USA, Inc.1999-05-04
EDGE SYSTEMS STERILE TUBING (K990748)Edge Systems Corp.1999-05-04
POWDER FREE LATEX EXAMINATION GLOVES (K990686)Tower Rubber Industries Sdn. Bhd.1999-05-04
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED WHITE (K990695)Omnigrace (Thailand) , Ltd.1999-05-04
DBC, DONG BANG ACUPUNCTURE NEEDLES (K990328)Morning Star, Dong Bang Acupuncture U.S.A., Inc.1999-05-04
BROTHERS VINYL, POWDERED, PATIENT EXAMINATION GLOVES (K990946)Long First (Xiamen) Co., Ltd.1999-05-04
POWDER FREE LATEX EXAMINATION GLOVES (K990901)Apl Products Sdn. Bhd.1999-05-04
TA CHIA POWDERED NON-STERILE NITRILE PATIENT EXAMINATION GLOVES (K990575)Ta Chia Rubber Ind. Corp.1999-05-04
POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTA (K990812)Ampri Rubberware Industries Sdn Bhd1999-05-04
ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65 (K990829)Arrow Intl., Inc.1999-05-04
OMNI GRACE LATEX EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED WITH PROTEIN CLAIM (K990702)Omnigrace (Thailand) , Ltd.1999-05-04
SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (K983982)Maxxim Medical1999-05-04
SAS HCG-CHECK (K991193)Sa Scientific, Inc.1999-05-04
SKINSENSE NITRILE POWDER-FREE SYNTHETIC MEDICAL EXAMINATION GLOVE (K984249)London International Group, Inc.1999-05-04
HEMOCHRON RESPONSE (K983475)International Technidyne Corp.1999-05-03
BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME (K990376)Ballard Medical Products1999-05-03
ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT (K990704)Beckman Coulter, Inc.1999-05-03
MODIFICATION TO ABUSCREEN ONLINE BARBITURATES (K983698)Roche Diagnostic Systems, Inc.1999-05-03
B2C, ESPACE REVISION CUP SYSTEM (K990523)Turnkey Intergration USA, Inc.1999-04-30
GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58 (K991032)Guidant Corp.1999-04-30
SINGLE AXLE TOTAL ELBOW (K983036)Biomet, Inc.1999-04-30
ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC (K991223)Aesculap, Inc.1999-04-30
CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS 1644,1644-T,1831,18 (K983610)Intersurgical, Inc.1999-04-30
AU6 (K990360)Biosound Esaote, Inc.1999-04-30
OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY (K984375)Osteonics Corp.1999-04-30
ORTHOPHOS 3/3 CEPH/3 DS (K990528)Sirona Dental Systems GmbH1999-04-30
EXTRACORPOREAL BLOOD CIRCUIT (K982340)Haidylena Medical Egypt1999-04-30
CORDIA PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODEL PC125BPS, PC126BPS, PC127BPS,PC128BPS, PC (K990631)Cordis Corp.1999-04-30
HP M2376A DEVICE LINK SYSTEM (K984194)Hewlett-Packard Co.1999-04-30
SILK SUTURE (K982853)Davis & Geck, Inc.1999-04-30
SPIROVIT, MODEL SP-250 (K984031)Schiller AG1999-04-30
ROTORBLADE (K983435)Li Medical Technologies, Inc.1999-04-29
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM (K991092)Electro-Biology, Inc.1999-04-29
ENDOPEARL (K984171)Linvatec Corp.1999-04-29
THE BAGNOLI-8 EMG SYSTEM (K990356)Delsys, Inc.1999-04-29
IN TOUCH DIABETES MANAGEMENT SOFTWARE (K984527)Lifescan, Inc.1999-04-29
HI-TORQUE BALANCE TREK GUIDE WIRE (K991152)Guidant Corp.1999-04-29
ORLIGHT 2000 SURGICAL LASER SYSTEM (K990452)Ybeam Technologies, Inc.1999-04-29
STAYFUSE (K990804)Pioneer Surgical Technology1999-04-29
HYDRO-CAST ACRYLIC VARNISH, MODEL 78125 (K991161)Kay See Dental Mfg. Co.1999-04-29
PROVIDENCE CUP SYSTEM (K990821)Biopro, Inc.1999-04-29
SOFT TISSUE SUTURE WASHER (K991135)Depuy, Inc.1999-04-29
BOLD SCREW (K990622)New Deal, S.A.1999-04-29
BUECHEL-PAPPAS MODULAR SALVAGE STEM (K982418)Endotec, Inc.1999-04-29
EBI OMEGA 21 SYSTEM (K990303)Electro-Biology, Inc.1999-04-29
QUINTON MEDTRACK CR PLUS TREADMILL (K990866)Quinton, Inc.1999-04-29
AAP CANNULATED SCREW, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM (K990776)Aap Implantate AG1999-04-29
OPTICAL TRACKING SYSTEM (OTS) (K990632)Radionics, Inc.1999-04-29
KENSTONE (K990139)Kenda USA1999-04-29
SPECTRA VU 1000 SERIES INTRAORAL CAMERA, SPECTRA VU 2000 SERIES INTRAORAL CAMERA, SPECTRA VU HDDI SV I INTRAORAL CAMERA, (K984332)International Technology Concepts1999-04-29
FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER (K990906)Ferris Mfg. Corp.1999-04-29
DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM (K990596)Avanta Orthopaedics, Inc.1999-04-29
AUTOSTAT II ANTI-SM/RNP ELISA (K990624)Cogent Diagnotics , Ltd.1999-04-28
AUTOSTAT II ANTI-JO-1 ELISA (K990798)Cogent Diagnotics , Ltd.1999-04-28
DAUM NEUROGATE TROCAR (K990782)Daum GmbH1999-04-28
AUTOSTAT II ANTI-SS-B/LA ELISA (K990626)Cogent Diagnotics , Ltd.1999-04-28
AUTOSTAT II ANTI-SCL-70 ELISA (K990797)Cogent Diagnotics , Ltd.1999-04-28
WATER TREATMENT SYSTEM FOR HEMODIALYSIS (K983512)Water Vault, Inc.1999-04-28
AUTOSTAT II ANTI-SS-A/RO ELISA (K990627)Cogent Diagnotics , Ltd.1999-04-28
TRINITY II SINGLE CHAMBER DVT PUMP (K983680)Delphi Consulting Group1999-04-28
QUICKCARD HCG COMBO TEST, MODEL #9014 (K991095)Phamatech1999-04-28
AUTOSTAT II ANTI-SM ELISA (K990625)Cogent Diagnotics , Ltd.1999-04-28
STAINLESS STEEL NONABSORBABLE SURGICAL SUTURE, USP (K984151)Mill Pond, Inc.1999-04-28
AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA (K990796)Cogent Diagnotics , Ltd.1999-04-28
KERAVISION VACUUM RING SYSTEM (K984540)Keravision, Inc.1999-04-28
MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015 (K990333)Medtronic PS Medical1999-04-28
GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR (K991411)Gereonics, Inc.1999-04-28
BLOOD PRESSURE METER, MODELS CH-491, CH-481, CH-471 (K984223)Citizen Watch Co., Ltd.1999-04-28
MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5 (K991277)Diagnostic Products Corp.1999-04-27
MODIFICATION OF: DAVIDSTRIP HCG (K991067)Simex Medical, Inc.1999-04-27
REDI-TEST THC (K990870)Redwood Biotech, Inc.1999-04-27
EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816 (K990971)Medica Corp.1999-04-27
PILLING WECK SURGICAL Y STENT FORCEPS (K990547)Pilling Weck, Inc.1999-04-27
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS (K983711)Dade Microscan, Inc.1999-04-27
MODIFIED VERSAPULSE SELECT SINGLE WAVELENGTH, HO: YAG AND DUAL WAVELENGTH, HO: YAG/ND: YAG SURGICAL LASERS AND DELIVERY (K990947)Lumenis, Inc.1999-04-27
ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10 (K990610)Bio-Rad1999-04-27
LATEX EXAMINATION GLOVE W/ LOW PROTEIN LABELING (K990468)Top Glove Sdn. Bhd.1999-04-27
X-TIP INTRAOSSEOUS PERFORATOR (K990511)Schiff & Co.1999-04-27
RENU MULTIPLUS MULTI-PURPOSE SOLUTION (K990422)Bausch & Lomb, Inc.1999-04-27
EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL DUAL BREAST PUMP (K983776)Evenflo Co., Inc.1999-04-26
SPERM WASHING MEDIUM, MODIFIED SPERM WASHING MEDIUM (K983588)Irvine Scientific Sales Co., Inc.1999-04-26
VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX CANNULATED BONE SCREW (K991151)Vilex, Inc.1999-04-26
VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW, MODELS P222-XX, S25-XX, P227-XX, S30-XX, P235-XX, S35-XX, P240-XX, S40-XX, P24 (K991197)Vilex, Inc.1999-04-26
EZFLOW CONTINUOUS NEBULIZER,MODEL 1005 (K990384)Piper Medical Products1999-04-26
RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS (K990327)Coulter Corp.1999-04-26
CAVIT LC (K990982)Espe Dental AG1999-04-23
MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM (K991294)Medi-Ject Corp.1999-04-23
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