Atlas FDA

2000

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

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RecordFirmDate
RHIGENE MESACUP2 TEST- SCL-70 (K000750)Rhigene, Inc.2000-05-09
NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240 (K994140)Nichols Institute Diagnostics2000-05-09
RHIGENE MESACUP2 TEST- SSB (K000751)Rhigene, Inc.2000-05-09
PSK ENDOSCOPE CLEANING SYSTEM (K000216)Psk Connectors Pty, Ltd.2000-05-09
RHIGENE MESACUP2 TEST- RNP (K000752)Rhigene, Inc.2000-05-09
POWDER FREE STERILE LATEX EXAMINATION GLOVES (K001141)Allegiance Healthcare Corp.2000-05-09
GO MEDICAL BALLOON INFUSION SYSTEM (K000263)Go Medical Industries Pty. , Ltd.2000-05-09
MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP (K000328)Medex, Inc.2000-05-09
EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I (K001241)The Olympus Optical Co.2000-05-09
VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES (K000457)Retinalabs.Com2000-05-09
MEDI-CULT EMBRYO FREEZING MEDIUM INTERNAL CATAGLOG NUMBERS 1079 (K991472)Medicult A/S2000-05-09
TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001 (K000416)Retinalabs.Com2000-05-08
SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003 (K000420)Retinalabs.Com2000-05-08
BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT (K991802)The Binding Site, Ltd.2000-05-05
YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGMACAM INTRAORAL CAMERA (K000577)The Yoshida Dental Mfg. Co., Ltd.2000-05-05
BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT (K991801)The Binding Site, Ltd.2000-05-05
CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE (K000897)Bd Biosciences2000-05-05
DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP (K994243)Heartport, Inc.2000-05-05
CARTO EP NAVIGATION SYSTEM (K000248)Biosense Webster, Inc.2000-05-05
THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES (K993678)Haemoscope Corp.2000-05-05
EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR (K991293)Fischer Medical Technologies, Inc.2000-05-05
BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT. (K991803)The Binding Site, Ltd.2000-05-05
BINDAZYME ANTI-B2 SCREEN EIA TEST KIT. (K991804)The Binding Site, Ltd.2000-05-05
PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601 (K000734)Pioneer Surgical Technology2000-05-05
ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS (K001144)Lasersight Technologies, Inc.2000-05-05
VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 (K001310)Ortho-Clinical Diagnostics, Inc.2000-05-05
CONNECT DATA MANAGEMENT SYSTEM (K994433)Abbott Diabetes Care, Inc.2000-05-05
SERIM LEUKOCYTE ESTERASE TEST STRIPS (K000578)Serim Research Corp.2000-05-05
SYNCHRON SYSTEMS AMPHETAMINE REAGENT (K000606)Beckman Coulter, Inc.2000-05-05
POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111 (K000386)Medtronic Functional Diagnostics A/S2000-05-05
BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH (K001100)Cardiodynamics International Corp.2000-05-05
MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PRE-ATTACHED NEEDLE (K001293)Medimop Medical Projects, Ltd.2000-05-05
MODIFICATION TO CARTO EP NAVIGATION SYSTEM (K000190)Biosense Webster, Inc.2000-05-05
SHARPLAN LASERS, INC. PULSED CTH:YAG HOLMIUM SURGICAL LASER, MODEL 2040 (K001263)E S C Sharplan2000-05-05
DIRECT TIBC CALIBRATOR (K000783)Reference Diagnostics, Inc.2000-05-04
MULTI-PULSE 2000 (K001248)Imaging Sciences Intl., Inc.2000-05-04
VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT CHISELS, VULCAN EFLEX LIGAMENT CHISELS (K000691)Oratec Interventions, Inc.2000-05-04
MEDI-CULT SPERM PREPARATION - MEDIUM; (K991332)Medicult A/S2000-05-04
CEMSTOP CEMENT RESTRICTOR (K993841)Encore Orthopedics, Inc.2000-05-04
MODULAR-PLUS REVISION STEM (K994126)Plus Orthopedics2000-05-04
NOGA CARDIAC NAVIGATION SYSTEM (K000332)Biosense Webster, Inc.2000-05-04
EYECAP IMAGING SYSTEM (K000368)Clement Clarke Intl., Ltd.2000-05-04
SHUTTLE STOP (K000587)Isotis NV2000-05-04
SHARP BRAND ACUPUNCTURE NEEDLES (K000816)Tcm Supply Corp.2000-05-04
SIMPLEX AIRBRATOR (SAB-7) (K980672)Irt Management Corp.2000-05-04
KAVO K.E.Y. LASER 1242 (K000805)Kavo America2000-05-04
HTF-HEPES (K000939)Invitrocare, Inc.2000-05-04
MEDI-CULT FLUSHING MEDIUM (K991327)Medicult A/S2000-05-04
HUMAN SERUM ALBUMIN (HSA) (K000940)Invitrocare, Inc.2000-05-04
A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000 (K992592)A-Med Systems, Inc.2000-05-04
BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD (K993816)Baxter Edwards2000-05-04
FOTOMASTER (K000380)Hamilton Thorne Research2000-05-03
AU5, AU6 (K000681)Biosound Esaote, Inc.2000-05-03
CLINI-DENT (K000140)The Precident Group2000-05-03
COLORADO MICRODISSECTION NEEDLE (K000348)Stryker Leibinger2000-05-03
MOTORIZED MICRO MULTILEAF COLLIMATOR (K000349)Stryker Leibinger2000-05-03
AGILENT INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A AND AGILENT M2/M3/M4 COMPACT PORTABLE PATIENT MONITOR (K001057)Agilent Technologies, Inc.2000-05-03
MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORM (K001153)Medtronic Surgical Navigation2000-05-03
GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY : 451006-4; CABLES: 451102-4 (K001083)Boston Scientific, Target2000-05-03
MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSER (K000438)Biosurgical Corp.2000-05-03
STANDARD & EXTENDED BLADE, STANDARD & EXTENDED NEEDLE, STANDARD & EXTENDED BALL, MODIFIED STANDARD & EXTENDED BLADE, MOD (K000333)Triad Surgical Technologies, Inc.2000-05-03
IDS5 IMAGE DISPLAY SYSTEM (K001140)Sectra AB2000-05-03
LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM (K001238)Walter Lorenz Surgical, Inc.2000-05-03
ENTEC REFLEX WAND 55, MODEL E4055-01, E4045-01 (K000778)Arthrocare Corp.2000-05-03
4631 DUO DELIVERY SYSTEM (K000966)A-Dec, Inc.2000-05-03
POWDER-FREE NITRILE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) (K991422)Shen Wei (Usa), Inc.2000-05-03
SENSI GRIP LATEX EXAMINATION GLOVE, POWDERED CONTAINS 200 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM (K000745)Tillotson Healthcare Corp.2000-05-03
TEMPO AQUA ANGIOGRAPHIC CATHETER (K000579)Cordis Corp.2000-05-03
DIMAX 2 (K000771)Planmeca Oy2000-05-03
EINSTEIN PROCESSING AND REVIEW WORKSTATION (K000395)Ge Medical Systems F.I. Haifa2000-05-03
ATR TECNIKA (K000547)Advanced Technology Research (A.T.R.) S.R.P.2000-05-03
3181 DUO DELIVERY SYSTEM (K000968)A-Dec, Inc.2000-05-03
H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS (K993520)Serv-A-Pure Co.2000-05-03
POWDERFREE LATEX SURGEON'S GLOVES WITH PROTIEN LABELING CLAIM (50 MOCROGRAMS OR LESS (K000896)Fitco Dipped Products Pvt., Ltd.2000-05-03
4635 ASSISTANT'S INSTRUMENTATION (K000967)A-Dec, Inc.2000-05-03
ACTIVE ELECTRODE MONITORING SYSTEM (K000480)Electroscope, Inc.2000-05-02
WAVESCAN WAVEFRONT SYSTEM MODEL HS 1 (K000327)Visx, Incorporated2000-05-02
CEDIA DAU AMPHASSURE ASSAY (K994380)Microgenics Corp.2000-05-02
TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER (K000665)Tfx Medical, Inc.2000-05-02
ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS (K000900)Elan Holdings, Inc.2000-05-02
HELIODENT VARIO (K000672)Sirona Dental Systems GmbH2000-05-02
SONOS AIRES 600 (SA-600) (K000320)Kpi Ultrasound, LLC2000-05-02
SHELHIGH NO-REACT DURA SHIELD (K982101)Shelhigh, Inc.2000-05-02
KRONNER LOW PROFILE SCOPE HOLDER (K000663)Kronner Prototypes, Inc.2000-05-02
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA (K001266)Ortho-Clinical Diagnostics, Inc.2000-05-02
DIRECT TIBC KIT (K000781)Reference Diagnostics, Inc.2000-05-02
SENTRY EXPANDING INTRODUCER SHEATH (EIS) (K000545)Applied Medical Resources2000-05-02
GLUCANPRO (K000519)Brennen Medical, Inc.2000-05-01
BONE BIOPSY NEEDLE (K001132)Promex, Inc.2000-05-01
RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO (K001079)Arjo, Inc.2000-05-01
SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM (K000682)Synthes (Usa)2000-05-01
A100 AESTHETIC DIODE LASER (K000982)Diomed, Inc.2000-05-01
MACROPRO GEL (K000518)Brennen Medical, Inc.2000-05-01
BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B (K000506)Arthrex, Inc.2000-05-01
MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500 (K001085)Nonin Medical, Inc.2000-05-01
POWDER-FREE NON-VHLORINATED POLYMER COATED LATEX EXAMINATION GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRA (K000668)Protection Gloves Sdn. Bhd.2000-04-28
PERITONEAL DIALYSIS CATHETERS AND ADAPTERS (K993149)Medionics International, Inc.2000-04-28
DIXI 2 (K000428)Planmeca Oy2000-04-28
EZ CONNECT RESIN (K000357)Kerr Dental Materials Center2000-04-28
CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK (K993619)Sims Portex, Inc.2000-04-28
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