Atlas FDA

2000

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

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RecordFirmDate
NIPRO BLOOD COLLECTION NEEDLE (K992699)Nipro Medical Corp.2000-02-14
LCV+ VERSION 2 (K993037)Ge Medical Systems, Inc.2000-02-14
PERMA-DOC PHANTOM (K993960)Mick Radio-Nuclear Instruments, Inc.2000-02-14
VEIN ENTRY INDICATOR DEVICE (VEID) (K993995)Vascular Technologies , Ltd.2000-02-14
ISSA PHAROS (K994054)Vams Tec, D.O.O.2000-02-14
HARDYDISK GENTAMICIN, 10MCG (K994091)Hardy Diagnostics2000-02-11
EXETER CERAMIC FEMORAL HEADS (K993889)Howmedica Osteonics Corp.2000-02-11
AUDIOSCREENER OAE (K000184)Kedly, Inc.2000-02-11
HARDYDISK CEFIXIME, 5MCG (K994129)Hardy Diagnostics2000-02-11
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS (K991397)Sein Electronics Co., Ltd.2000-02-11
CAVERMAP SURGICAL AID (K993436)Uromed Corp.2000-02-11
HARDYDISK CHLORAMPHENICOL, 30MCG (K994089)Hardy Diagnostics2000-02-11
KODAK HOME HEALTH MONITORING SYSTEM (K983928)Eastman Kodak Company2000-02-11
T-GEAR, MODEL TG/400-700 (K993224)Dontech Products B.V.2000-02-11
GASTRO-INTESTINAL SYSTEM EN-410WM (K993704)Fujinon, Inc.2000-02-11
CARD GUARD PERSONAL ELECTROCARDIOGRAM TRANSMITTER, MODEL CG-6206/6306 (K000225)Card Guard Scientific Survival , Ltd.2000-02-11
CAP PORP, CAP TORP (K000256)Gyrus Ent LLC2000-02-11
NIPRO INSULIN SYRINGE (K000144)Nipro Medical Corp.2000-02-11
PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E, PARSET SECONDARY SECONDARY ADMINISTRATION SET, MODEL A1400 (K000017)Rd Medical Mfg., Inc.2000-02-10
EASY CARE AND TUBING SETS (K994218)Medionics International, Inc.2000-02-10
COPALIS RUBELLA IGM (K993291)DiaSorin, Inc.2000-02-10
PR3 ULTRASOUND SYSTEM (K993978)Carolina Medical, Inc.2000-02-10
ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS) (K993190)Surgical Instrument Systems (Sis), Ltd.2000-02-10
OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS (K994435)Jeneric/Pentron, Inc.2000-02-10
HORIZON MEDICAL PRODUCTS MICROPORT 2 PERIPHERAL ACCESS PORT SYSTEM (K994196)Horizon Medical Products, Inc.2000-02-10
EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE (K000274)Medtronic Cardiac Surgical Products2000-02-10
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER (K000101)Guidant Corp.2000-02-10
MEDX INTECAM INTERFACE (K993893)Medx, Inc.2000-02-10
EXEL I.V. BLOOD LINE SET (K992039)Exelint Intl. Co.2000-02-10
MU PLUS (K992689)Rad Therapy Solutions, Inc.2000-02-10
ULTRABLATOR ELECTRODE (K993885)Linvatec Corp.2000-02-10
IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM (K992467)Dba Systems, Inc.2000-02-10
I-STAT SYSTEM (K992571)I-Stat Corp.2000-02-10
R1000 SERIES INSULIN PUMP (K993184)Animas Corp.2000-02-10
HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION (K993918)Pamitex Industries Sdn Bhd2000-02-10
NASOGASTRIC TUBE HOLDER, MODEL 160 (K994300)Dale Medical Products, Inc.2000-02-10
BACT/ALERT SV (K994343)Organon Teknika Corp.2000-02-10
EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL (K992176)St. George Technology, Inc.2000-02-10
SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR (K000331)Beckman Coulter, Inc.2000-02-10
YEASTEST (K993554)Diagnostic Markers, Inc.2000-02-10
GUTHRIE PRIME POWDER-FREE CHLORINATED PATIENT EXAMINATION GLOVES (K000090)Guthrie Medicare Products (Melaka) Sdn Bhd2000-02-10
X-RAY MONOBLOCK, MONOBLOCK XRS-60-330 (K000052)Dynarad Corp.2000-02-10
FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FCR 5501D DUAL SIDE READER (K993861)Fujifilm Medical System U.S.A., Inc.2000-02-10
DATEX-OHMEDA INOVENT DELIVERY SYSTEM (K000186)Datex-Ohmeda2000-02-10
UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE (DEN000002)Urosurge, Inc.2000-02-09
SHANGHAI POSEIDON POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW (K992979)Shanghai Poseidon Plastic Products Co., Ltd.2000-02-09
BIOTEQUE HEMODIALYSIS BLOOD TUBING SET (K992930)Bioteque Corp.2000-02-09
POWERED DENTAL POWDERED EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (75 MICROGRAMS OR LESS) (K994162)Allegiance Healthcare Corp.2000-02-09
AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES (VIOLET, BLUE, GREEN AND PINK), WITH PROTEIN CONTENT LABELING CLAIM (50 MI (K993912)Latexx Partners, Inc.2000-02-09
POLYGLYCOLIC ACID (K994001)Trading Consultants and Distributors Intl., Inc.2000-02-09
AUTODOSE INFUSION SYSTEM, MODEL AD4120, BE4210, S12050,100,200, FF0005, 10 (K993832)Tandem Medical, Inc.2000-02-09
HSV-1 ELISA IGG, MODEL EL0910G (K993754)Mrl Diagnostics2000-02-09
FRONTAL SINUS TREPHINATION CANNULA (K994262)Xomed, Inc.2000-02-08
CEREC 3 (K994172)Sirona Dental Systems GmbH2000-02-08
GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150 (K000102)Teco Diagnostics2000-02-08
ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINE (K993818)California Medical Laboratories, Inc.2000-02-08
BITX PROBES (K994336)Everest Medical Corp.2000-02-08
CLICK'X (K992739)Synthes Spine2000-02-08
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K000094)Medtronic Sofamor Danek USA, Inc.2000-02-08
SUTRASILK SILK SUTURE (K994177)Visionary Medical Supplies, Inc.2000-02-08
SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T (K994191)Nmt Medical, Inc.2000-02-08
SUTRALON NYLON SUTURES (K994176)Visionary Medical Supplies, Inc.2000-02-08
ARTHRO-SURGIMAT-A103 (K000153)W.O.M. World of Medicine GmbH2000-02-08
TEKMEDIC POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (K994250)Tekmedic (M) Sdn Bhd2000-02-07
DISPOSABLE INFUSION PUMP KIT (K993972)Biomet, Inc.2000-02-07
ARABESK FLOW (K994304)Voco GmbH2000-02-07
AMBIDERM POWDERFREE LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM OF 50 MICROGRAMS OR LESS PER GRAM (BLACK COLORED) (K994131)Medtaxx Partners2000-02-07
SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLOR (K994222)Shijiazhuang Hongray Plastic Products Co., Ltd.2000-02-07
PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMPONS (K993794)Playtime Products, Inc.2000-02-07
GYNECARE LAPAROSCOPIC MORCELLATOR (K993801)ETHICON, Inc.2000-02-07
POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (K993876)Shen Wei (Usa), Inc.2000-02-07
SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLOR (K994206)Shijiazhuang Hongray Plastic Products Co., Ltd.2000-02-07
LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE (K994255)Pt. Maja Agung Latexindo2000-02-07
NOVABONE-BIOGLASS BONE GRAFT PARTICULATE (K000149)Usbiomaterials Corp.2000-02-07
RESIN TOOTH BONDING AGENT (K994302)Parkell, Inc.2000-02-07
RUBBERCARE POWDER-FREE, GUARDIAN POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (K994201)Perusahaan Pelindung Getah (M) Sdn Bhd2000-02-07
HUMAN SERUM ALBUMIN (K991392)Advanced Reproductive Technologies2000-02-07
ARTIFICIAL TEETH (ACRYLIC TEETH) (K992854)Masterdent Ltda.2000-02-07
PAR 5 ACETABULAR COMPONENT (K000254)Biomet, Inc.2000-02-07
THE MARGRON HIP REPLACEMENT SYSTEM (K992815)Portland Orthopaedics Pty. , Ltd.2000-02-07
KSEA RIGID CULDOSCOPE AND ACCESSORIES (K993804)KARL STORZ Endoscopy-America, Inc.2000-02-07
EXCELART WITH PIANISSIMO (K993803)Toshiba America Mri, Inc.2000-02-06
ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES) (K992805)Oratec Interventions, Inc.2000-02-04
ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285 (K994211)Dentsply Intl.2000-02-04
SILK (K993999)Trading Consultants and Distributors Intl., Inc.2000-02-04
PLAIN/CHROMIC CATGUT (K994002)Trading Consultants and Distributors Intl., Inc.2000-02-04
ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROUS HIP WITH HA, ENCORE REVELATION POROUS HIP WITH HA (K993943)Encore Orthopedics, Inc.2000-02-04
KAC-63 KNEE ARRAY COIL (K993898)Mri Devices Corp.2000-02-04
POLYPROPYLENE (K993997)Trading Consultants and Distributors Intl., Inc.2000-02-04
VITALOGRAPH MICRO (K991412)Vitalograph, Inc.2000-02-04
MR ENHANCER (K994117)I.Z.I. Corp.2000-02-04
QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04 (K000131)Phamatech2000-02-04
WILTSE SYSTEM (K992012)Advanced Spine Fixation Systems, Inc.2000-02-04
KARL STORZ AUTOCLAVABLE CAMERA HEAD (K994090)Karl Storz Imaging, Inc.2000-02-04
BARCOMED 2MP2 (K000015)Barco N.V.2000-02-04
ULTRACLIP TISSUE MARKER (K993785)Inrad2000-02-04
SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C (K993834)Cardiofocus, Inc.2000-02-04
POROCOAT PRODIGY HIP PROSTHESIS (K000207)DePuy Orthopaedics, Inc.2000-02-04
ACUMED MODULAR SHOULDER SYSTEM (K992525)Acu Med, Inc.2000-02-04
I.CO.S SCREW (K993762)New Deal, S.A.2000-02-04
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