Atlas FDA

1999

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

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RecordFirmDate
IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6 (K990222)Diagnostic Products Corp.1999-02-26
BIRTCHER UV LAMP (K973865)Medfaxx, Inc.1999-02-26
ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544, ONTRAK TESTCUP M2K AND ONTRAK TESTSTICK NEGATIV (K990377)Roche Diagnostics Corp.1999-02-26
SURE (K982380)Pleasure Latex Products Sdn. Bhd.1999-02-26
FLEXART,FLEXART/HYPER, VISART, VISART/HYPER (K983110)Toshiba America Mri, Inc.1999-02-25
GLUMA ONE BOND (K990143)Heraeus Kulzer, Inc.1999-02-25
ENDO ANALYZER, MODEL 8005, MODIFIED (K990225)Sybron Dental Specialties, Inc.1999-02-25
HYBRISONIC SHEATH (K983985)Sonotech, Inc.1999-02-25
HYDRO-CAST VERSA-TEMP NON-EUGENOL PROVISIONAL CEMENT, MODEL 70010 (K990155)Kay See Dental Mfg. Co.1999-02-25
MICROLIFE IT2CA1 (K990168)Microlife Systems AG1999-02-25
GC UNIFAST TRAD (K984365)GC America, Inc.1999-02-25
SOLO PLUS ORTHO (K990252)Sybron Dental Specialties, Inc.1999-02-25
ELIPAR TRILIGHT (K984247)Espe Dental AG1999-02-25
RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS (K984545)Philips Medical Systems North America, Inc.1999-02-25
FREE FLOW SAFETY DEVICE, MODEL MG 245052 (K990288)Teva Medical, Ltd.1999-02-24
SABRATEK 4040 INFUSION PUMP (K980751)Sabratek Corp.1999-02-24
SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM (K983648)Perry Baromedical Services1999-02-24
MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE (K984310)Moss Tubes, Inc.1999-02-24
ERCO-RIBBON -C (K990008)Ercons, Inc.1999-02-24
XIA SPINE SYSTEM (K984251)Howmedica, Inc.1999-02-24
BIPOLAR GRASPING FORCEPS BIQ+ (K984417)Olympus America, Inc.1999-02-24
MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR (K990223)Unipath , Ltd.1999-02-24
MODIFICATION OF MILLENNIUM (K990219)Biolase Technology, Inc.1999-02-24
OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE (K984585)Osteonics Corp.1999-02-24
J-SERIES OMEGA TOTAL HIP SYSTEM (K990003)Osteoimplant Technology, Inc.1999-02-24
PREPARE HOME INFUSION PUMP (K983634)Medical Infusion Technologies, Inc.1999-02-24
LAGLOVE BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE) (K990268)La Glove (M) Sdn. Bhd.1999-02-24
ERCO-VAC -C (K990006)Ercons, Inc.1999-02-24
FLEXPOSURE RETRACTOR (K983144)Endius, Inc.1999-02-24
MODIFICATION OF VENTURI VENTILATOR (K990429)Cardiopulmonary Corp.1999-02-24
DALL-MILES CABLE GRIP (A-GRIP) (K984432)Howmedica Osteonics Corp.1999-02-24
FUSICRYL (K984467)Micro Dental Laboratories1999-02-24
HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0) (K980386)Gambro Healthcare1999-02-24
ECHELON HIP STEM (K983834)Smith & Nephew, Inc.1999-02-24
INFANT FLOW NCPAP MASKS (K984254)Sensor Medics Corp.1999-02-24
LINEAR ARRAY TRANSDUCER,MODEL HP 21376, M2410A ULTRASOUND IMAGING SYSTEM (K990400)Hewlett-Packard Co.1999-02-24
ONTRAK TESTCUP-5 M2K (K990337)Roche Diagnostics Corp.1999-02-23
MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH (K984220)ETHICON, Inc.1999-02-23
OASIS THROMBECTOMY CATHETER SYSTEM (K982363)Boston Scientific Corp1999-02-23
RELIEFBAND MST DEVICE, MODELS RB-2, RB-6, RB-R (K982967)Woodside Biomedical, Inc.1999-02-23
FEMOSTOP COMPRESSION ARCH, FEMOSTOP PUMP, FEMOSTOP BILATERAL ADAPTER (K983471)Radi Medical Systems AB1999-02-23
ORL-E-92 SURGICAL DRILL SYSTEM (K984244)Bien Air USA, Inc.1999-02-23
BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT (K984619)The Binding Site, Ltd.1999-02-23
NORMLGEL 0.9% ISOTONIC SALINE GEL (K984368)Molnlycke Health Care, Inc.1999-02-22
FACT PLUS ONE STEP PREGNANCY TEST (K990373)Abbott Laboratories1999-02-22
(1) DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-250; (2) FULLY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL MD-700 (K990380)Meditec Co., Ltd.1999-02-22
MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES (K984294)Intervascular, Inc.1999-02-22
PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER (K984150)Ep Medsystems1999-02-22
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (K983208)Wallach Surgical Devices, Inc.1999-02-22
SILVERLON ISLAND DRESSING, SILVERLON ISLAND PAD (K984208)Argentum International, LLC1999-02-22
KVO CHECK VALVE ACCESSORY, MODEL EV-0001 (K984441)I-Flow Corp.1999-02-22
SIGNA 1.5T PHOSPHORUS (P) TRANSMIT/RECEIVE FLEX COIL (K983139)GE Medical Systems1999-02-19
PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM (K983314)Nycomed Amersham Imaging1999-02-19
HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000 (K982867)Davol Inc., Sub. C. R. Bard, Inc.1999-02-19
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE (K990117)Shanghai Palomar Mountain Industries, Inc.1999-02-19
NITRILE POWDER FREE EXAMINATION GLOVES (K983334)Cranberry (M) Sdn. Bhd.1999-02-19
HUMMER TRAK SYSTEM (K990038)Stryker Endoscopy1999-02-19
SHEER GLYDE DAMS (K990067)Louise C. Myers1999-02-19
GUTHRIE PRIME POWDER-FREE (K990228)Guthrie Medicare Products (Melaka) Sdn Bhd1999-02-19
TEL-ECHO SYSTEM (K990052)Innovative Medical Solutions, Inc.1999-02-19
BURETROL SOLUTION SETS (K984381)Baxter Healthcare Corp1999-02-19
E-FAX SYSTEM (K982034)Blakbag, Ltd., Division of Coherent Systems1999-02-19
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDERED (K990081)Shanghai Palomar Mountain Industries, Inc.1999-02-19
THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED IMMUNOSORBENT ASSAY FOR THE DETECTION OF THE S (K984544)Enteric Products, Inc.1999-02-18
HTF MEDIUM, MODIFIED HTF MEDIUM- HEPES, HTF POWDER (WITHOUT ANTIBIOTICS), MODIFIED HTG POWDER- HEPES (WITHOUT ANTIBODITI (K983586)Irvine Scientific Sales Co., Inc.1999-02-18
P-1 (PREIMPLANTATION STAGE ONE) MEDIUM (K983589)Irvine Scientific Sales Co., Inc.1999-02-18
BLASTOCYST MEDIUM (K983580)Irvine Scientific Sales Co., Inc.1999-02-18
KMI WRIST FUSION SYSTEM (K990094)Kinetikos Medical, Inc.1999-02-18
CROSSTEX NON-WOVEN SPONGES (K984187)Crosstex Intl.1999-02-18
SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM (K984498)Synthes (Usa)1999-02-18
WIDE BODY ABUTMENTS (K984198)Vident1999-02-18
LATERALIZED INTERGRAL POROUS PRIMARY FEMORAL COMPONENT (K984296)Biomet, Inc.1999-02-18
A-SOFT RELINER (K984483)S & C Polymer GmbH1999-02-18
ANATOMICA HUMERAL STEM/HEAD COMPONENTS (K990137)Sulzer Orthopedics, Inc.1999-02-18
MODULAR PROTUSIO CUP (K990032)Biomet, Inc.1999-02-18
FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM (K980689)Friddle'S Orthopedic Appliances, Inc.1999-02-18
SYSTEM U3 (K983890)Ab Biodisk1999-02-18
BAHO AUTOCLAVABLE LAPAROSCOPE (K982276)Microptix Int'L, LLC1999-02-18
LAGLOVE BRAND LATEX EXAMINATION GLOVES (LOW PROTEIN) (K990285)La Glove (M) Sdn. Bhd.1999-02-18
LAGLOVE BRAND LATEX EXAMINATION GLOVE (POWDER FREE) (K990270)La Glove (M) Sdn. Bhd.1999-02-18
ACTITORIC (OCUFILCON A) SOFT (HYDROPHILIC) TORIC CONTACT LENS FOR DAILY WEAR (K983160)Hydron , Ltd.1999-02-18
PRONOSCO X-POSURE SYSTEM (K984178)Torsana Osteoporosis Diagnostics A/S1999-02-18
MEDART 455 SCANNER SYSTEM (K984339)Del Mar Technologies, Inc.1999-02-18
SONOS 5500 IMAGING SYSTEM M2424A VERSION B.O (K990339)Hewlett-Packard Co.1999-02-18
OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS (K990203)Osteonics Corp.1999-02-18
GLIADIN ANTIBODIES ELISA (K973910)Genesis Diagnostics , Ltd.1999-02-17
CARE BAND ANTIBACTERIAL BANDAGES (K983368)Aso Corp.1999-02-17
POWDERED NITRILE EXAMINATION GLOVES (K984615)Shiva Medicare , Ltd.1999-02-17
BIPORE BALLOON DILATATION CATHETER (K983650)Bipore, Inc.1999-02-17
PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA (K990046)Pacific Hemostasis1999-02-17
BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR FIXATION SYSTEM (K982721)Bionx Implants, Inc.1999-02-17
EXONIX (K984199)Fibra Sonics, Inc.1999-02-17
CBC-5D HEMATOLOGY CONTROL (K983032)R&D Systems, Inc.1999-02-17
INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST (K984079)Alfa Scientific Designs, Inc.1999-02-16
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES (K984489)Accumed Intl., Inc.1999-02-16
INSTANT-VIEW PREGNANCY COMBO DIP-STRIP TEST (K984080)Alfa Scientific Designs, Inc.1999-02-16
INSTANT-VIEW PREGNANCY COMBO TEST (K984077)Alfa Scientific Designs, Inc.1999-02-16
THE FREMSTAD RING (K982599)Ophthalmic Solutions, LLC1999-02-16
INSTANT-VIEW PREGNANCY URINE TEST (K984076)Alfa Scientific Designs, Inc.1999-02-16
DIMENSION DRUG CALIBRATOR II, MODEL DC49B (K990255)Dade Behring, Inc.1999-02-16
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