Atlas FDA

1999

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

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RecordFirmDate
MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM (K990220)Medi-Globe Corp.1999-03-31
VEGA RETIC AUTOMATED HEMATOLOGY ANALYZER (K990311)Abx Diagnostics1999-03-31
ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (K990516)Emd Chemicals, Inc.1999-03-31
COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT LENS (K990264)Metro Optics of Austin, Inc.1999-03-31
BOJRAB MICRO-TORP, MODEL 7014-5845 (K990601)Gyrus Ent LLC1999-03-31
MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM (K990745)Synthes Spine1999-03-30
INDIGO LASEROPTIC TREATMENT SYSTEM (K990851)Indigo Medical, Inc.1999-03-30
ARCHITECT CEA MASTERCHECK, MODEL 6CO2-05 (K990608)Bio-Rad1999-03-30
COOPERSURGICAL INFRARED COAGULATOR FOR ENT (K990855)CooperSurgical, Inc.1999-03-30
LPULSA SYL-9000 OPHTHALMIC YAG LASER (K990075)Light-Med(Usa), Inc.1999-03-30
VIEWPOINT MICROSCOPE OPTION (K990860)Philips Medical Systems (Cleveland), Inc.1999-03-30
SPOROX II STERILIZING & DISINFECTING SOLUTION (K990703)Reckitt Benckiser, Inc.1999-03-30
ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM (K982660)Transfusion Technologies Corp.1999-03-30
DAUM NEUROCUT NEUROBIOPSYNEEDLE (K990278)Daum Corp.1999-03-30
VIEWPOINT PASSIVE TOOL OPTION (K990868)Philips Medical Systems (Cleveland), Inc.1999-03-30
SAPHLIFT (K990062)Genzyme Surgical Product (Genzyme Biosurgery)1999-03-30
TITANIUM VERSALOK (K990708)Wrightmedicaltechnologyinc1999-03-30
LAGLOVE BRAND NITRILE EXAMINATION GLOVE (POWDER FREE) (K990420)La Glove (M) Sdn. Bhd.1999-03-29
POWDER FREE BLUE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVES (K990299)Shanghai Palomar Mountain Industries, Inc.1999-03-29
CRANBERRY POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESSS) (K984039)Cranberry (M) Sdn. Bhd.1999-03-29
TUTOPLUS IV ADMINISTRATION SET (K990388)Myco Medical Supplies, Inc.1999-03-29
POWDERED BLUE NITRILE MEDICAL EXAMINATION GLOVES (K990267)Shanghai Palomar Mountain Industries, Inc.1999-03-29
RESOLUTION 45 (SPHERICAL) AND ULTRA GEL (TORIC) (HIOXIFILCON B) SOFT DAILY WEAR CONTACT LENS, )CLEAR & BLUE VISIBILITY T (K983496)Opti-Centre Laboratories1999-03-29
LAGLOVE BRAND NITRILE EXAMINATION GLOVES (LIGHTLY POWDERED) (K990415)La Glove (M) Sdn. Bhd.1999-03-29
BAUSCH & LOMB RENU EFFERVESCENT ENZYMATIC CONTACT LENS CLEANER (K983225)Bausch & Lomb, Inc.1999-03-29
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABP (K990210)Mexpo Intl., Inc.1999-03-29
DRAGER SOLA SERIES, MODELS 1000/700/500/300 (K984611)Drager Medizintechnik GmbH1999-03-29
FLEXISCOPE OPTOMODUL (K984641)Schoelly Fiberoptic GmbH1999-03-29
ADVANCED NIBP MODULE (K982641)Johnson & Johnson Medical, Inc.1999-03-29
ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/ (K990786)Princeton BioMeditech Corp.1999-03-26
DIGISCOPE OPHTHALMIC CAMERA (K990205)Eye Tel Imaging, Inc.1999-03-26
GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS (K982414)Gambro Healthcare1999-03-26
GLIADIN IGG ELISA TEST SYSTEM (K990204)Zeus Scientific, Inc.1999-03-26
MICRINS MICRO ANASTOMOSIS CLAMP (K982278)Micrins Surgical, Inc.1999-03-26
DORNIER MEDILAS H/2 (K984591)Dornier Surgical Products, Inc.1999-03-26
URETERO-RENOSCOPE, MODEL 8706.402, INSERTION SHEATH, MODEL 8706.042 (K990050)Richard Wolf Medical Instruments Corp.1999-03-26
TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19) (K990685)Ab Biodisk1999-03-26
C1 ULTRASOUND SYSTEM (K990806)Sonosite,Inc.1999-03-26
TRIFIX PEDICLE SPINAL SCREW ASSEMBLY (K990657)Corin USA1999-03-26
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPS (K990687)Olympus Optical, Co.1999-03-26
DUODERM HYDROACTIVE GEL WOUND DRESSING (K990368)Convatec, A Bristol-Myers Squibb Co.1999-03-26
ESOPHAGEAL INTUBATION DETECTOR (K990556)Wolfe Tory Medical, Inc.1999-03-26
GLIADIN IGA ELISA TEST SYSTEM (K990207)Zeus Scientific, Inc.1999-03-26
ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING. (K990639)Guidant Corp.1999-03-25
KEELER PULSAIR 3000 NON CONTACT TONOMETER (K990257)Keeler Instruments, Inc.1999-03-25
IMMUNOGLOBULIN A TEST SYSTEM (K990552)Dade Behring, Inc.1999-03-25
WILSON-COOK BIPOLAR PROBE (K990145)Wilson-Cook Medical, Inc.1999-03-25
OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM (K982798)Osteonics Corp.1999-03-25
PEREGRINE WET SET, MODEL PD400.00 (K990518)Peregrine Surgical , Ltd.1999-03-25
ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP (K990456)Hollister, Inc.1999-03-25
BCI MINI-TORR PLUS, MODEL 6004 (K984618)Bci Intl., Inc.1999-03-25
NORMED BONE TRANSPORT (K990140)Ace Surgical Supply Co., Inc.1999-03-25
VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RANGE VERIFIERS (K990783)Ortho-Clinical Diagnostics, Inc.1999-03-25
IGG FLEX REAGENT CARTRIDGE (K990551)Dade Behring, Inc.1999-03-25
BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND BALLOON DILATION CATHETERS, BALLOON DILATION C (K990072)Cook Urological, Inc.1999-03-25
JELDENT MULTICRYL (K990056)J.F. Jelenko & Co., Inc.1999-03-25
DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING (K990438)Dermaphylyx, Inc.1999-03-25
PERSONAL INFUSOR WITH DRUG DISPOSAL SEPTAL PORT (K990208)Science Incorporated1999-03-25
IBC FLOPUMP, MODEL 6000 (K983272)International Biophysics Corp.1999-03-24
JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200 (K982136)Schiff & Co.1999-03-24
PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.) (K990682)Nsk Nakanishi, Inc.1999-03-24
SEAL-AWAY HEMOSTASIS ADAPTER, MODEL 406229 (K984062)Diag Corp.1999-03-24
VASCULAR OCCLUSION SYSTEM (K983483)Cordis Neurovascular, Inc.1999-03-24
SOUTHLAND POWDERFREE (POLYMER-COATED) LATEX EXAMINATION GLOVES (K990751)Southland Products Co., Ltd.1999-03-23
OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM (K983229)Olympic Medical Corp.1999-03-23
HERMES OPERATING ROOM CONTROL CENTER (K990691)Computer Motion, Inc.1999-03-23
ACTIWATCH (K983533)Mini-Mitter Co., Inc.1999-03-23
THE.R.MO.FREE (K990448)Dentamax, Inc.1999-03-23
APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM (K984138)Zeus Scientific, Inc.1999-03-23
DIRECTFLOW ARTERIAL CANNULA (K990772)Heartport, Inc.1999-03-23
DEPUY ACE SPIDER PLATE (K990392)Depuy Ace Medical Co.1999-03-23
LACTOSORB BONE PIN (K990291)Biomet, Inc.1999-03-23
SOUTHLAND POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM (K990746)Southland Products Co., Ltd.1999-03-23
CONWAY STUART MEDICAL MODEL C4 ELECTROSURGICAL GENERATOR (K983986)Conway Stuart Medical, Inc.1999-03-23
ABLATOR ELECTRODE (K983652)Linvatec Corp.1999-03-23
RANDOX ALBUMIN (K984494)Randox Laboratories, Ltd.1999-03-23
SYNERGY D2 SPINAL IMPLANTS (K984578)Interpore Cross Intl.1999-03-23
STANDARD 0.025 STRAIGHT, STANDARD 0.025 ANGLED, STANDARD 0.032 STRAIGHT, STANDARD 0.032 ANGLED, SOFT 0.035 STRAIGHT, SOF (K983346)Guidant Corp.1999-03-23
ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY (K980737)Nichols Institute Diagnostics1999-03-23
EVERGREEN NON-STERILE POWDER-FREE, COLORED NITRILE EXAMINATION GLOVES (K990013)Yty Industry (Manjung) Sdn Bhd1999-03-23
DR180-R/OXY (K983576)North East Monitoring, Inc.1999-03-23
CHEMO MINI SPIKE PLUS (K983794)B. Braun of America, Inc.1999-03-23
NUVOLASE 532 LASER SYSTEM (K990725)American Laser Corp.1999-03-22
ARCHITECT PROGESTERONE MASTERCHECK MODEL #6C26-05 (K990393)Bio-Rad1999-03-22
MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS (K990707)Medtronics Interventional Vascular1999-03-22
NEUROTUBE (K983007)Neuroregen, LLC1999-03-22
ALOKA SSD-900 DIAGNOSTIC ULTRASOUND SYSTEM (K983879)Aloka Co., Ltd.1999-03-22
IGM FLEX REAGENT CARTRIDGE (K990553)Dade Behring, Inc.1999-03-22
DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE (K990090)Aesculap, Inc.1999-03-22
TISPORT X AND TISPORT XC (K990555)Tisport1999-03-22
DIMENSION SPECIAL PROTEIN CALIBRATOR (K990554)Dade Behring, Inc.1999-03-22
THE STELLAR TILT, MANUALLY OPERATED WHEELCHAIR (K990557)Pdg Product Design Group, Inc.1999-03-22
KSEA ENDOSCOPE HOLDER (K990334)KARL STORZ Endoscopy-America, Inc.1999-03-22
ISOBAR SPINAL SYSTEM (K990118)Scien'Tx USA, Inc.1999-03-22
ETEST MINOCYCLINE (K990297)Ab Biodisk1999-03-22
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) (K990460)Roche Diagnostics Corp.1999-03-22
NUVOLASE 532 CUTANEOUS LASER SYSTEM (K990780)American Laser Medical1999-03-22
AIR TECHNIQUES' DENTO-VAC (K984584)Air Techniques, Inc.1999-03-22
OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031 (K990249)Phamatech1999-03-22
MOSS GASTROSTOMY TUBE (K990389)Moss Tubes, Inc.1999-03-22
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