Atlas FDA

1998

3,775 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ORATEC SPINECATH INTRADISCAL CATHETER (K974464)Oratec Interventions, Inc.1998-03-19
PUNCTURENEEDLE (K963794)Ferguson Medical1998-03-19
IL TEST HEPARIN (K980242)Instrumentation Laboratory CO1998-03-19
LD2000 SERIES (K980565)General Scanning, Inc.1998-03-19
PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS (K974202)Pulpdent Corp.1998-03-19
SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE (K980313)Schwartz Electro-Optics, Inc.1998-03-19
STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR (K973532)Dhd Diemolding Healthcare Div.1998-03-19
TYROSINE 50-HOUR REAGENT KIT (K970093)Astoria-Pacific, Inc.1998-03-19
DISPOSABLE ESOPHAGEAL STETHOSCOPE (K973839)Catheter Research, Inc.1998-03-19
DERMIUM (K980561)Premier Laser Systems, Inc.1998-03-19
ASTRA TECH IMPLANTS - DENTAL SYSTEM (K980698)Astra Tech, Inc.1998-03-19
IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE (K980523)Diametrics Medical, Inc.1998-03-19
JENASCAN (K980001)Jenoptik Laser, Optik, Systeme GmbH1998-03-19
TUMORLOCALIZER MRI (K962615)Ferguson Medical1998-03-19
FONIX FP35 HEARING AID ANALYZER (K980377)Frye Electronics, Inc.1998-03-18
M1765A ECG MANAGER (K974746)Hewlett-Packard Co.1998-03-18
UFR FIBEROPTIC CABLE (K972225)Universal Fiberoptic Repair, Inc.1998-03-18
NIDEK MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-7000 (K974732)Nidek, Inc.1998-03-18
BIOZ.COM SYSTEM (K974725)Cardiodynamics International Corp.1998-03-18
SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER (K974726)Elekta Implants, SA1998-03-18
ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER (K974544)Aloka Co., Ltd.1998-03-18
DEPUY TRI-LOCK HIP STEM (K974740)Depuy, Inc.1998-03-18
ENDOPATH AND PROXIMATE LINEAR CUTTERS (K980023)Ethicon Endo-Surgery, Inc.1998-03-18
ELECSYS CA 125 II (K972162)Boehringer Mannheim Corp.1998-03-18
SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATES (K974908)Synthes (Usa)1998-03-18
ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505 (K980173)Beckman Instruments, Inc.1998-03-18
AUTO-DRIVE BONE SCREW (K974785)Osteomed Corp.1998-03-18
ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING (K974186)Orthofix Srl1998-03-18
SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEM (K973687)Spinal Concepts, Inc.1998-03-18
LYSONIX ASPIRATION PUMP (K980454)Lysonix, Inc.1998-03-18
INCL II ENDOSCOPE (K963642)Sofamor Danek USA,Inc.1998-03-18
NETCO MEDICAL DATA TRANSPORTATION SERVICE SOFTWARE (K980241)Netco Communications Corp.1998-03-17
SHIELD HELICO-G2 ELISA KIT (K972981)Shield Diagnostics, Ltd.1998-03-17
GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM (K980247)Gynex Corp.1998-03-17
CTS MIDCAB STITCHER (K963965)Cardiothoracic Systems, Inc.1998-03-17
DCAT EMBOLECTOMY CATHETER SYSTEM (K971314)AngioDynamics, Inc.1998-03-17
IMIX DIGITAL THORAX SYSTEM (K974863)Advanced Instrument Development, Inc.1998-03-17
DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS (K973129)Denver Biomaterials, Inc.1998-03-17
DI-2000 (K980213)Lumisys, Inc.1998-03-17
KODAK DIGITAL SCIENCE ONCOLOGY IMAGE MANAGER (K980118)Eastman Kodak Company1998-03-17
ABBOTT GEMSTAR IV INFUSION PUMP (K974778)Abbott Laboratories1998-03-17
IMMUSTRIP HAMA IGG (K972873)Immunomedics, Inc.1998-03-17
4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG (K973364)Maersk Medical A/S1998-03-17
IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S (K980331)More Diagnostics1998-03-16
NITRILE EXAM GLOVE, POWDER FREE (K980677)Ningbo Yujiang Plastic & Rubber Co. , Ltd.1998-03-16
RADIONICS DISPOSABLE RF CANNULAE (SC-C, RFK-DB, RFK-DS) (K980430)Radionics, Inc.1998-03-16
CRYSTAL AND CRYSTAL-SEAL IMPLANTS SYSTEM (K980442)Crystal Medical Technology1998-03-16
DIO-LIGHT LASER SYSTEM (K980201)Nidek, Inc.1998-03-16
ZOLL REVIVER (K972241)Zoll Medical Corp1998-03-16
CSR (K974865)Parkell, Inc.1998-03-16
MULTI-LINK CABLE AND LEAD WIRE SYSTEMS (K980582)Marquette Medical Systems, Inc.1998-03-16
AMPLAID MK12 (K971740)Amplifon S.P.A.1998-03-16
SYNTHES CRANIAL SPRING CLIP (CSC) (K974206)Synthes (Usa)1998-03-16
ORION ANTERIOR CERVICAL PLATE SYSTEM (K973854)Sofamor Danek USA,Inc.1998-03-16
REPLACE CYLINDRICAL IMPLANTS (K980439)Steri-Oss, Inc.1998-03-16
OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM (K974807)Osteonics Corp.1998-03-16
ACUMED SUTURE ANCHOR (K980103)Acu Med, Inc.1998-03-16
OSMO/PCA PILLOW WOUND DRESSING (K971612)Procyte Corp.1998-03-16
EXTERNAL FIXATOR (K974911)Avanta Orthopaedics, Inc.1998-03-16
SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR AND POSTERIOR SPINAL SYSTEMS (K974749)Cross Medical Products, Inc.1998-03-13
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN) (K980572)Hartalega Sdn Bhd1998-03-13
INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS) (K971591)David C. Bishop, Ph.D.1998-03-13
HI-TORQUE FLOPPY GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE STANDARD GUIDE WIRE WITH HYDROCOAT HYDROPHILIC (K974773)Guidant Corp.1998-03-13
LATEX EXAMINATION GLOVE POWDER FREE (K974870)Smart Glove Corp. Sdn Bhd1998-03-13
ATHENA 1:1 CONTRA ANGLE, ATHENA 4:1 CONTRA ANGLE, ATHENA 16:1 CONTRA ANGLE, ATHENA 64:1 CONTRA ANGLE, ATHENA 16-: CONTRE (K974670)Athena Technology, Inc.1998-03-13
COAXIAL DILATOR SET (K974640)Boston Scientific Corp1998-03-13
POWDERFREE BLUE NITRILE EXAMINATION GLOVES (K980285)Besglove Medicare Sdn. Bhd.1998-03-13
NITRILE PRE-POWDERED EXAMINATION GLOVES (K974907)Smart Glove Corp. Sdn Bhd1998-03-13
NITRILE EXAMINATION GLOVES - POWDER FREE (K980511)Influx Pacific Sdn. Bhd.1998-03-13
LOVYTEX SDN BHD POWDER-FREE LATEX EXAMINATION GLOVES (K980618)Lovytex Sdn Bhd1998-03-13
LATEX EXAM GLOVE, POWDER-FREE W/PROTEIN & HYPOALLERGENIC LABELING (K973664)Evergrade Healthcare Products Sdn Bhd1998-03-13
SUPERGLOVES LOW PROTEIN POWDER FREE LATEX EXAMINATION GLOVES (K980071)Supermax Latex Products Sdn. Bhd.1998-03-13
OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE (K980419)Omnigrace (Thailand) , Ltd.1998-03-13
POWDERFREE LATEX EXAMINATION GLOVES (K980194)Besglove Medicare Sdn. Bhd.1998-03-13
DRG MF TITANIUN ALLOY BONE SCREW 1.0MM, 1.2MM, 1.3MM, 1.5MM, 1.7MM, 2.0MM, 2.4MM (K974817)Doctor'S Research Group, Inc.1998-03-13
LATEX EXAMINATION GLOVES (K980215)P.T. Wantong Industry1998-03-13
PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG (K974009)International Newtech Development, Inc.1998-03-13
VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA (K973628)Vital Scientific N.V.1998-03-13
ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA (K980249)Princeton BioMeditech Corp.1998-03-13
HOWMEDICA(R) FULLY THREADED SCREWS (K974720)Howmedica, Inc.1998-03-13
YEUNG ENDOSCOPIC SPINE SYSTEM (K973405)Richard Wolf Medical Instruments Corp.1998-03-13
COMBICATH CATHETER (K974642)Plastimed Laboratoire Pharmaceutique1998-03-13
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED (K980421)Omnigrace (Thailand) , Ltd.1998-03-13
MSI SURGICAL DRAPES (K974672)Medical Specialty Innovations, Inc. (Msi)1998-03-13
PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S) (K972749)C.M. Chance , Ltd.1998-03-13
AESCULAP ABC CERVICAL PLATING SYSTEM (K974706)Aesculap, Inc.1998-03-13
WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS (K973474)Witt Biomedical Corporation1998-03-13
POWDERFREE BLUE NITRILE EXAMINATION GLOVES (POLYMER COATED) (K980275)Besglove Medicare Sdn. Bhd.1998-03-13
CH-601A AND CH-601B DIGITAL WRIST SPHYGMOMANOMETER (CH-601A/CH-601B) (K973061)Citizen Watch Co., Ltd.1998-03-13
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH PERMALUME COVERING (K980163)Boston Scientific Scimed, Inc.1998-03-13
SMARTTEX (K974557)Smart Glove Corp. Sdn Bhd1998-03-13
MS-700 (K972213)Alan S. Lee1998-03-13
POWDERFREE LATEX EXAMINATION GLOVES (K980167)Besglove Medicare Sdn. Bhd.1998-03-13
POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR) (K980280)Besglove Medicare Sdn. Bhd.1998-03-13
SILICONE ELASTOMER SHEETING (K974653)Specialty Surgical Products, Inc.1998-03-13
M500-100 SHARPS CONTAINER (K980003)Imagination Medical, Inc.1998-03-13
GAS MODULE II, MODEL 0998-00-0143 (K974903)Datascope Corp.1998-03-13
BREATHING CIRCUIT BACTERIAL FILTER (K973797)King Systems Corp.1998-03-12
LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER (K974796)Medispec, Ltd.1998-03-12
BICOAG COAGULATING FORCEPS (K971565)Everest Medical Corp.1998-03-12
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