Atlas FDA

1998

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

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RecordFirmDate
MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM (K982154)Danek Medical, Inc.1998-07-13
VPC-94 ULTRA HIGH ENERGY COLLIMATERS MODEL NUMBERS 480-685-9402 (K981352)Ge Medical Systems F.I. Haifa1998-07-13
LYSONIX SUCTION LIPOPLASTY SYSTEM (K980771)Lysonix, Inc.1998-07-13
NEUROMETRIC ANALYSIS SYSTEM (K974748)Nxlink, Ltd.1998-07-10
PERMACEM AUTOMIX LUTING CEMENT SYSTEM (K981813)Foremost Dental Mfg., Inc.1998-07-10
LAKE REGION MANUFACTURING GUIDEWIRES (K981326)Lake Region Mfg., Inc.1998-07-10
ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) (K981698)Chiron Corp.1998-07-10
RADIOCAMERAS BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM (K981346)Surgical Navigation Technologies, Inc.1998-07-10
DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA (K974763)Deroyal Industries, Inc.1998-07-10
MICROCOOL SURGICAL GOWN (K981393)Kimberly-Clark Corp.1998-07-10
PRILANE (K981524)Gresco Products, Inc.1998-07-10
BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER (K974652)Baxter Healthcare Corp1998-07-10
OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE (K981464)Omnitech Systems, Inc.1998-07-10
CPAP HUMIDIFIER (HC 200) (K973161)Fisher & Paykel Electronics , Ltd.1998-07-10
CONVERTORS TRILAMINATE DRAPES (K981818)Allegiance Healthcare Corp.1998-07-10
KIMBERLY-CLARK GAS PLASMA STERILIZATION INDICATOR STRIP (K974415)Kimberly-Clark Corp.1998-07-10
BROWNE TST SINGLE USE BOWIE-DICK TYPE TEST PACK (K971971)Board of Directors, Albert Browne , Ltd.1998-07-10
FLOWABLE COMPOSITE (K981965)Dentsply Intl.1998-07-10
TEMPO III (K981509)Medical Products, Inc.1998-07-10
HEART CATH TRAY, STERILE, DISPOSABLE (K981441)Trinity Laboratories, Inc.1998-07-10
VIGIL PROTEIN CONTROL (K982224)Beckman Coulter, Inc.1998-07-09
SILIMED MALAR IMPLANT (K981835)Silimed, LLC1998-07-09
NAVITRACK (K981315)Orthosoft, Inc.1998-07-09
MYCYCLE, HANDMASTER, VICTORY (K981557)Richvale , Ltd.1998-07-09
TRX-CG CENTER-OF-GRAVITY SHIFTING POWER TILT AND RECLINE SYSTEMS (K981837)Motion Concepts1998-07-09
OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES, OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS (K982032)Osteonics Corp.1998-07-09
MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA (K982210)Dade Behring, Inc.1998-07-09
ALEXIS ALEXANDRITE LASER SYSTEM AND ACCESSORIES (K981350)Xintec Corporation1998-07-09
SURGIN KIT (K980849)Surgin Surgical Instrumentation, Inc.1998-07-09
SEQUENCER (K981313)Impac Medical Systems, Inc.1998-07-09
TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW (K981529)Smith & Nephew, Inc.1998-07-09
DEGANIA SILICONE IDENTI LOOPS (K981956)Degania Silicone , Ltd.1998-07-09
ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG (K981579)ETHICON, Inc.1998-07-09
TITANIUM PEG SYSTEM (K980822)Fci Ophthalmics, Inc.1998-07-09
TAKA ANEURYSM CLIP (K972750)V. Mueller Neuro/Spine1998-07-09
AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2 (K981706)Abbott Laboratories1998-07-09
SILIMED SILICONE CARVING BLOCK (K981851)Silimed, LLC1998-07-09
MYCYCLE HANDMASTER, LIGHT (K981558)Richvale , Ltd.1998-07-09
MAGNATEK C-300 (K981310)Magna Advanced Technologies, Inc.1998-07-09
MENTOR PATHWAY INTRODUCER/DILATOR (K981527)Mentor Corp.1998-07-09
MONARCH IOL DELIVERY SYSTEM (K981571)Alcon Laboratories1998-07-09
SINGLE CHANNEL BALLOON CANNULA (K974801)Conkin Surgical Instruments , Ltd.1998-07-09
SILIMED CHIN IMPLANTS (K981850)Silimed, LLC1998-07-09
LASER LANCET LB100 (K980538)Transmedica Intl., Inc.1998-07-09
CERMAX300 LIGHTSOURCE (K981469)Cuda Products Co.1998-07-09
PREPTECH(TM) 200 CAVITY PREPARATION SYSTEM (K974655)Prep Technology Corp.1998-07-09
MITYVAC (K980212)Prism Technologies, Inc.1998-07-09
SPEED-CUT AUTOMATIC BIOPSY SYSTEM (K981301)Gallini U.S., LLC1998-07-08
SIEMENS SC9000/SC9015 ENHANCED WITH 12-LEAD ST SEGMENT ANALYSIS (K974698)Siemens Medical Solutions USA, Inc.1998-07-08
ODYSSEY INSTRUMENTATION SYSTEM (K981294)Automata Instrumentation, Inc.1998-07-08
SKINTONER SYSTEM (K980501)Fuller Research Corp.1998-07-08
KSEA UROPUMP (K981615)KARL STORZ Endoscopy-America, Inc.1998-07-08
EBI DFS JOINT FIXATOR, MODEL 02800 (K981483)Electro-Biology, Inc.1998-07-08
ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER (K981612)Rochester Medical Corp.1998-07-08
SUGITRON MODEL: IEC (K980177)Ellman Intl., Inc.1998-07-07
ACS:CENTAUR AFP (K981592)Chiron Diagnostics Corp.1998-07-07
IL TEST PT-FIBRINOGEN RECOMBINANT (K981479)Instrumentation Laboratory CO1998-07-07
GALILEO DISPOSABLE HYSTEROSCOPES (K981828)Netoptix Corp.1998-07-07
PERCUTANEOUS BREAST BIOPSY (PBB) (K972328)Urothealth System, Inc.1998-07-07
CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER (K972899)Cypress Medical Products, Ltd.1998-07-07
UNICAP THYROID PEROXIDASE IGG (K981930)Pharmacia & Upjohn Co.1998-07-07
PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM (K972255)Pulse Biomedical, Inc.1998-07-07
UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY (K981559)Pharmacia & Upjohn Co.1998-07-07
ANU ICE (K981428)Cryoptherapy Pain Relief Products, Inc.1998-07-07
HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE (K974799)International Technidyne Corp.1998-07-07
GLOVE, OAKTEX EXAMINATION, GLOVE, PATIENT EXAMINATION (K981488)Oak Carolina, Inc.1998-07-07
CUTALON NYLON POLYAMIDE SURGICAL SUTURE (K981322)Genzyme Surgical Product (Genzyme Biosurgery)1998-07-07
CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM (K980487)Baxter Edwards1998-07-07
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844 (K981883)Boehringer Mannheim Corp.1998-07-07
BIPOLAR FORCEPS SET (MODULAR) (K981321)Richard Wolf Medical Instruments Corp.1998-07-07
SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.606 (K981800)Equal Diagnostics, Inc.1998-07-06
COMPLETE BRAND MULTI-PURPOSE SOLUTION (K980775)Allergan, Inc.1998-07-06
INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL PULMONARY RESUSCITATOR WITH RUBBER COMPRESSION BAG (K981308)International Respiratory Systems, Inc.1998-07-06
SEVRAIN CRANIAL CLAMP (K971252)Ikonos Corp.1998-07-06
ADVANTAGE 3D XR (K974715)GE Medical Systems1998-07-06
DRAGER-VAPOR 19.3 (K981773)Draeger Medical, Inc.1998-07-06
VIGIL HEMOGLOBIN (HBALC) CONTROLS (K982022)Beckman Coulter, Inc.1998-07-06
IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS (K974837)Igel Vision Care Pte , Ltd.1998-07-06
CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM (K981262)Valleylab, Inc.1998-07-06
OPTI-FREE EXPRESS MULTI-PURPOSE SOLUTION (K981574)Alcon1998-07-06
ETEST CEFDINIR (K980877)Ab Biodisk1998-07-06
ANSPACH SHIELDED ATTACHMENT (K974025)The Anspach Effort, Inc.1998-07-06
ADI SYPHILIS RPR LIQUID CONTROLS (K980638)Ampcor Diagnostics, Inc.1998-07-06
INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR (K981307)International Respiratory Systems, Inc.1998-07-06
CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST (K981882)Princeton BioMeditech Corp.1998-07-06
KYPHON INFLATABLE BONE TAMP (K981251)Kyphon, Inc.1998-07-02
BABY PACIFIER DIGITAL THERMOMETER (K981456)K-Jump Health Co., Ltd.1998-07-02
SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER (K974868)Perry Baromedical Corp.1998-07-02
ARISTON PHC LINER (K981335)Ivoclar North America, Inc.1998-07-02
NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633 (K973363)Ml Strategies, Inc.1998-07-02
ARISTON PHC (K981264)Ivoclar USA, Inc.1998-07-02
POREX NOSTRIL RETAINERS (K981374)Porex Surgical, Inc.1998-07-02
AC/AD LINEARITY VERIFIERS (K982217)Sc Calibrators & Controls, LLC1998-07-02
OSTEOGRAF/N-300 (K981182)Ceramed Dental, LLC1998-07-02
HERNIA MESH STABILIZER (K981598)Medivices Co.1998-07-01
PSI-TEC LIPOSUCTION ASPIRATOR (K981215)Byron Medical1998-07-01
UNIVERSAL INSTRUMENT REGISTRATION (UIR) MICROSCOPE MODULE I (K981213)Radionics, Inc.1998-07-01
HAKIM PROGRAMMABLE VALVE SYSTEM (K974739)Johnson & Johnson Professionals, Inc.1998-07-01
ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001 (K981187)Arthrex, Inc.1998-07-01
STAIR-LIFT (K981486)Garaventa (Canada) , Ltd.1998-07-01
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