Atlas FDA

1998

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

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RecordFirmDate
SHARPTRACK REUSABLE SHARPS CONTAINER (K981184)Bfi- Medical Waste Systems1998-06-22
HOWMEDICA SCN NAIL (K981261)Howmedica Corp.1998-06-22
DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW AND DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW (K981670)Depuy, Inc.1998-06-22
OSTEO I-C HUMERAL NAIL SYSTEM (K981309)Osteonics Corp.1998-06-22
NITRILON CORRECT-TOUCH (K981333)Biopro (M) Sdn Bhd1998-06-22
OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER/ALCON WETTING, SOAKING, CONDITIONING AND DISINFECTING SOLUTION ID 84392 (K981151)Alcon Laboratories1998-06-22
SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEET (K981075)Synthes (Usa)1998-06-22
NITRILON CORRECT-TOUCH (K981304)Ct Intl.1998-06-22
MRS-400, MAXI 400, MRSL-400, MAXI 400L (K981990)D.B.I. America Corp.1998-06-22
AMM (K981467)Abbott Laboratories1998-06-22
INNOVASIVE DEVICES MENISCAL DART REPAIR SYSTEM (K981340)Innovasive Devices, Inc.1998-06-22
ACCUCORE CORE BIOPSY NEEDLE CATALOG CODES:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214 (K981166)Inrad1998-06-22
HYDROTONE (K974321)North American Technical Services Corp.1998-06-22
X-CELL WOUND DRESSING (K974251)Xylos Corporation1998-06-22
PHOTONIC STIMULATOR (K974468)Bales Scientific, Inc.1998-06-22
ALKP (K981806)Abbott Laboratories1998-06-22
URIC ACID (K981766)Abbott Laboratories1998-06-19
ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS (K981621)Suretex Prophylactics (India) , Ltd.1998-06-19
KONICA DIRECT DIGITIZER REGIUS MODEL 330 (K980873)Konica Corp.1998-06-19
FUKUDA DENSHI DYNASCOPE MODEL DS-5000 SERIES TELEMETRY SYSTEM (K980728)Fukuda Denshi USA, Inc.1998-06-19
QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT (K981330)Inova Diagnostics, Inc.1998-06-19
OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER (K973013)Vas-Cath, Inc.1998-06-19
SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS (K981286)Armm, Inc.1998-06-19
WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE (K981470)Worldwide Medical Technologies, LLC1998-06-19
QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT (K981328)Inova Diagnostics, Inc.1998-06-19
KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW (K981053)Eastman Kodak Company1998-06-18
DURACON(R) SMALL STABILIZER TIBIAL INSERT (K974843)Howmedica Corp.1998-06-18
STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT (K981167)Dhd Healthcare Corp.1998-06-18
MEDRAD NEUROVASCULAR COIL (K981094)Medrad, Inc.1998-06-18
PLATINUM READING, REVIEW & ANALYSIS WORKSTATION (K981217)GE Medical Systems1998-06-18
NFC NEEDLEFREE Y-SITE, MODEL 69970 (K981547)Filtertek, Inc.1998-06-18
KOALA VASCULAR CLAMPS AND INSERTS (K980002)Boss Instruments, Ltd.1998-06-18
NFC NEEDLEFREE CONNECTOR MODEL 69900 (K981548)Filtertek, Inc.1998-06-18
PHILIPS THORAVISION (K981657)Philips Medical Systems North America, Inc.1998-06-18
VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE (K981013)Becton Dickinson Vacutainer Systems1998-06-17
THE NETWORK SYSTEM (K980234)Medical Sni , Ltd.1998-06-17
SCOOP 1 (K981080)Transtracheal Systems1998-06-17
EASY RIDER MICRO CATHETER (K974473)Micro Therapeutics, Inc.1998-06-17
BLACKSTONE MEDICAL INC. ANTERIOR CERVICAL PLATE SYSTEM (K974885)Blackstone Medical, Inc.1998-06-17
BABYLOG 8000 PLUS (K974176)Drager, Inc.1998-06-17
MEDITEC LINK (K981196)Aesculap-Meditec North America1998-06-17
COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO (K973864)Pausch Corp.1998-06-17
CA (K981578)Abbott Laboratories1998-06-16
GC FUJI BOND LC (K981514)GC America, Inc.1998-06-16
ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES (K981003)International Medical Products, Inc.1998-06-16
ALLOYBOND (K981383)Southern Dental Industries, Inc.1998-06-16
AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000 (K981754)Porter Instrument Co., Inc.1998-06-16
BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH (K974761)John O. Butler Co.1998-06-16
HEARTVIEW P12/8 ELECTROCARDIOGRAPH RECORDER AND TRANSMITTER (K980144)Aerotel, Ltd.1998-06-16
PALI-TRODE (K981015)Preferred Instruments1998-06-16
MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING (EDM) VENTRICULAR CATHETER, 20CM AND 35 CM MODEL # 96115 AND 96118 (K981046)Medtronic PS Medical1998-06-16
INNOVASIVE 3.5MM METAL ROC XS SUTURE BONE FASTENER (K981193)Innovasive Devices, Inc.1998-06-16
KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6 (K980216)Kreativ, Inc.1998-06-16
ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST (K981197)Tcpi, Inc.1998-06-16
STABLE FLOW (K981157)Cmed1998-06-16
PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION (K980738)Byron Medical1998-06-16
PHOS (K981759)Abbott Laboratories1998-06-16
KERR HARD DENTURE RELINE MATERIAL (K981448)Sybron Dental Specialties, Inc.1998-06-16
WATER FILLED GUM SOOTHER (K981202)Corium Corp.1998-06-16
AIC - CHEK (HBAIC-I) (K973365)Express-Med, Inc.1998-06-15
CCA-200 (K981439)Benson Medical Instruments Co.1998-06-15
I-STAT COAGULATION CONTROL SET (K981752)Biopool Intl., Inc.1998-06-15
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT (K981632)Roche Diagnostics/Boehringer Mannheim GmbH1998-06-15
ETEST BENZYLPENICILLIN (K980335)Ab Biodisk1998-06-15
MODEL M1792A THROMBOLYTIC PREDICTIVE INSTRUMENT (K974087)Hewlett-Packard Co.1998-06-15
COLOR-SLIDE RF (K981496)Seradyn, Inc.1998-06-15
SERAQUEST ANTI-SM (K980540)Quest Intl., Inc.1998-06-15
SERAQUEST ANTI-SSB (K980639)Quest Intl., Inc.1998-06-15
KSEA CALCUSPLIT (K981233)KARL STORZ Endoscopy-America, Inc.1998-06-15
MOTILITY PROBE MODEL NUMBERS P31 THRU P38, P40 THRU P43 AND P50 (K980980)Konigsberg Instruments, Inc.1998-06-15
ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219 (K981864)Beckman Coulter, Inc.1998-06-12
FRACTURE RISK ASSESSMENT CAPABILITY FOR NORLAND X-RAY BONE DENSITOMETERS (K980569)Norland Corp.1998-06-12
CLEANING SOLUTION (1) MODEL NUMBER A943-795, SALT BRIDGE SOLUTION MODEL NUMBER A943-794, CALIBRATION SOLUTION, PH 7.4 MO (K981795)Thermo Bioanalysis Corp.1998-06-12
RIGID CULDOSCOPE AND ACCESSORIES (K980972)Circon Corp.1998-06-12
B-D PEN ULTRA (K981797)Bd Becton Dickinson Vacutainer Systems Preanalytic1998-06-12
NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM (K973096)Neotonus, Inc.1998-06-12
RESPIRTECHPRO (K973975)Vortran Medical Technology 1, Inc.1998-06-12
FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE (K980979)Fukuda Denshi USA, Inc.1998-06-12
FRACTURE RISK ASSESSMENT FOR THE NORLAND SXA 3000 BONE DENSITOMETER (K980289)Norland Corp.1998-06-12
56 SERIES AEROSOL GENERATOR (K980074)Project Marketing1998-06-12
PHOS (K981118)Abbott Laboratories1998-06-12
ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP (K981771)Princeton BioMeditech Corp.1998-06-12
COSGROVE CLAMP (K974769)Allegiance Healthcare Corp.1998-06-12
IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT (K981638)Beckman Coulter, Inc.1998-06-12
ALBG (K981758)Abbott Laboratories1998-06-12
VARIAN XIMATRON SCAN VISION CT (K981056)Varian Medical Systems, Inc.1998-06-12
BODYSTAT DUALSCAN 2005 (K980971)Bodystat , Ltd.1998-06-11
QTEXX POWDERFREE LATEX EXAMINATION GLOVES (K981767)Latexx Partners Bhd.1998-06-11
JIN ACUPUNCTURE NEEDLES, MODELS ST, GL, SI, PT, AND ID (K980899)Kenshin Trading Corp.1998-06-11
DRYALYSATE CONCENTRATE (K980659)Advanced Renal Technologies, Inc.1998-06-11
HDL (K981580)Abbott Laboratories1998-06-11
3M M.G. MATERIAL (K981325)3M Company1998-06-11
ODONTOSURGE 2 (K981390)Periogiene1998-06-11
BECTON DICKINSON SYRINGE (K980987)Bd Becton Dickinson Vacutainer Systems Preanalytic1998-06-11
KILOWIN (K971214)Cadwell Laboratories, Inc.1998-06-11
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4000 (K964153)Rossmax International , Ltd.1998-06-11
MEDICAL BIOPSY AUTOMATIC CUTTING NEEDLE (K981477)Medical Biopsy, Inc.1998-06-10
ACE T UPTAKE REAGENT TU CALIBRATORS (K981375)Schiapparelli Biosystems, Inc.1998-06-10
TC SERIES (TRANSPORT) (K981418)Get A Life-Give A Living Plus Kids Project, Inc.1998-06-10
ACE T4 REAGENT T4 CALIBRATORS (K981377)Schiapparelli Biosystems, Inc.1998-06-10
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