Atlas FDA

1998

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

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RecordFirmDate
SURGEON'S GLOVES (K974356)American Health Products, Inc.1998-01-29
POWDERED NITRILE EXAMINATION GLOVES (K980149)Masju Sdn. Bhd.1998-01-29
POWDERFREE GREEN NITRILE EXAMINATION GLOVES (K974887)Sri Johani Sdn. Bhd.1998-01-29
HYDROGUM (K974704)Zhermack S.P.A.1998-01-29
VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE (K974130)Dejarnette Research Systems1998-01-29
ZEROWET SPLASHIELD (K974288)Zerowet, Inc.1998-01-29
EASYSAFE RETRACTING NEEDLE SYRINGE (K973792)Saf-T-Med, Inc.1998-01-29
FOUNDATION POROUS COATED FLARED RIM SHELL (K974095)Encore Orthopedics, Inc.1998-01-28
BACTEC MYCO/F LYTIC CULTURE VIALS (K970333)Becton Dickinson Microbiology Systems1998-01-28
DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRODE (DLM) (K974119)Jack'S Electrodes1998-01-28
CARESIDE GLOBULIN (K980055)Exigent Diagnostics, Inc.1998-01-28
QUALICHECK5+ MODELS S7730, S7740, S7750, S7760 (K980135)Radiometer America, Inc.1998-01-28
HM-RUBY (K974142)American Lasers, Inc.1998-01-28
PUBOUURETHRAL SLING (K974098)ETHICON, Inc.1998-01-28
RIFAMPICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K971636)Oxoid , Ltd.1998-01-28
EMS NASAL CPAP MASK (K972605)Engineered Medical Systems1998-01-28
STC METHAMPHETAMINE MICRO-PLATE EIA (K972989)OraSure Technologies, Inc.1998-01-28
MIS ELECTROSURGICAL ELECTRODE (K971829)E-Tek, Inc.1998-01-28
STAT TRACKS (K974762)Awareness Technology, Inc.1998-01-28
FOUNDATION POROUS ACETABULAR SYSTEM (K973119)Encore Orthopedics, Inc.1998-01-28
LQUET CANNULA/TROCAR SYSTEM (K974139)Lifequest Endoscopic Technologies, Inc.1998-01-28
DIAMEDIX IS-MEASLES IGG TEST SYSTEM (K974552)Diamedix Corp.1998-01-28
NARKOMED ULTRASONIC FLOW SENSOR (K974193)Draeger Medical, Inc.1998-01-28
PARACENTESIS CATHETER DEVICE (K974146)Allegiance Healthcare Corp.1998-01-28
FOUNDATION POROUS COATED HEMISPHERICAL SHELL (K974093)Encore Orthopedics, Inc.1998-01-28
NON-PRESCRIPTION SUNGLASSES (K974861)Wenzhou Hindar Optical Co., Ltd.1998-01-27
COBE OXYGENATOR PRODUCTS (K974085)Cobe Cardiovascular, Inc.1998-01-27
N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000 (K973037)Avid N.I.T., Inc.1998-01-27
BREEZY SERIES (K974820)Sunrise Medical, Inc.1998-01-27
X-SIGHT DIGITAL IMAGING SYSTEM (K974134)Stallion Technologies, Inc.1998-01-27
PERCUPUMP II WITH EDA (K974621)E-Z-Em, Inc.1998-01-27
BIOSPECTROMETER-NB OXIMETER IIII (K963903)Hutchinson Technology, Inc.1998-01-27
ENDOLYMPHATIC SAC TO MASTOID T-SHUNT (K974224)Exmoor Plastics , Ltd.1998-01-27
RUSCH SIMPLASTIC COUNCILL TIP CATHETER (K974419)Rusch, Inc.1998-01-27
MEDRAD 1.5T PERIPHERAL VASCULAR ARRAY (K974308)Medrad, Inc.1998-01-27
ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606 (K965106)Biotronik, Inc.1998-01-27
VIROTROL III (K974613)Blackhawk Biosystems, Inc.1998-01-27
ACTIVATOR II (K973506)Activator Methods, Inc.1998-01-27
CD-R STATION AND VRS-2000 (K974255)Electromed Intl., Ltd.1998-01-27
RINOFLOW MICRONIZED E.N.T. WASH SYSTEM (K973875)Respironics, Inc.1998-01-26
PYRILINKS-D ASSAY KIT (K974260)Metra Biosystems, Inc.1998-01-26
BLUETEST(R) PREGNANCY TEST, RAPIDVUE(R) PREGNANCY TEST (K974821)Quidel Corp.1998-01-26
ROSS ENTERAL FEEDING TUBE (K972437)Ross Products1998-01-26
CORONARY VEIN GRAFT TAG MARKER (K971966)Med-Edge, Inc.1998-01-26
PERIO CONTROL II (K972642)Estrad B.V.1998-01-26
HUNTLEIGH FP5000 SYSTEM MODEL FP5000 (K965153)Huntleigh Healthcare, Inc.1998-01-26
QUICKSTICK PRO HCG TEST (K974615)Phamatech1998-01-26
ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM (K974451)Lifescan, Inc.1998-01-26
BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL (K974733)Boehringer Mannheim Corp.1998-01-26
22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CAR (K973713)Cardiovascular Dynamics, Inc.1998-01-23
HYDROBRUSH (TM) KERATOME (K971078)Medjet, Inc.1998-01-23
INTELECT (K974497)Chattanooga Group, Inc.1998-01-23
COOPERSURGICAL INFRARED COAGULATOR (K974168)Hogan & Hartson1998-01-23
MCKINLEY OUTBOUND-2 SYSTEM (K971844)Mckinley, Inc.1998-01-23
RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT (K972025)Radius Intl., Inc.1998-01-23
ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1) (K965209)Arrow Intl., Inc.1998-01-23
WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY NEEDLE (K974794)Worldwide Medical Technologies, LLC1998-01-23
MICROCON 800M, MICROCON 400M, MICROCON EXC, MICROCON EX, MICROCON WALLMAP (K974682)Biological Controls, Inc.1998-01-23
WOUND DRAINAGE HOLDER (K973183)R & D Medical Products, Inc.1998-01-23
EXMOOR TYMPANOCENTESIS KIT (TK/1) (K973587)Exmoor Plastics , Ltd.1998-01-23
ADVANCED TREATMENT PLANNING SYSTEM (K972816)Advanced Radiation Therapy Systems, Inc.1998-01-23
MEGAPULSE II (K973732)Pti1998-01-23
WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET (K974118)Worldwide Medical Technologies, LLC1998-01-23
RADIUS PUSH OVER THE GUIDE WIRE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT (K972102)Radius Intl., Inc.1998-01-23
PROCERA PREPARABLE ABUTMENT SYSTEM (K974150)Nobel Biocare Uas, Inc.1998-01-23
ORATEC MODEL ENDOTAC PROBE (K972358)Oratec Interventions, Inc.1998-01-23
WORLDWIDE MEDICAL TECHNOLOGIES I TYPE NEEDLE (K980068)Worldwide Medical Technologies, LLC1998-01-23
SMITH & NEPHEW DYONICS ARTHOSCOPES/ENDOSCOPES, SMITH & NEPHEW DYONICS LAPAROSCOPES, SNITH & NEPHEW DYONICS HYSTEROSCOPES (K974767)Endoscopy Division1998-01-23
ULTIMATE COMPRESSION SCREW SYSTEM (K972722)Orthopedic Designs, Inc.1998-01-23
FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER (K970866)Georgia Biomedical, Inc.1998-01-23
ELCOMED 100 TYPES 9925 (W&H- AND INNOVA-VERSION) AND 9927 (ASTRA-VERSION), ELCOMED 200 TYPE 9926 (W&H-VERSION) (K972889)W & H Dentalwerk1998-01-22
PHILIPS EASYVISION WORKSTATION (K974207)Philips Medical Systems North America, Inc.1998-01-22
SAN DIEGO BIOTECH HCG PREGNANCY URINE TEST (K974851)San Diego Biotech1998-01-22
COREGISTRATION FUNCTION (K972451)Nomos Corp.1998-01-22
BECTON DICKINSON TWINPAK (K974006)Bd Becton Dickinson Vacutainer Systems Preanalytic1998-01-22
AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROL (K974822)Avl Scientific Corp.1998-01-22
KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES (K972488)Karl Storz Endoscopy1998-01-22
MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER 1000 METER, MTM BIOSCANNER G TEST STRIP, NORMAN GLUCOSE CON (K972669)Polymer Technology Systems, Inc.1998-01-22
ZAK-2000 (K972022)Cardio Systems, Inc.1998-01-22
ACUPUNCTURE NEEDLE UNDER THE BRAND NAME HWATO AND HUAXIA (K974122)Scientific Health Care1998-01-22
RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS (K974066)Microline Pentax, Inc.1998-01-22
BM PRECIPATH(R) HDL/LDL-C CONTROL (K974826)Boehringer Mannheim Corp.1998-01-22
MIGHTY AIR (K974319)Wheelchairs of Kansas1998-01-22
IBU, INTEGRATED BRACHY THERAPY UNIT (K973848)Nucletron Corp.1998-01-22
GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90 (K972576)Accumed Intl., Inc.1998-01-22
FORMULA FOR ARCHIMED (K974079)Biosound Esaote, Inc.1998-01-22
INTERPLEURAL ANESTHESIA CATHETER (K971851)Axiom Medical, Inc.1998-01-22
MILLS INCUS HA SLEEVE (K974365)Exmoor Plastics , Ltd.1998-01-22
REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE (K974699)Consolidated Technologies, Inc.1998-01-22
RADIUS LOW PROFILE GASTROSTOMY TUBE KIT (K971901)Radius Intl., Inc.1998-01-22
GENERAL PURPOSE ATL NEEDLE GUIDE KIT (K973958)Protek Medical Products, Inc.1998-01-22
LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30 (K974859)Diagnostic Chemicals , Ltd.1998-01-22
GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEAD (K974044)DePuy Orthopaedics, Inc.1998-01-22
SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE (K974076)Bio-Logic Systems Corp.1998-01-22
BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO TREATMENT (K974155)Baxter Healthcare Corp1998-01-22
PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-A (K974471)Sims Deltec, Inc.1998-01-22
NURSE'S AID PATIENT ROTATION SYSTEM (K973624)Air Med Assist Products1998-01-21
CARPAL ENGAGING WRIST FUSION PLATE (K974030)Terray Corp.1998-01-21
KODAK DIGITAL SCIENCE QUALITY CONTROL WORKSTATION (QCW) (K974107)Eastman Kodak Company1998-01-21
MICROVASIVE LIPTHOTRIPSY PROBES (K973788)Boston Scientific Corp1998-01-21
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