Atlas FDA

1997

4,309 FDA 510(k) clearances · Clearance year

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RecordFirmDate
KENDALL DUAL LUMEN CATHETER (K963446)Kendall Healthcare Products Co. Div.Of Tyco Health1997-03-18
MDA HEPARIN ANTI-X ASSAY (K965076)Organon Teknika Corp.1997-03-18
GENESIS RMP (K963268)Tecan U.S., Inc.1997-03-18
EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT (K970467)Excel Scientific, Inc.1997-03-18
VZV ANTIGEN CONTROL SLIDES (K964872)Viral Antigens, Inc.1997-03-18
LASER EYE GOGGLES (K970361)Stefanovsky & Assoc.1997-03-18
RSV ANTIGEN CONTROL SLIDES (K964870)Viral Antigens, Inc.1997-03-18
ILT ARGON HP (K964524)Ion Laser Technology1997-03-18
CARDIOBEEPER CB-12L (K965101)Meridian Medical Technologies, Inc.1997-03-17
MCL 29 DERMABLATE ERBIUM LASER SYSTEM (K964128)Aesculap-Meditec GmbH1997-03-17
DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0 (K964987)Datascope Corp.1997-03-17
MEADOX EXXCEL EPTFE VASCULAR GRAFT (K962433)Meadox Medicals, Div. Boston Scientific Corp.1997-03-17
AMICAS WEB/INTRANET IMAGE SERVER (K970064)Autocyt Group, Inc.1997-03-17
CPC PROBE (K961380)Carl Zeiss, Inc.1997-03-17
ACUMED SUTURE WASHER (K965028)Acu Med, Inc.1997-03-17
EMERGENCY RELIEF KIT SYSTEM (K964029)Baxter Healthcare Corp1997-03-17
SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM (K964416)Synthes (Usa)1997-03-17
ABC IN-LINE BLOOD SAMPLING KIT (K955663)Utah Medical Products, Inc.1997-03-17
IL0292 DP ECHOPORT (K970555)Smith1997-03-17
NEURO-TRAIN II (2) (K970155)Sterne Equipment Co., Ltd.1997-03-17
VINGMED SOUND COLOR FLOW MAPPING SYSTEM. SYSTEM FIVE (K963315)Vingmed Sound, Inc.1997-03-17
ELEVATING AND REMOVABLE LEG AND REMOVABLE ARM WHEELCHAIR (K964932)L & M Resource Information Service, Inc.1997-03-17
LIBERTY ANTERIOR SPINAL SYSTEM (K965193)Sofamor Danek USA,Inc.1997-03-17
DGH MODEL 9000 (K965127)Dgh Technology, Inc.1997-03-17
SINGLE TOOT ABUTMENT SYSTEM (STA OR ST ABUTMENT ) FOR SINGLE OOTH CEMENT RETAINED RESTORATIONS (K965077)Implant Innovations, Inc.1997-03-17
SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM (K970034)Hewlett-Packard Co.1997-03-17
RADX SYSTEM (K965203)Electro Medical Systems, Inc.1997-03-17
KIRSCHNER KNEE MODIFIED (K961021)Biomet, Inc.1997-03-17
BLUE CHIP GERMICIDAL CLEANER & DEODORANT (K970825)S.C. Johnson Professional1997-03-14
POROUS MEDIA DBF23 REUSABLE RESPIRATORY FILTER (K965020)Porous Media Corp.1997-03-14
ISOLA TWISTER CONNECTOR (K965046)Acromed Corp.1997-03-14
MOBILE OPERATING TABLE 1132.01 (K970807)Stierlen-Maquet AG1997-03-14
ULTRACAL XS (K970114)Ultradent Products, Inc.1997-03-14
NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE (K964117)Kawasumi Laboratories Co., Ltd.1997-03-14
OOLI-U(TONGUE SCRAPER) (K970042)Telefax Intl.1997-03-14
TOPAZ 30 SURGICAL LASER SYSTEM (K965015)Esc Medical Systems, Inc.1997-03-14
FLEXIFLO FLOCATOR SMALL BOWEL FEEDING SYSTEM (K950017)Ross Products1997-03-14
REGIONAL ANESTHESIA TRAYS (K965017)Smiths Industries Medical Systems, Inc.1997-03-14
HOWMEDICA MAINSTAY ANCHOR (K965175)Howmedica Corp.1997-03-13
MANAN D BAG (K961986)Manan Medical Products, Inc.1997-03-13
LINK CERCLAGE WIRE SYSTEM (K970084)Turnkey Intergration USA, Inc.1997-03-13
IMPLEX REPLACEMENT ACETABULAR CUP INSERT (K964882)Implex Corp.1997-03-13
PERSONAL CATHETER (K970704)Rochester Medical Corp.1997-03-13
BIORIGID NAIL TIBIA (K970013)Aap GmbH and Co. Betriebs KG1997-03-13
PROXIMAL FEMORAL NAIL (PFN) SYSTEM (K970097)Synthes (Usa)1997-03-13
MEDVISION PERSONAL MONITOR (K961343)Medvision, Inc.1997-03-13
SLS CHROMOS 694 QD RUBY LASER TO BE RENAMED MEHL QD RUBY LASER SYSTEM FOR HAIR REMOVAL (K962109)Classy Lady by Mehl of Puerto Rico, Inc.1997-03-13
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM (K965145)Depuy, Inc.1997-03-13
HOLTER DIGICORDER WITH PACER OPTION (MODEL 483) (K963174)Del Mar Avionics1997-03-13
TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN (K962723)Trace America, Inc.1997-03-13
NEW STAR MODEL 130 6-WATT ND: YAG LASER SYSTEM (K962791)New Star Lasers, Inc.1997-03-13
HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR (K965164)Howmedica Corp.1997-03-13
SYSMEX SE/RAM-1 (K964375)Sysmex Corp.1997-03-13
TRUE/FIT FEMORAL INTRAMEDULLARY ROD SYSTEM (K961360)Encore Orthopedics, Inc.1997-03-13
CONTRAST MEDIA SET (K955179)B.Braun Medical, Inc.1997-03-12
TARGOGRID (K970037)Daum GmbH1997-03-12
RFG-3CF (K965182)Radionics, Inc.1997-03-12
PROTIME MICROCOAGULATION SYSTEM (K961835)International Technidyne Corp.1997-03-12
SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER) (K965161)Sectra-Imtec AB1997-03-12
WIDEX MODEL SENSO DIGITAL (C9) (K965254)Widex Hearing Aid Co., Inc.1997-03-12
MS-2000 (K961144)Touritu Engineering Co., Inc.1997-03-12
INTEGRATED VISUALIZATION SYSTEM (K970598)Urohealth, Inc.1997-03-12
HEARTPORT NEEDLE TROCAR (K965051)Heartport, Inc.1997-03-12
EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND INSTATRACE ADULT DIAPHORETIC FOAM ECG ELECTRODE CONM (K963787)Conmedcorp1997-03-11
QUANTITATIVE SENTINEL SYSTEM (K963608)Quantitative Medicine, Inc.1997-03-11
SERIES 7600 MOBILE DIGITAL C-ARM (K970063)Ge Dec Medical Systems1997-03-11
DIFFUSER PANEL (K970240)Focused Viewer, Inc.1997-03-11
MEDLINE ADMISSION KITS (K965107)Medline Industries, Inc.1997-03-11
ADAPTIVE COMPRESSION - CLASS D/ CLASS D AGCI (K970430)Midwest City Hearing Aid Center1997-03-11
FORCE ARGON II ARGON ENHANCED ELECTROSURGICAL SYSTEM (K964636)Valleylab, Inc.1997-03-11
PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE) (K962605)Surgicot, Inc.1997-03-11
CYTOPLAST GBR (K964342)Osteogenics Co.1997-03-11
VESSEL DILATOR (K963388)Maxxim Medical1997-03-11
URIC ACID (LIQUID) REAGENT SET (K970560)Pointe Scientific, Inc.,1997-03-11
TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM (K961707)Sorenson Critical Care1997-03-11
LIFESTYLE BREAK THRU (POLYMACON) (K965012)The Lifestyle Co., Inc.1997-03-11
SLEEP SYSTEM FOR CLINICS & RESEARCH (K955841)Compumedics Ptd , Ltd.1997-03-11
C.A.R.E. VISION FOR THE SOMATOM PLUS 4 CT SCANNER (K965004)Siemens Medical Solutions USA, Inc.1997-03-11
PROXIMATE DISPOSABLE SKIN STAPLER (K970079)Ethicon Endo-Surgery, Inc.1997-03-11
PREPOWDERED LATEX EXAMINATION GLOVE (K970313)Besglove Healthcare Sdn. Bhd.1997-03-11
VISTA BRITE TIP CATHETERS (K965211)Cordis Corp.1997-03-11
KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE (K970427)Karl Storz Endoscopy1997-03-11
SOOTHING WATER-FILLED TEETHER (K965082)Consolidated Stores Corp.1997-03-11
POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER (K964979)Porous Media Corp.1997-03-11
INTRAORAL MANDIBULAR DISTRACTION DEVICE (K970256)Medicon EG1997-03-11
SMARTGUIDE (K963894)Ferguson Medical1997-03-11
LIFESTYLE 4-VUE (POLYMACON) HYDROPHILIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR (K963001)Permeable Technologies, Inc.1997-03-11
ROCCOBAROCCO & PRO-DYNAMIX (K965170)Michelangelo, Inc.1997-03-11
ULTRAFREE STERILE LATEX POWDER-FREE SURGICAL GLOVES (K964474)Allegiance Healthcare Corp.1997-03-11
VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION (K963273)Smv America1997-03-11
CONTACT LENSES METRO-G 3X (HIOXIFILCON B) (K964902)Metro Optics of Austin, Inc.1997-03-11
GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS (K970372)Precision Endoscopy of America, Inc.1997-03-11
NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT (K965058)Nichols Institute Diagnostics1997-03-11
NASP HYDROCOLLOID DRESSING (REGULAR OR THIN) (K964231)North American Sterilization & Packaging Co.1997-03-10
LIQUICHECK URINE TOXICOLOGY NEGATIVE CONTROL (K970666)Bio-Rad1997-03-10
IMMULITE OPIATES SCREEN/CONTROL MODULE (K962323)Diagnostic Products Corp.1997-03-10
3M 1830 FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK AND 3M 1830FS FLUID BLOCK ANTI-FOG TIE-ON SURGICAL MASK WITH FACE SHIE (K965043)Minnesota Mining and Mfg. Co.1997-03-10
VASCUTEK TWILLWEAVE VASCULAR GRAFT (K964959)Vascutek, Ltd.1997-03-10
HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT (K970477)Sebia1997-03-10
EPISCREEN (K970357)Epitope, Inc.1997-03-10
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Track 1997 automatically

Every clearance here is in the API, with alerts when new ones post.