Atlas FDA

1997

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

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RecordFirmDate
INTUBATION ENDOSCOPE AND INTRODUCER SHEATH (K970107)Urohealth Systems, Inc.1997-11-18
VINYL PATIENT EXAMINATION GLOVES POWDER-FREE (K973998)Everrise Glove Products Co., Ltd.1997-11-18
Hi Coat Powder Free Latex Patient Examination Gloves (K972539)P.T. Latexindo Tobaperkasa1997-11-18
ULTRACELL PACKING WITH SLEEVE (K973085)Ultracell Medical Technologies, Inc.1997-11-18
HYDROTEC LOW AIR LOSS THERAPY BED (K970363)Apex Metal, Inc.1997-11-17
KETAC-FIL APLICAP PLUS (K973262)Espe GmbH & Co. Kg.1997-11-17
HUNTER 0.014 INCH SUPER SOFT / HUNTER O.014 INCH SOFT GUIDE WIRES W/THROMBORESISTANT PC COATING (K970938)Biocompatibles Cardiovascular, Inc.1997-11-17
BACT/ALERT CULTURE BOTTLES (K973305)Organon Teknika Corp.1997-11-17
VITAL-PORT INFUSION PAL (K971140)Med Institute, Inc.1997-11-17
CAROLINE GUIDE/DELIA LOCALIZER (K973277)Surgical Solutions, Inc.1997-11-17
DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/ (K970505)Dade Intl., Inc.1997-11-17
CHAD TOTAL O2 DELIVERY SYSTEM (K971889)Chad Therapeutics, Inc.1997-11-17
POSITIVE PRESSURE CONNECTOR (K973167)Icu Medical, Inc.1997-11-17
AIRTEC2 LOW AIR LOSS THERAPY BED (K970364)Apex Metal, Inc.1997-11-17
VERSAETCH (K973257)Centrix, Inc.1997-11-17
IBC CARDIAC SUCTION WARD (K963756)International Biophysics Corp.1997-11-14
SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER (K972109)General Surgical Innovations1997-11-14
MOST HEX INTRAMEDULLARY (I/M) STEM (K973087)Sulzer Orthopedics, Inc.1997-11-14
NPB-295 PULSE OXIMETER (K973147)Nellcor Puritan Bennett, Inc.1997-11-14
AMERICAN DENTAL PRODUCTS HB-35 DESENSITIZER WITH FLUORIDE (K973185)American Dental Products, Inc.1997-11-14
PASCO MIC AND MIC/ID PANELS (K973317)Pasco Laboratories, Inc.1997-11-14
BONE-LOCK (K954030)Leibinger GmbH1997-11-14
RASCAL POWER CHAIR (K972370)Electric Mobility, LLC1997-11-14
SYNTEC TRUE LIGHT ENDOILLUMIINATOR WITH PICK (K973290)Vaughan Weeks1997-11-14
RESTORE (A.K.A. CAPSURE) (K971359)Nebl, Inc.1997-11-14
SENSOR PAD (K973450)Inventive Products, Inc.1997-11-14
NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEM (K964540)Puritan Bennett Corp.1997-11-14
PROGESTERONE ELISA (K973898)Kmi Diagnostics, Inc.1997-11-13
IMCOR EXTERNALLY HEXED, SELF-TAPPING SCREW IMPLANT SURGICAL DRILLING SYSTEM (K973049)Imcor1997-11-13
CYNOSURE PHOTOGENICA ER LASER (K973498)Cynosure, Inc.1997-11-13
DURALASTIC ANATOMICAL NASAL IMPLANTS (K973573)Hanson Medical, Inc.1997-11-13
IMAGING JET SYSTEM (K970782)General Robotic Devices, Inc.1997-11-13
TED 191 (K963177)Teledyne Brown Engineering1997-11-13
CARR RIGID CONTAINER SYSTEM (K972138)Carr Metal Products, Inc.1997-11-13
SILICONE CARVING BLOCK (K973728)Hanson Medical, Inc.1997-11-13
ENDOPATH ULTRA-RETRACTOR/ ENDOPATH VESSEL DISSECTOR (K973139)Ethicon Endo-Surgery, Inc.1997-11-13
PIVOTAL SCISSOR (K972510)Urohealth Systems, Inc.1997-11-13
DHEA-S (K973897)Kmi Diagnostics, Inc.1997-11-13
ELECSYS VITAMIN B12 ASSAY (K973702)Boehringer Mannheim Corp.1997-11-13
SNT LINAC ACCESSORIES (K971893)Surgical Navigation Technologies, Inc.1997-11-13
SERODIA TP-PA (K971502)Scimedx Tekfile Services1997-11-13
ATOMISOR (K970844)Medical Consulting Service, Inc.1997-11-13
LANG DENTAL RESIN A97 FIBRED PINK (K972553)Lang Dental Mfg. Co., Inc.1997-11-13
ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30 (K974001)Diagnostic Chemicals , Ltd.1997-11-13
OPTI-MAX ANGLED CROWN POST FOR EXTERNALLY-HEXED IMPLANTS, IN 15 DEGREE AND 25 DEGREE INCLINATIONS. FOR IMPLANTS 3.3MM, 4 (K972769)Opti-Max1997-11-13
EYE SYS VISTA (K973756)Eyesys Technologies, Inc.1997-11-13
VIRGO PANCO KIT (K973824)Hemagen Diagnostics, Inc.1997-11-13
PR 3 ANTIBODY KIT (K973823)Hemagen Diagnostics, Inc.1997-11-13
FLUID MANAGEMENT SYSTEM (K972284)Belmont Instrument Corp.1997-11-13
REALVIEW TELEMEDICINE SYSTEM (K973065)Vcom Systems, Inc.1997-11-13
PEDO CUSH PEDO CUDDLE (K972446)Cavity Free Kids, Inc.1997-11-13
PLUS EPF ACETABULAR CUP (K972931)Hhl Consulting1997-11-13
IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEM (K971868)Marquette Electronics, Inc.1997-11-13
HOOK ELECTRODE, NEEDLE ELECTRODE, COAGULATION BUTTON ELECTRODE (K973341)Richard Wolf Medical Instruments Corp.1997-11-13
VIRGO ANCA SCREEN KIT (K973822)Hemagen Diagnostics, Inc.1997-11-13
ALLEGIANCE KWIK HEAT WARM PERINEAL PACK (K973770)Allegiance Healthcare Corp.1997-11-13
PLUS-FIT ACETABULAR CUP (K973077)Plus Orthopedics1997-11-13
CASTLE SERIES 100 STEAM STERILIZERS (STRAIGHTLINE) (K970907)Getinge/Castle, Inc.1997-11-12
DEPUY DURALOC ACETABULAR CUP SYSTEM (K972596)Depuy, Inc.1997-11-12
ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS (K973583)Schiapparelli Biosystems, Inc.1997-11-12
ELECSYS FOLATE (K973674)Boehringer Mannheim Corp.1997-11-12
ODI COMPRESSION HIP SCREW SYSTEM (K971993)Orthopaedic Designs, Inc.1997-11-12
1.4 FR MAPCATH SENSOR STYLET (K973057)Navion Biomedical Corp.1997-11-12
CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90) (K970661)Baxter Healthcare Corp1997-11-12
NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101 (K971803)Neurotronics, Inc.1997-11-12
BCI MODEL 6004 NIBP MONITOR (6004) (K970801)Bci Intl., Inc.1997-11-12
BONE GRAFT SCREW SYSTEM (K973056)Bicon, Inc.1997-11-12
ACE PRIMIDONE REAGENT, AED CALIBRATORS (K973582)Schiapparelli Biosystems, Inc.1997-11-12
MIE FALCON, DATEX ENGSTROM FLEXIMA II (K971030)Medical and Industrial Equipment1997-11-12
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007 (K973850)Alexander Mfg. Co.1997-11-12
ADJUSTABLE THERASNORE (K973038)Distar, Inc.1997-11-12
TUTTNAUER PREVACUUM TABLE AUTOCLAVE (K962282)Tuttnauer U.S.A Co, Ltd.1997-11-12
3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRES (K973036)3M Healthcare1997-11-12
BONE GRAFT HARVESTER (K973560)Ds Mfg., Inc.1997-11-12
SIENET MAGICWEB (WEB SERVER), SIENET MAGICLINK I (ISI-GATEWAY) (K973131)Siemens Medical Solutions USA, Inc.1997-11-12
HEART ACCESS PLUS CARDIAC EVENT RECORDER (K973141)Paceart, Inc.1997-11-12
ACE VALPROIC ACID REAGENT, AED CALIBRATORS (K973581)Schiapparelli Biosystems, Inc.1997-11-12
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) (K970654)Baxter Healthcare Corp1997-11-12
PLANMED CYTOGUIDE (K973493)Planmed OY1997-11-10
ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (K974075)Beckman Instruments, Inc.1997-11-10
FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE (K965228)United States Surgical, A Division of Tyco Healthc1997-11-10
APO-TEK LP(A) (K970302)Perimmune, Inc.1997-11-10
MITEK NON ABSORBABLE POLYPROPYLENE H FIX (K973009)Mitek Products1997-11-10
RAVEN DRY PRINTER (K972660)Sterling Diagnostic Imaging, Inc.1997-11-10
THE C-FIT & DC-FIT ACETABULAR CUP SYSTEM (K972995)Corin USA1997-11-10
THE CORIFIX LIGAMENT ANCHOR (K973005)Corin USA1997-11-10
SYNTHES MINI LENGTHENING APPARATUS (K973018)Synthes (Usa)1997-11-10
AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION (K972997)Dan Med, Inc.1997-11-10
INTELECT LEGEND ULTRASOUND (K973024)Chattanooga Group, Inc.1997-11-10
MAMMOTEST ADAPTER DRIVER (K973400)Fischer Imaging Corp.1997-11-10
PHILIPS INTEGRIS V5000 AND BV5000 (K973482)Philips Medical Systems North America, Inc.1997-11-10
SIREMOBIL CO2 (K973598)Siemens Medical Solutions USA, Inc.1997-11-10
INFLATABLE POSITIONING CUSHIONS (K973915)Kci New Technologies, Inc.1997-11-10
MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SYSTEM (K973113)Boston Scientific Corp1997-11-10
IMX CA 15-3 (K964407)Abbott Laboratories1997-11-10
REALTIME 3D DIAGNOSTIC WORKSTATION (K973010)Siemens Medical Solutions USA, Inc.1997-11-10
KODAK DIGITAL SCIENCE-DENTAL IMAGE VIEWER (K973476)Eastman Kodak Company1997-11-10
PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED) (K973059)Sri Johani Sdn. Bhd.1997-11-07
GESCO PER-Q-CATH PICC CATHETERS (K971990)Bard Access Systems, Inc.1997-11-07
SPINAL CONCEPTS, INC., UNIVERSAL BONE PLATE SYSTEM II (K973586)Spinal Concepts, Inc.1997-11-07
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Track 1997 automatically

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