Atlas FDA

1997

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

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RecordFirmDate
FUKUDA DENSHI DYNASCOPE MODEL DS-5800 CENTRAL STATION MONITOR (K970585)Fukuda Denshi USA, Inc.1997-09-09
PUNCTUAL OCCLUDER (K972523)Odyssey Medical, Inc.1997-09-09
CEQUAL-QUANTITATIVE ANALYSIS FOR CARDIOLITE EXECUTING ON THE MEDASYS DIGITAL SYSTEMS COMPUTER (K972509)Nuccardiac Software, Inc.1997-09-08
AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS (K964238)Aircast, Inc.1997-09-08
CIMPAT N (K972485)Arent, Fox, Kintner, Plotkin & Kahn1997-09-08
CHASE THORACIC CATHETER (K971023)Chase Medical, Inc.1997-09-08
5 STAR MEDICAL ENDOSCOPE (K963354)Five Star Medical, Inc.1997-09-08
DYE STOP AND SAVE - QUICKFILL (K971624)Shepherd Laboratories, Inc.1997-09-08
K 15 AUDIOMETER (K972221)American Electromedics Corp.1997-09-08
DIGITIZER DIRECTOR (HSC025-01) (K972191)Howtek, Inc.1997-09-08
DRY & STORE (K972776)Ear Technology Corp.1997-09-08
MICROSCAN DRIED GRAM POSITIVE MIC/COMBO PANELS LEVOFLOXACIN (K972688)Dade Microscan, Inc.1997-09-08
STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS (K972030)Oxoid , Ltd.1997-09-08
LANTIS TREATSTATION (K972275)Siemens Medical Solutions USA, Inc.1997-09-08
LOGIQ 1000 DIAGNOSTIC ULTRSOUND SYSTEM (K960527)GE Medical Systems1997-09-08
BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE (K964597)Biosurgical Corp.1997-09-08
GRASPING FORCEPS, RIGHT AND LEFT CURVED (K972519)Richard Wolf Medical Instruments Corp.1997-09-08
KARL STORZ CONTACT NASAL MICRO-ENDOSCOPES (K972855)KARL STORZ Endoscopy-America, Inc.1997-09-08
DRIED GRAM-POSITIVE MIC/COMBO PANELS (K972524)Dade Intl., Inc.1997-09-08
HIPALLAUR 51 (K972951)Aurex Precious Metal Industries (Pty)Ltd1997-09-05
AUREBOND 51 (K972952)Aurex Precious Metal Industries (Pty)Ltd1997-09-05
RESECTOSCOPE SAFETY SHEATH (K972210)Conceptus, Inc.1997-09-05
OLYMPIX MINI-PASTEURMATIC (58210) (K972193)Olympic Medical Corp.1997-09-05
IMATION SE-196 LASER IMAGER (K972163)Imation Corp.1997-09-05
P REFERENCE TPS (TREATMENT PLANNING SOFTWARE) 1.1 (K970464)Northwest Medical Physics Equipment, Inc.1997-09-05
EZCHEK/HBA BLOOD COLLECTION KIT (K971919)Flexsite Diagnostics, Inc.1997-09-05
PALAUREX 76KF (K972953)Aurex Precious Metal Industries (Pty)Ltd1997-09-05
TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP) (K972735)Mednet Locator, Inc.1997-09-05
MEDLITE IV Q-SWITCHED, FREQUENCY DOUBLED, ND:YAG LASER (K970808)Continuum Biomedical, Inc.1997-09-05
UNISURGE INTERFACE P (K972178)Unisurge Holding, Inc.1997-09-05
ALPHA 7000 QUADRATURE WRIST COIL (K972205)Usa Instruments, Inc.1997-09-05
FLEX-NECK PD CATHETER (K970159)Janin Group, Inc.1997-09-05
PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP) (K972734)Mednet Locator, Inc.1997-09-05
SIDEXIS DIGITAL RADIOGRAPHY SYSTEM (K972168)Pelton & Crane Co.1997-09-05
VERA SOLDER (K972533)Aalba Dent, Inc.1997-09-05
PRISMA (K972998)Siemens Hearing Instruments, Inc.1997-09-05
XPS STRAIGHTSHOT MICRORESECTOR (K972453)Xomed, Inc.1997-09-05
CAUSSE PISTON (K972737)Mednet Locator, Inc.1997-09-05
KT AIR BED (K970468)Kinetic Concepts, Inc.1997-09-05
PALCERAM 56 (K972955)Aurex Precious Metal Industries (Pty)Ltd1997-09-05
POWDER FREE SYNTHETIC EXAMINATION GLOVES (K971356)Arista Latindo Industrial Ltd. P.T1997-09-05
AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR (K971492)Bei Medical Systems Co., Inc.1997-09-05
HIPALLAUR 19 (K972950)Aurex Precious Metal Industries (Pty)Ltd1997-09-05
PALCERAM 82SF (K972956)Aurex Precious Metal Industries (Pty)Ltd1997-09-05
PALAUREX 78 (K972954)Aurex Precious Metal Industries (Pty)Ltd1997-09-05
ALFALLOY (K972534)Aalba Dent, Inc.1997-09-05
SC9000/SC9015 MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER (K973222)Siemens Medical Solutions USA, Inc.1997-09-04
BKMI DISPOSABLE SYRINGE (K971487)Sumi Salud C.A.1997-09-04
E. CAM COINCIDENCE MODE (CM) (K970627)Siemens Medical Solutions USA, Inc.1997-09-04
RADIOTHERAPEUTICS RF GENERATOR. MODEL #RF-2000 (K972441)Radiotherapeutics Corp.1997-09-04
STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT (K972367)Stryker Instruments1997-09-04
SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM (K972516)Synthes (Usa)1997-09-04
UNICAP PHADIATOP (K972364)Pharmacia, Inc.1997-09-04
SULLIVAN HUMIDAIRE HEATED HUMIDIFIER (K971260)Resmed Corp1997-09-04
AP-4000, AIR PULSE SENSORY STIMULATOR (K964815)Pentax Precision Instrument Corp.1997-09-04
VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300) (K973030)Johnson & Johnson Clinical Diagnostics, Inc.1997-09-04
FLY THROUGH (K971717)Siemens Medical Solutions USA, Inc.1997-09-03
CLINIJEL (K970581)Hospicon Products1997-09-03
VIEW ARCHIVING STATION (K971176)Electromed Intl., Ltd.1997-09-03
ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOPE ADAPTER,IN-LINE SPECIMEN TRAP (K972139)Davis & Geck, Inc.1997-09-03
ROYALE BRAND LATEX CONDOMS (SILICONE)-COLORED/ASSORTED COLORS (K971132)G. Premjee (Usa), Inc.1997-09-03
FACE MASK, SURGICAL MASK, NON-STERILE (K970835)Tucker & Associates1997-09-03
VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER (K964908)Sorin Biomedical, Inc.1997-09-03
30 CC AND 40 CC SUB-9 NITINOL AND 30 AND 40 CC SUB-9 STAINLESS STEEL (K972113)Boston Scientific Corp1997-09-02
QUICKSCREEN ONE STEP METHAMPHETAMINE TEST(9065) (K972556)Phamatech1997-09-02
FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) (K972720)Monobind1997-09-02
PHILIPS EASYVISION (K972103)Philips Medical Systems North America, Inc.1997-09-02
ARRIPRO 35 ST/TV (K973115)Arnold & Richter Cine Technik1997-09-02
ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT (K971458)Diagnostic Specialties1997-09-02
SMART SET (K972663)Top Spins, Inc.1997-09-02
AMBIDERM (K971102)Supertex Industrial, S.A. DE C.V.1997-08-29
AMS FOREIGN BODY EXTRATOR (K972091)American Medical Systems, Inc.1997-08-29
3M AURORA SYSTEM (K972355)3M Company1997-08-29
URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BILIARY CATHETER, URESIL NEPHRO-URETERAL S (K972583)Uresil Corp.1997-08-29
PREGNACOL PREGNANCY TEST (K972606)Immunostics Inc.,1997-08-29
EASY BOND (K972421)Parkell, Inc.1997-08-29
OPUS S MODEL 4121 AND 4124 PACEMAKERS (K970072)Ela Medical, Inc.1997-08-29
VOLKER HOSPITAL BED, MODEL K960 (K972115)Volker Healthcare, Inc.1997-08-29
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER (K970296)Boston Scientific Corp1997-08-29
FRESHCELLS (K972414)Diagnostic Hybrids, Inc.1997-08-29
CRYO CHECK INR VALIDATION SET (K971219)Precision Biologicals, Inc.1997-08-29
LIFETECH CASSETTE (K960756)Lifetech Systems, Inc.1997-08-29
LINK CEMENT PLUG (K972411)Turnkey Intergration USA, Inc.1997-08-29
W.A. (K971200)W.A. Rubbermate Co., Ltd.1997-08-29
QUICKVUE ONE-STEP HCG-URINE (K972742)Quidel Corp.1997-08-29
SHARPS SHUTTLE (K972279)Sage Products, Inc.1997-08-29
MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM (K970347)Paladin Medical, Inc.1997-08-29
DREAM CATCHER (K972122)Rest Technologies, Inc.1997-08-29
SPOROX TEST STRIPS (K972035)Serim Research Corp.1997-08-29
CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL (K972976)More Diagnostics1997-08-29
MSI MAGNA-STYM (K972055)Microvas Systems, Inc.1997-08-29
ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY (K964799)Ormed GmbH1997-08-29
ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM (K971998)Bayer Corp.1997-08-29
BRONCHIAL BLOCKER (K962167)Cook, Inc.1997-08-29
CARDS Q.S. HCG-URINE; AND CONCISE PERFORMANCE PLUS HCG-URINE (K972748)Quidel Corp.1997-08-29
ARTOCOOL-S WATER CIRCULATING COLD PACK (K964354)Ormed GmbH1997-08-29
AIA-PACK TSH 3RD-GEN ASSAY (K972586)Tosoh Medics, Inc.1997-08-29
BTI CORTICAL BONE SCREWS (K972403)Biodynamic Technologies, Inc.1997-08-29
AG CHEMISTRY ANALYZER SYSTEM (K972409)Landmark Scientific, Inc.1997-08-28
SODIUM CHLORIDE INHALATION SOLUTION, USP (K972466)Holopack International, LP1997-08-28
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Track 1997 automatically

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