Atlas FDA

1990

4,721 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SAFE SYTE I.V. CATHETER PLACEMENT UNIT (K904648)Deseret Medical, Inc.1990-12-14
NORTA SILICONE ELASTOMER COATED LATEX BALLOON CATH (K900509)Medical Latex Corp.1990-12-14
CAP-AID (K904107)Nda Systems1990-12-14
AVI MODEL 4206 MANIFOLD CHECKVALVE IV ADMIN. SET (K902858)3M Avi, Inc.1990-12-14
ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20 (K902723)Electromedics, Inc.1990-12-13
COULTER CK-MB ISOENZYME REAGENT (K904866)Coulter Electronics, Inc.1990-12-13
WRP FOLEYCATH (K903777)Wembley Rubber Products (M) Sdn Bhd1990-12-13
QUALTEX SKIN MARKER (K904559)Qualtex, Inc.1990-12-13
TURBIQUANT MYOGLOBIN (K905202)Behring Diagnostics, Inc.1990-12-13
QUALTURE (K903470)Future Medical Technologies Intl., Inc.1990-12-13
DIASTAT ANTI-LA (SS-B) (K905193)Shield Diagnostics, Ltd.1990-12-13
ABL510 BLOOD GAS SYSTEM (K904513)Radiometer America, Inc.1990-12-13
PATHODX HERPES TYPING (K904167)Diagnostic Products Corp.1990-12-13
QUALTEX SURGICAL DRAPE (K904960)Deroyal Industries, Inc.1990-12-13
INTERTECH(TM) HEAT AND MOISTURE EXCHANGER (K903519)Intertech Resources, Inc.1990-12-13
DISTAT ANTI-DSDNA KIT (K905386)Shield Diagnostics, Ltd.1990-12-13
ABUSCREEN ONTRAK FOR THC (K904856)Roche Diagnostic Systems, Inc.1990-12-13
PULMOVISION CHEST RADIOGRAPHY X-RAY SYSTEM (K904144)Mallinckrodt Group, Inc.1990-12-13
ACTIVE ADAPTER (K904506)Beacon Laboratories, Inc.1990-12-13
HUGH YOUNG II UROLOGICAL X-RAY SYSTEM (K904147)Mallinckrodt Group, Inc.1990-12-13
CARDIOFAX ECG-8830A (K904758)Nihon Kohden America, Inc.1990-12-13
MINNOW PENILE IMPLANT PROTECTOR (K904262)Ruja-Med Medical Marketing1990-12-13
DIASTAT ANTI-RO (SS-A) (K905194)Shield Diagnostics, Ltd.1990-12-13
CO2 LASERS AND INFRAGUIDE DELIVERY SYSTEM (K904423)Heraeus Lasersonics, Inc.1990-12-13
1-CUT ACL GRAFT KNIFE (K905380)Depuy, Inc.1990-12-13
NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT (K903995)Sigma Chemical Co.1990-12-13
MODELS 4000,4900,6000,8000,8900, LUXUS 6&100/1700 (K904444)Heraeus Lasersonics, Inc.1990-12-13
DSL CK-MB (DSL #3200) (K904721)Diagnostic Systems Laboratories, Inc.1990-12-13
SODIUM CHLORIDE SOLUTION (K903347)Superior Healthcare Group, Inc.1990-12-13
NEURO VISION RADIOGRAPHIC X-RAY SYSTEM (K904146)Mallinckrodt Group, Inc.1990-12-13
HYDRA VISION UROLOGICAL X-RAY SYSTEM (K904145)Mallinckrodt Group, Inc.1990-12-13
PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA. (K901605)Phoenix Laser Systems, Inc.1990-12-13
POSITIVE CONTROL PAD ALLERGEN/FOOD ALLERGEN SCREEN (K905176)Quidel Corp.1990-12-13
ANGEFLATOR(TM) (K902377)Angeion Corp.1990-12-13
MULTILASE 45 (K904227)Laser Photonics, Inc.1990-12-12
MULTILASE 60 (K904229)Laser Photonics, Inc.1990-12-12
HOOD, OPERATING, SURGICAL (K904969)Chicago Assoc. For Retarded Citizens1990-12-12
NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER (K904566)Cobe Laboratories, Inc.1990-12-12
KALTOSTAT WOUND DRESSING (K904488)Calgon Vestal Div.1990-12-12
NA NEEDLES (K904667)Olympus Corp.1990-12-12
PEEWEE REPLACEMENT GASTROSTOMY TUBE (K903662)Biosearch Medical Products, Inc.1990-12-12
REMOTE CONTROLLED X-RAY DIAGNOSTIC RS-110 (K905153)Shimadzu Medical Systems1990-12-11
BLADE PLATE (K905352)O'Tec Corp.1990-12-11
HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173 (K905284)Amresco, Inc.1990-12-11
RUSH PIN (K905341)O'Tec Corp.1990-12-11
SIMULTEST T & B CELL TEST,ANTI-LEU-4 FITC & 12 PE (K904209)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-12-11
ROUND STAPLE (K905364)O'Tec Corp.1990-12-11
STEINMAN PIN, THREADED (K905336)O'Tec Corp.1990-12-11
BARBED SQUARE STAPLE (K905362)O'Tec Corp.1990-12-11
K-WIRE (K905345)O'Tec Corp.1990-12-11
QUICKANCHOR (TM) (K904436)Mitek Surgical Products, Inc.1990-12-11
KNOWLES PIN (K905344)O'Tec Corp.1990-12-11
STEINMAN PIN (K905337)O'Tec Corp.1990-12-11
FIXATION STAPLE (K905363)O'Tec Corp.1990-12-11
SIDE PLATE (K905338)O'Tec Corp.1990-12-11
OSTEOGRAF/N NATURAL HYDROXYLAPATITE, 40-60 MESH (K902295)Ceramed Corp.1990-12-11
DISPOSABLE SURGICAL TOWEL (NON-STERILE) (K905005)Marand Products, Inc.1990-12-11
INTERVERTEBRAL DISC RONGEUR (K903151)Von Zeppelin GmbH1990-12-11
AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116 (K904004)Amresco, Inc.1990-12-11
REMOTE CONTROLLED X-RAY DIAG. RSZ-200 (K905152)Shimadzu Medical Systems1990-12-11
HANSEN-STREET TYPE INTRAMEDULLARY NAIL (K905348)O'Tec Corp.1990-12-11
AUSTIN MOORE TYPE HIP PROTHESIS (K905349)O'Tec Corp.1990-12-11
LAG SCREW (K905342)O'Tec Corp.1990-12-11
THOMPSON TYPE HIP PROSTHESIS (K905334)O'Tec Corp.1990-12-11
DOA LIQUID MULTI-ANALYTE DRUGS OF ABUSE CONTROLS (K904905)Medical Analysis Systems, Inc.1990-12-11
TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL (K905226)Enzyme Technology, Inc.1990-12-11
JEWETT HIP NAIL (K905346)O'Tec Corp.1990-12-11
MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ (K905228)Baxter Healthcare Corp1990-12-10
THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000 (K903489)Pegasus Research Corp.1990-12-10
INSULATED ELECTRODES AND LAPAROSCOPIC PROBICS (K904173)Baxter Healthcare Corp1990-12-10
KNIGHT SACRAL SCREW (K902775)Danek Medical, Inc.1990-12-10
TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS) (K901005)Danek Medical, Inc.1990-12-10
VESSEL DILATOR (K904476)Datascope Corp.1990-12-10
KLEARTEX LATEX SURGEONS GLOVES (K904361)Kleartex Sdn Bhd1990-12-07
CHILDRENS SUNGLASSES (K902225)Jasco Products Co., Inc.1990-12-07
HDL CHOLESTEROL CONTROL (K904872)Analytical Control Systems, Inc.1990-12-07
SURGILASE SL 50/60 GOLD SURGICAL LASER SYSTEM (K904203)Surgilase, Inc.1990-12-07
ENDOSCOPIC LIGHT SOURCE 250 ENDO (K903790)Orlux Engineering and Instrumentation1990-12-07
TURBO-RAST SPECIFIC IGE ASSAY (K904330)Ventrex Laboratories, Inc.1990-12-07
NIDEK INC. MODEL AC-2000 DERM (K904402)Nidek, Inc.1990-12-07
HEARING AID, UNITRON MODEL UM60-UH (K904576)Unitron Industries, Inc.1990-12-07
INGLAT-O-BALL (K904774)Milex Products, Inc.1990-12-07
CONQUEST DIRECT FILLING COMPOSITE (DFC) (K904724)Jeneric/Pentron, Inc.1990-12-07
DIASTAT ANTI-SM (K905191)Shield Diagnostics, Ltd.1990-12-07
LDL-DIRECT CONTROLS (K902740)Isolab, Inc.1990-12-07
BATTERY-POWERED TOOTHBRUSH (K904401)The B & F System, Inc.1990-12-07
DIASTAT ANTI-SM/RNP (K905192)Shield Diagnostics, Ltd.1990-12-07
DIASTAT ENA PROFILE (K905190)Shield Diagnostics, Ltd.1990-12-07
MODIFIED CASS SYSTEM (K902488)Medical Instrumentation & Diagnostics Corp.(Midco)1990-12-07
QUALITONE ULTRA CANAL GENESIS (K904730)Qualitone1990-12-07
BRACKET, METAL, ORTHODOTNIC (K902809)Masel Industries, Inc.1990-12-07
PAROJECT ANESTHETIC SYRINGE (K904279)Ronvig Instruments, Ltd.1990-12-07
VARICOSCREEN(TM) (K900404)Promedex, Inc.1990-12-07
SYSTEM 90 AND 95 (K905293)Folio Products, Inc.1990-12-06
GORE-TEX(R) STRETCH VASCULAR GRAFT (K903931)W. L. Gore & Associates, Inc.1990-12-06
V. MUELLER TROCARS/TROCAR SLEEVES & NEEDLES (K904143)Baxter Healthcare Corp1990-12-06
SOFTSHELL VENOUS RESERVOIR (K904040)C.R. Bard, Inc.1990-12-06
TRACH-EZE (K903740)Sorex Medical1990-12-06
SHUR-LOCK ICE WRAP SYSTEM (K904819)Conco Medical Co.1990-12-06
ELEGANCE GH ELISA (K905098)Bioclone Australia Pty , Ltd.1990-12-06
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Every clearance here is in the API, with alerts when new ones post.