Atlas FDA

1989

5,030 FDA 510(k) clearances · Clearance year

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RecordFirmDate
TINY HALOGEN EXAM LIGHT (K896962)Jedmed Instrument Co.1989-12-29
EVOLUTION HIP SYSTEM (K896105)Dow Corning Wright1989-12-29
MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE (K891986)Mark One Healthcare Products1989-12-29
CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI (K895917)Coulter Immunology1989-12-29
SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN (K890349)Becton Dickinson Immunocytometry Systems1989-12-29
HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015 (K896643)Medix Biotech, Inc.1989-12-29
ORTHO* RUBELLA-G ANTIBODY ELISA TEST (K896479)Ortho Diagnostic Systems, Inc.1989-12-29
MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP (K895864)Lasag AG1989-12-29
MODEL 4000 EVOKED POTENTIAL MEASUREMENT SYSTEM (K894608)Micro-Shev , Ltd.1989-12-29
SQA (K894949)United Medical Systems, Inc.1989-12-29
MULTILUMEN CENTRAL VENOUS CATHETER (K885221)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-12-28
GRASPING FORCEPS (K896058)Annex Medical, Inc.1989-12-28
AMBULATORY INFUSION PUMP (K895426)Bionica, Inc.1989-12-27
E-Z-EM VACUUM ASPIRATION SYRINGE (K895012)E-Z-Em, Inc.1989-12-27
MODEL 6500 MERCURY ARC LIGHT SOURCE (K896008)Medical Dynamics, Inc.1989-12-27
SERENE WRAP (K895865)Byron Medical1989-12-27
CAVITY DRAINAGE CATHETERIZATION SET, CS-01600 (K895516)Arrow Intl., Inc.1989-12-27
IV DISPESNSING SPIKE (K895291)The Medi-Dose Group1989-12-27
AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE (K895465)Baxter Healthcare Corp1989-12-27
LAP SPONGE (K896801)Westmark, Sterile Packing Systems, Inc. (Sps)1989-12-27
SURGICAL SKIN MARKER (K896792)Westmark, Sterile Packing Systems, Inc. (Sps)1989-12-27
MIKRO-AQUAPURATOR (K895756)Mikro-Tek Laboratories1989-12-27
ACC.U.DIAL (K894423)Exocell, Inc.1989-12-27
MODIFIED PROLACTIN ENZYME IMMUNOASSAY TEST KIT (K896641)Medix Biotech, Inc.1989-12-27
WILSON-COOK ESOPHAGEAL PROSTHESIS (K896390)Wilson-Cook Medical, Inc.1989-12-27
STREAMLINE VASCULAR ACCESS DEVICE (K896774)Menlo Care, Inc.1989-12-27
ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY (K896145)Serono-Baker Diagnostics, Inc.1989-12-27
MAGNET PAD (K896802)Westmark, Sterile Packing Systems, Inc. (Sps)1989-12-27
LATEX EXAMINATION GLOVES (K896003)Jiea Chao Ent. Co., Ltd.1989-12-27
DIALYSIS PRIMING SETS CODES 5C4094 AND 5C4095 (K896006)Baxter Healthcare Corp1989-12-27
ALISUN SUNTANNING BED (K896831)Alisun America, Ltd.1989-12-27
FRESENIUS BIOCARB HEMODIALYSIS GRADE SODIUM BICARB (K896111)Fresenius USA, Inc.1989-12-27
NORMAL AND ABNORMAL CONTROL SERA (K895943)Sclavo, Inc.1989-12-27
CLOSED WOUND RESERVOIR (K896803)Westmark, Sterile Packing Systems, Inc. (Sps)1989-12-27
BANDAGE REMOVAL STRIP (K895884)Kut-Guard, Inc.1989-12-27
CHEMO-SPIKE RECONSTITUTION DEVICE (K895290)The Medi-Dose Group1989-12-27
LATEX EXAMINATION GLOVES (K893461)Zhum Heng Development , Ltd.1989-12-27
SUNTANNING BED, INC. T12 UVA TANNING LAMPS (K896191)Sunbronze1989-12-27
LIFEPORT VASCULAR ACCESS PORT (K895689)Strato Medical Corp.1989-12-27
CLINISTAT HDL CHOLESTEROL REAGENT TEST (K895139)Heraeus Kulzer, Inc.1989-12-27
MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP (K896589)Optik1989-12-27
ARTHROSCOPIC TUBING SHEATH (K896584)Origin Medsystems, Inc.1989-12-27
MIKRO-LAVAGE-1 (K895755)Mikro-Tek Laboratories1989-12-27
NON CONSTRAINED TOTAL SHOULDER SYSTEM (K895802)Orthopaedic Medical Group, Inc.1989-12-27
BECKMAN MA MICROALBUMIN REAGENT KIT (K895883)Beckman Instruments, Inc.1989-12-27
BECTON DICKINSON RATE INFUSER II SYSTEM (K896593)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-12-27
RAMVAC DENTAL VACUUM SYSTEM (K895876)Ramvac Corp.1989-12-26
BAUSCH & LOMB FREQUENT REPLACEMENT CASE SYSTEM (K896685)Bausch & Lomb, Inc.1989-12-26
RAMCLEAN DENTAL VACUUM LINE CLEANER (K895877)Ramvac Corp.1989-12-26
MICROTEK TOTAL OSSICULAR PROTHESIS (K895815)Microbio-Medics, Inc.1989-12-26
PLASTIC SUNGLASSES (K896716)Bright Horizon Ent.1989-12-26
MICROTEK PISTON & WIRE PROSTHESES (K895814)Microbio-Medics, Inc.1989-12-26
NON-PRESCRIPTION SUNGLASSES (K896768)Shairon Intl. Trade Co.1989-12-26
THE SMITHCOT (K896261)Ram Marketing, Inc.1989-12-22
VOSS VEIN CLAMP (K885161)Voss Medical Products1989-12-22
DU PONT XENOLITE(TM) RADIATION PROTECTION APPAREL (K896511)E.I. Dupont DE Nemours & Co., Inc.1989-12-22
ASPECT GAMMA CAMERA (K896458)Digital Scintigraphics, Inc.1989-12-22
RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM (K895849)Respironics, Inc.1989-12-22
FUJITENS III (K893874)Altoona Medical Supply1989-12-22
RADIOSCOPE OR MAMMOSCOPE (K894412)Vision Ten, Inc.1989-12-22
ACTILLUME (K894044)Ambulatory Monitoring, Inc.1989-12-22
TECA NEUROMAPPER 386 (K894889)Teca, Inc.1989-12-22
CEEGRAPH (K895125)Bio-Logic Systems Corp.1989-12-22
TISSUE OXYGEN MONITOR SYSTEM, MODEL II (K890624)Baxter Healthcare Corp1989-12-22
ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING (K895763)Healthdyne Cardiovascular, Inc.1989-12-22
KOTEX SECURITY TAMPONS (SEVERAL TYPE) (K896994)Kimberly-Clark Corp.1989-12-22
MODEL SPINE SURVEYOR-PLUS; CAT. #ACS-10A (K896336)Medical Advances, Inc.1989-12-22
STANDARD NEBULIZER HEATER (K895913)Seamless Div., Professional Medical Products1989-12-22
HEWLETT-PACKARD MODEL M1016A CO2 & M1017A FI02 (K896030)Hewlett-Packard Co.1989-12-22
SAFE-1 (K893704)Polystan C/O Vitalcor, Inc.1989-12-22
SCENTED OR SCENTED DEODORIZED, UNSCENTED TAMPONS (K897012)Playtex Family Products, Inc.1989-12-22
MODEL AO-800PA CO2 MODULE (K894691)Nihon Kohden America, Inc.1989-12-22
GE TARGET SERIES 2 (K896353)GE Medical Systems1989-12-22
AMBULATORY INFUSION SYSTEM AND ACCESSORIES (K894028)Patient Solutions, Inc.1989-12-22
SAFE-1 VENOUS RESERVOIR (K893705)Polystan C/O Vitalcor, Inc.1989-12-22
MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129) (K895555)Hichem Diagnostics1989-12-22
DISP. CONCENTRIC NEEDLE ELECTRODE (DCP-30, DCP-45) (K896370)Chalgren Enterprises, Inc.1989-12-22
V2465P X-RAY IMAGE INTENSIFIER (K896331)Hamamatsu Photonics K.K.1989-12-22
FIRST IMPRESSION TM (K894282)Coe Laboratories, Inc.1989-12-22
TAMPAX TAMPON (K896989)Tambrands, Inc.1989-12-22
TOOTH SHADE RESIN (K895976)G-C Intl. Corp.1989-12-22
ORIGINAL TICK KIT/1ST AID KIT (K895767)Tick Kit, Inc.1989-12-22
SECHRIST DISPOSABLE INFANT BREATHING CIRCUIT (K895853)Sechrist Industries, Inc.1989-12-22
PLATELIA RUBELLA IGG KIT (K894946)Kallestad Diag, A Div. of Erbamont, Inc.1989-12-21
WILTEK BALLOON STONE EXTRACTOR (K894865)Wiltek Medical, Inc.1989-12-21
WILTEK POLYPECTOMY SNARE (K894869)Wiltek Medical, Inc.1989-12-21
PATIENT EXAMINATION GLOVES (LATEX) (K892633)Gobo Intl.1989-12-21
ISODENT (K894058)Eurodent, Inc.1989-12-21
SILCOT COPAL CAVITY VARNISH (K895798)Specialites Septodont1989-12-21
HEMA-PRIMER (K895750)Parkell1989-12-21
MODEL 4070 TEMPERATURE MONITOR (K895875)Mallinckrodt Anesthesia Products1989-12-21
WILTEK GASTRIC FEEDING TUBE (K894860)Wiltek Medical, Inc.1989-12-21
WILTEK STONE EXTRACTOR (K894866)Wiltek Medical, Inc.1989-12-21
WILTEK NASAL BILIARY DRAINAGE SET (K894870)Wiltek Medical, Inc.1989-12-21
BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS (K895748)Catachem, Inc.1989-12-21
NO. 87500-NUPORT PEG GASTROSTOMY TUBE KIT 22 FR (K894653)Superior Biosystems, Inc.1989-12-21
PATIENT EXAMINATION GLOVES (K893632)Pro Asia, Inc.1989-12-21
WILTEK E.R.C.P. CATHETER (K894867)Wiltek Medical, Inc.1989-12-21
LATEX PATIENT EXAMINATION GLOVES (K895754)Frontline Latex Products Pvt. , Ltd.1989-12-21
ARTECH TYPE SS SUBMERGED SCREW IMPLANT (K891346)Artech Corp.1989-12-21
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Track 1989 automatically

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