Atlas FDA

1985

4,483 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SUNGLASSES/OPTICAL FRAMES (K854264)Wha Chun Industries, Co., Ltd.1985-11-12
FOX BED MODEL 2001 (K854154)Ace Mfg.1985-11-08
OE SERIES OF BEHIND-THE-EAR HEARING AIDS (K853381)Emtech Laboratories1985-11-08
I.S.M. PRODUCT FAMILY MODEL R3600C (K854170)Intl. Solarium Manufacturer, Inc.1985-11-08
SUPRIMA MODEL 254-22 (K852339)Intermedics, Inc.1985-11-08
SUPRIMA MODEL 254-24 (K852340)Intermedics, Inc.1985-11-08
ALPHA CHUCK (K853970)Rocky Mountain Medical Corp.1985-11-08
DIGITAL THERMOMETER (K853824)Epson America, Inc.1985-11-08
ULTRAVIOLET TREATMENT LAMPS UV-8 & UV-9 (K852534)R. A. Fischer Co. Corp.1985-11-08
EXPRESS TAN SUN CANOPY (K854111)Sunmaker Tanning Systems, Ltd.1985-11-08
INTEGRATED DISPLAY TECHNOLOGY LTD. (K853130)Integrated Display Technology, Ltd.1985-11-08
MICROTHERM MT-501 & MT-502 (K854007)Medequi, Division of King Yip Co., Inc.1985-11-08
TOSHIBA TCT-900S COMPUTED TOMOGRAPHY CT X-RAY SYS (K853444)Toshiba Medical Systems1985-11-08
CHURCHILL 3-WAY STOPCOCK SET (K854348)Churchill Corp.1985-11-08
CARDIO METRICS INVASIVE PRESSURE MONIT (K841960)Sterile Design, Inc.1985-11-08
PCX-100 PATIENT INPUT LEADWIRE (K851632)Eaton Medical Group1985-11-08
PEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENT (K854084)Organon Teknika Corp.1985-11-08
NEO SHIELD (K852943)Gaymar Industries, Inc.1985-11-08
PHASE V-MODEL 1500 RUVA (K854131)Apollo'S Suntanning Supplies1985-11-08
GOLDEN RULE SUN TANNING BEDS (K854224)Golden Rule Tanning Co., Inc.1985-11-08
KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTR (K851627)Eaton Medical Group1985-11-08
ECHO TYPE 16 CF ANTIGEN (K853156)Hillcrest Biologicals1985-11-07
THE VICKERS STANDARD MICROSURGERY SET (K853161)Keeler Instruments, Inc.1985-11-07
MEDIPART DISPOS. XENON 133 ADMIN. SET MP-0133M (K853576)Medipart Jerry Alexander1985-11-07
MEDIPART CORRUGATED POLYETHYLENE & E.V.A. TUBING (K853569)Medipart Jerry Alexander1985-11-07
ECHO TYPE 30 CF ANTIGEN (K853165)Hillcrest Biologicals1985-11-07
MEDIPART DISPOS. XENON 133 ADMIN. SYS MP-0133 (K853579)Medipart Jerry Alexander1985-11-07
COXSACKIE A2 CF ANTIGEN, A4, A10 & A16 (K853279)Hillcrest Biologicals1985-11-07
VICKERS ERGOMATIC MICROSUR INSTRU-UNIV R O L HAND (K853179)Keeler Instruments, Inc.1985-11-07
MES-TENS(TENS) (K853416)Oriental Medical Supplies, Inc.1985-11-07
POLIO TYPE I CF ANTIGEN, & TYPE II, III (K853278)Hillcrest Biologicals1985-11-07
UNITRON MODEL UM60-PP (K853781)Unitron Industries, Inc.1985-11-07
VISIBLE LIGHT CURED ORTHODONTIC ADHESIVE (K853523)Dentsply Intl.1985-11-07
GOLDEN CERAMIC (K853982)Wiliams Gold Refining Co., Inc.1985-11-07
RESIN TRAY IMPRESSION MATERIAL (K854042)Dentsply Intl.1985-11-07
CMV CF ANTIGEN (K853277)Hillcrest Biologicals1985-11-07
ECHO TYPE 11 CF ANTIGEN (K853157)Hillcrest Biologicals1985-11-07
PALL PULMONARY FUNCTION FILTER (K854062)Pall Biomedical Products Co.1985-11-07
HEARING AID(ALL IN EAR) (K852244)Olympia Instruments, Inc.1985-11-07
MEDIPART DRIERITE MP-1002 (K853570)Medipart Jerry Alexander1985-11-07
UNITRON MODEL UM60-D (K853780)Unitron Industries, Inc.1985-11-07
BELIEVE HEAVY FLOW PROTECTION LABIAL PADS (K853630)Kimberly-Clark Corp.1985-11-07
ALLERG-E IGE ENZYME IMMUNOASSAY KIT (K853607)Dexall Biomedical Labs, Inc.1985-11-07
SLIDING RECONSTITUTION DEVICE W/ADMIX VIALEX PLAST (K853830)Travenol Laboratories, S.A.1985-11-06
SNAP-LOCK ADDITIVE CAP #SL100 (K854031)Williams Medical Co.1985-11-06
DRAKE WILLOCK 480 UF CONTROL IDALYSATE DELIVERY SY (K853513)Cd Medical, Inc.1985-11-06
SNAP-LOCK ADDITIVE CAP #SL400 (K854033)Williams Medical Co.1985-11-06
NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8 (K853134)Erika, Inc.1985-11-06
MEDTRONIC ACCESS PORT MODEL 8500 (K853322)Medtronic Vascular1985-11-06
MVM 4000 HOLTER IV RECORDER (K853985)Mountain View Medical1985-11-06
GUIDING CATHETER (K853998)Target Therapeutics1985-11-06
I.S.M. PRODUCT FAMILY MODEL P2400C,A & ABC (K854171)Intl. Solarium Manufacturer, Inc.1985-11-06
NOVAMETRIX PULSE OXIMETER, MODEL 500 (K853124)Novametrix Medical Systems, Inc.1985-11-06
LAP-CATH (K852197)Research Medical, Inc.1985-11-06
SNAP-LOCK ADDITIVE CAP #SL 300 (K854034)Williams Medical Co.1985-11-06
DEMAND ETHYL ALCOHOL (K854130)Cooper Biomedical, Inc.1985-11-05
URI-CATH SYSTEM (K852490)Gesco Intl., Inc.1985-11-05
SETMA VHT (K853163)Setma, Inc.1985-11-05
HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY (K853239)Haemachem, Inc.1985-11-05
GUIDE WIRE (K853999)Target Therapeutics1985-11-05
SUR-FIT FACE MASK (K854161)Anesthesia Respiratory Technology, Inc.1985-11-05
CORPAK FARRELL VALVE ENTERAL GASTRIC PRESSURE RELI (K853253)Corpak Co.1985-11-05
EMERGIPACE - EXTERNAL PACEMAKER (K850812)Life Science Instrumentation, Inc.1985-11-05
CR 280/45, CR281/4 DEFIBRILLATOR (K852905)Cardiac Recorders, Ltd.1985-11-05
INFUSION CATHETER W/SIDE HOLES (K854000)Target Therapeutics1985-11-05
COULTER COUNTER MODEL T-660 (K854114)Coulter Electronics, Inc.1985-11-05
FLEXISTAND MAJOR (K852152)Zygotek Assoc.1985-11-05
TDX COCAINE METABOLITE (K854163)Abbott Laboratories1985-11-05
MULTIPLE (K853297)Sun Air, Inc.1985-11-05
THE MOVER (K853424)Invacare Corp.1985-11-05
INFUSION CATHETER (K853997)Target Therapeutics1985-11-05
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE HB (K854139)Eastman Kodak Company1985-11-05
E-Z-EM GASTRIC LAVAGE CATHETER (K853384)E-Z-Em, Inc.1985-11-05
KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS (K853328)Ortho Diagnostic Systems, Inc.1985-11-05
COMFORT + LIFT (K852812)Invacare Corp.1985-11-05
7 FRENCH DUAL LUMEN COM CENT VEIN CATH SYS (K852791)Cardio-Vascular Innovations, Inc.1985-11-05
COMPAS 1 (K853209)Cardiac Care Units, Inc.1985-11-05
POWER DRIVE WHEELCHAIR (K853649)Everest & Jennings, Inc.1985-11-05
ROTACLONE ROTAVIRUS DIAGNOSTIC KIT (K852969)Cambridge Bioscience Corp.1985-11-05
LIFELINE ENDOCARDIAL BIPOLAR LEAD 476-06 (K853518)Intermedics, Inc.1985-11-05
ASA BLOOD TUBING LINES (K854271)Organon Teknika Corp.1985-11-05
ENDODYNAMICS SIEGEL THERAPUTIC STENT (K853666)E-Z-Em, Inc.1985-11-05
TDX PHENCYCLIDINE (K854167)Abbott Laboratories1985-11-05
ENZYGNOST ANTIHERPES SIMPLEX VIRUS (K841245)Behring Diagnostics, Inc.1985-11-05
TECHNICON RA SYSTEMS FOR TRIGLYCERIDES ANALYSIS IN (K854152)Technicon Instruments Corp.1985-11-05
COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE (K851153)Astral Medical Systems1985-11-05
RENALFO HEMOFILTER CAVHD (K854011)Renal Systems, Inc.1985-11-05
PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1 (K853036)Diagnostic Technology, Inc.1985-11-05
OPHTHALMIC KNIFE W/REMOVALE DEPTH GUIDE (K853598)Myocure, Inc.1985-11-04
VERSABLADE (K852706)Alphamedix, Inc.1985-11-04
BEAVER R-K KNIFE (K852828)Rudolph Beaver, Inc.1985-11-04
88000 GASTROSTOMY-JEJUNAL FEEDING TUBE KIT (K853353)Superior Healthcare Group, Inc.1985-11-04
STORZ DIAMOND KNIFE (K853403)Storz Instrument Co.1985-11-04
UCD URINE SPECIMEN COLLECTOR (K854173)Baker Instructions Corp.1985-11-04
SMARTKNIFE SYSTEM (K853063)CooperVision, Inc.1985-11-04
VERSABLADE (K852633)Alphamedix, Inc.1985-11-04
ENDODYNAMIC SIEGEL SPHINCTEROTOME (K853680)E-Z-Em, Inc.1985-11-04
FIRST TEMP (K853713)Intelligent Medical Systems1985-11-01
PORTA-POLE TM MEDICAL EQUIPMENT POLE W/FOLD (K854082)Gray Wave Corp.1985-11-01
ANTISERUM TO HUMAN APOLIPOPROTEIN B (K850690)Kent Laboratories, Inc.1985-11-01
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Every clearance here is in the API, with alerts when new ones post.