Atlas FDA

1986

4,347 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MASUNAGA OPTICAL MANUFACTURING (K862502)South West Intl., Inc.1986-07-11
REFLOTRON URIC ACID (K861831)Boehringer Mannheim Corp.1986-07-11
RITCH TRABECULOPLASTY LASER LENS (K862512)Ocular Instruments, Inc.1986-07-11
KOELN OPTIK (K862503)South West Intl., Inc.1986-07-11
KIRSCHNER UNIVERSAL BIPOLAR ENDOPROSTHETIC HEAD (K862057)Kirschner Medical Corp.1986-07-11
PRECEPT CEFTAZIDIME (K862446)Austin Biological Laboratories1986-07-11
DIGITAL ELECTRONIC MYO-GRAPH (MUSCLE ANALYZER) (K862128)Health Products, Inc.1986-07-11
BAUSCH & LOMB GR-3 REFRACTOR (K862521)Bausch & Lomb, Inc.1986-07-11
ENDOTRACHEAL TUBE, ACCESSORY (K862347)Sheridan Catheter Corp.1986-07-11
PRECEPT CEFTIZOXIME (K862560)Austin Biological Laboratories1986-07-11
BAUSCH & LOMB PSL-3000 SLIT LAMP (K862520)Bausch & Lomb, Inc.1986-07-11
INTERNATIONAL TOTAL HIP SYSTEM (K862225)Richards Medical Co., Inc.1986-07-11
CANDI-KIT TM (K854672)Culture Kits, Inc.1986-07-11
KODAK M35A X-OMAT PROCESSOR (K862595)Eastman Kodak Company1986-07-11
SNAP-ON TORQUER (K862409)Advanced Cardiovascular Systems, Inc.1986-07-11
SERIES TEN THOUSAND MASTER (K861380)CooperVision, Inc.1986-07-11
SENTEC LASER GUIDE LINE, MODEL SGL-05 (K862340)Sentec Corp.1986-07-11
SERIES TEN THOUSAND COMPACT (K861565)CooperVision, Inc.1986-07-11
DELFIA (TM) HCG KIT (K862044)Lkb Instruments, Inc.1986-07-11
SENTRY BREAKWAY NECK STRAP (K862538)Ormco Corp.1986-07-11
EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95 (K862403)Diagnostic Systems1986-07-11
VACUUM HANDLE MODEL I/A - 1 (K862343)Cutler Medical Instruments1986-07-11
ALTERNATE SIZE E-Z-PACE ELECTRODE (K862298)Medtronic Vascular1986-07-11
APLICARE SKIN PROTECTANT PREP PAD (K861557)Aplicare, Inc.1986-07-11
DELFIA DIGOXIN (K861195)Lkb Instruments, Inc.1986-07-11
BAUSCH & LOMB CSL-1000 SLIT LAMP (K862515)Bausch & Lomb, Inc.1986-07-11
TORAY SUPERSELECTIVE GUIDEWIRE,SUPERSELEC Y-K TYPE (K861115)Toray Industries (America), Inc.1986-07-11
BAUSCH & LOMB OSL-2000 SLIT LAMP (K862516)Bausch & Lomb, Inc.1986-07-11
MICROTEK STAINLESS STEEL PISTON (K860460)Microtek Medical, Inc.1986-07-11
CURITY CENTRAL VENOUS CATHETERIZATION TRAY (K861827)The Kendal Co.1986-07-11
OPM SLIT LAMP MODEL P-1 (K861854)Optek Medico Co., Ltd.1986-07-11
SUSSMAN FOUR MIRROR HAND HELD GONIOPRISM (K862024)Ocular Instruments, Inc.1986-07-11
ADVANCED PERFORM HOLLOW FIBER DIALYZER, 01-9751-7 (K861536)National Medical Care, Medical Products Div., Inc.1986-07-10
MODEL 431-02 BIOPORE IMPLANTABLE PACING LEAD (K862257)Intermedics, Inc.1986-07-10
ADVANCED PERFORMANCE HOLLOW FIBER DIALYZER (K861916)National Medical Care, Medical Products Div., Inc.1986-07-10
RICH-MAR RM 2002 ULTRASOUND PHYSICAL THERAPY DEVIC (K862469)Rich-Mar Corp.1986-07-10
FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR (K862318)Fisher Scientific Co., LLC1986-07-10
MAKS CENTRAL DELIVERY SYSTEMS MODELS 11-425/11-445 (K861472)National Medical Care, Medical Products Div., Inc.1986-07-10
MEDTRONIC TEMPORARY AND IMPLANTABLE PACING LEADS (K862443)Medtronic Vascular1986-07-10
V-MARC 88A COMPUTER (K862089)V.Marc, A Div. of Pictorial, Inc.1986-07-10
COTTON FILLED GAUZE SPONGES 2 X 2 (K861727)Cross Country Paper Products Corp.1986-07-10
SUCTION T CONNECTOR (K862434)Acutronic Medical Systems AG1986-07-10
ADVANCED PERFORM HOLLOW FIBER DIALYZER, 019752-5 (K861537)National Medical Care, Medical Products Div., Inc.1986-07-10
RICH-MAR RM-2000 ULTRASOUND PHYSICAL THERAPY DEVIC (K862468)Rich-Mar Corp.1986-07-10
HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA) (K862555)Viromed Laboratories, Inc.1986-07-10
MODEL 437-01 BIOPORE IMPLANTABLE PACING LEAD (K862258)Intermedics, Inc.1986-07-10
515A NEO-TRAK NEONATAL MONITOR (K861861)Ge Medical Systems Information Technologies1986-07-10
ARF-1500 CONTINUOUS VENTILATOR (K860798)Medimex, Inc.1986-07-10
ACS CORONARY GUIDING CATHETER (K861236)Advanced Cardiovascular Systems, Inc.1986-07-10
MODEL 433-01 BIOPORE IMPLANTABLE PACING LEAD (K862259)Intermedics, Inc.1986-07-10
MASTER KIT B (K861142)Pro-Lab, Inc.1986-07-10
CURITY CENTRAL VENOUS CATHETER (K861829)The Kendal Co.1986-07-10
CURITY VENOUS CATHETERIZATION KIT (K861828)The Kendal Co.1986-07-10
INTERSTIM 100 SYSTEM (K861136)Buckman Co., Inc.1986-07-09
# 10099/10225/10235/10275/10525/10625/10715/10125 (K862193)U.O. Equipment Co.1986-07-09
TANNING SOFA (K862341)Hardwood Design Shop1986-07-09
ULTRATAN TANNING SYSTEM (K862372)Health Systems Intl., Inc.1986-07-09
FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01 (K862072)International Biomedics, Inc.1986-07-09
THE RELAXARE EXERCISE AND MASSAGE UNIT (K862411)Relaxare Corp.1986-07-09
JOHNSON & JOHNSON PETROLATUM GAUZE NON ADHER DRESS (K862163)Johnson & Johnson Professionals, Inc.1986-07-09
TAMPAX TAMPONS, VARIOUS SIZES/TYPES (MODIFICATION) (K862353)Tambrands, Inc.1986-07-09
ARISE, VIVRE DEBOUT (K862305)Natco Corp.1986-07-09
AIR-CUSHION TOCOTONOMETER (K860933)International Biomedics, Inc.1986-07-09
RESTOR (COMET)*DENTAL RESTORATIVE (K861833)Johnson & Johnson Professionals, Inc.1986-07-09
HUNTLEIGH DOPCORD, D140 (K854267)Huntleigh Technology, Inc.1986-07-09
MODEL UST-SSD 880L1-5 TRANESOPHAGEAL PHASED ARRAY (K861710)Johnson & Johnson Professionals, Inc.1986-07-09
MEDSURG CUSTOM DRESSING TRAYS (K861693)Medsurg Industries, Inc.1986-07-08
HOWMEDICA HOFFMANN FIXATION PIN SYSTEM (K861766)Howmedica Corp.1986-07-08
ARMBOARDS, REUSABLE AND DISPOSABLE (K862111)Abco Dealers, Inc.1986-07-08
WARSAW ORTHOPEDIC BONE PLATE (K862254)Warsaw Orthopedic, Inc.1986-07-08
CATALOG NO. I/A 100 AND KPE 200 (K862334)Ipax, Inc.1986-07-08
GHI WET PENCIL (K861614)Surgical Products Corp.1986-07-08
PRO-CLEAN (K862367)Dermacare Products, Inc.1986-07-08
T.P.N. DRESSING CHANGE TRAY (K862219)Welmed Systems, Inc.1986-07-08
KOTEX LIGHTDAYS DEODORANT PANTILINERS (K862285)Kimberly-Clark Corp.1986-07-08
KING DIAGNOSTICS URIC ACID TEST (K862208)King Diagnostics, Inc.1986-07-08
(MT-27) THERMOMETER AND (M-10PC) PROBE COVERS (K862333)Sharp Electronics Corp.1986-07-08
CW DOPPLER STATIC TRANSDUCERS (K861109)Advanced Technology Laboratories, Inc.1986-07-08
ORTHOBLEND POWERED BONE MILL (K860356)Zimmer, Inc.1986-07-08
STANDING WHEELER (K862013)Engineering Mechanics, Co.1986-07-08
ADCOMP (K860610)Healthtek, Inc.1986-07-08
EASY-TEST EMIT* THEOPHYLLINE(THEO) ITEM 67533/93 (K862350)Em Diagnostic Systems, Inc.1986-07-07
MODEL 545-45 LASER FOR DERMA., POD., SURGICAL (K860974)Britt Corp., Inc.1986-07-07
TDX REA LACTIC ACID (K861741)Abbott Laboratories1986-07-07
VANILMANDELIC ACID (VMA) REAGENT SET (K861962)Sterling Diagnostics, Inc.1986-07-07
V-TREND QC URINE CHEMISTRY CONTROLS LEVEL, I & II (K861756)Texas Immunology, Inc.1986-07-07
RESUSCITATOR MODELS 10400/10500/10600/10700/10800 (K862192)U.O. Equipment Co.1986-07-07
LAURIER SAFETY LONG SANITARY NAPKIN (MODIFICATION) (K862271)Kao Corp.1986-07-07
CHLAMYDIA KIT, STD KIT (K862322)Intl. Cytobrush, Inc.1986-07-07
EASY-TEST (TM) EMIT* PHENOBARBITAL (PHNO)/67534/93 (K862308)Em Diagnostic Systems, Inc.1986-07-07
5.0 MHZ INTRAOPERATIVE ARRAY (K860123)Siemens Medical Solutions USA, Inc.1986-07-07
ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM (K861773)Zygotek Systems, Inc.1986-07-07
NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE (K862365)Swemed Laboratories, Inc.1986-07-07
HBDH (OPTIMIZED) REAGENT (K862319)Sigma Chemical Co.1986-07-07
CIRCUIT ANES. BREATHING & COMPONENTS (K862003)Vital Signs, Inc.1986-07-07
ULTRAMED TF 122 ULTRASON VASCU IMAG & DOPPLER SYST (K861378)Ultramed, Inc.1986-07-07
LAURIER OVERNIGHT SANITARY NAPKIN (MODIFICATION) (K862270)Kao Corp.1986-07-07
MODIFIED FETAL MONITOR MODEL FM-2 (K861556)Advantage Medical Systems, Inc.1986-07-07
DIRECT ACU-SLIDE TEST (K861212)Cal-Tech Diagnostics, Inc.1986-07-07
MODIFIED COTROPIN RADIOIMMUNOASSAY KIT (K862180)Clinetics Corp.1986-07-07
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Every clearance here is in the API, with alerts when new ones post.