Atlas FDA

1992

3,665 FDA 510(k) clearances · Clearance year

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RecordFirmDate
LYPHOCHEK(R) FRUCTOSAMINE CONTROL (K921089)Bio-Rad1992-04-29
REDDICK RETRACTOR (K915175)Ideal Medical, Inc.1992-04-29
VACUTAINER(R) BRAND SAFETY-LOK BLOOD COLLECT SET (K921636)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-04-29
HALOCATH LASER CATHETERS (K920934)Trimedyne, Inc.1992-04-29
SYSMEX HEMATOLOGY SYSTEM ACCESSORIES (K920544)Toa Medical Electronics USA, Inc.1992-04-29
MICRO-COLL COLLAGEN DERMAL WOUND SPRAY (K920642)Micro-Collagen Pharmaceutics, Ltd.1992-04-29
RADIUS OSTEOTOMY PLATES (K914804)Link America, Inc.1992-04-29
10% PHOSPHORIC ACID ETCHING GEL (K920483)Pulpdent Corp.1992-04-29
HCG CONTROL (K921206)Polymedco, Inc.1992-04-29
PACER DISPOSABLE YANKAUER SUCTION INSTRUMENT (K921095)Pacer Tool & Plastics, Inc.1992-04-29
FORTRESS 1800FS REAR WHEEL DRIVE SCOOTER (K921069)Fortress Scientific , Ltd.1992-04-29
RIFTON MOR219 19 & RIFTON MOR225 25 (K921817)Rifton Equipment For the Handicapped1992-04-29
ANGLED DELIVERY DEVICE (K920589)Laserscope1992-04-29
AUQASOOTHE/AQUA MED (K915729)Aquasoothe1992-04-29
CORRECTED-V.P.S. (K914178)Jeneric/Pentron, Inc.1992-04-28
PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH (K915358)Medtronic Vascular1992-04-28
EPISCOPE, MODEL 47300 (K920103)Welch Allyn, Inc.1992-04-28
PHOENIX STERI-TECH STERILE DENTAL PACK GEN-10001 (K920682)Phoenix Steri-Tech, Inc.1992-04-28
RIONET HEARING AID HB-52T (K921830)Authorized Hearing Systems, Inc.1992-04-28
GX-C CEPHALOMETER (K920189)Gendex Corp.1992-04-28
THERAPEUTIC STIMULATOR 2100 (TS-2100) (K914904)Myo/Kinetic Systems, Inc.1992-04-28
MRT-50 MULTIVIEW COIL (K920095)Toshiba America Mri, Inc.1992-04-28
DECOMPRESSION TUBES (K920894)Applied Medical Technologies1992-04-28
14% HYDROFLUORIC ACID ETCHING GEL (K920482)Pulpdent Corp.1992-04-28
SILICONT BUR BLOCK (K921406)Innovators, Inc.1992-04-28
MORTARA INSTRUMENT MODEL ECG PREVU (K920377)Mortara Instrument, Inc.1992-04-28
ENZYGNOST(R) ANTI-CMV IGG (K913910)Behring Diagnostics, Inc.1992-04-28
ELECTROSURGICAL GENERATOR MODEL ESU100/250/550 (K914367)Gyne-Tech Instrument Corp.1992-04-28
JENKER NEEDLE STICK PROTECTOR (K920758)Dentsply Intl.1992-04-28
PH METER, MODIFICATION (K914624)Synectics-Dantec1992-04-28
4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL (K920460)Pulpdent Corp.1992-04-28
SCHWABE RADIUS PLATES (K914803)Link America, Inc.1992-04-28
TRUE/FLEX HUMERUS CAP (K920598)Applied Osteo Systems, Inc.1992-04-28
K3 COMPUTER SYSTEMS (K902977)Donald L. King M.D.1992-04-28
2.5% NITRIC ACID ETCHING GEL (K920484)Pulpdent Corp.1992-04-28
ESCORT-LINK ARRHYTHMIA OPTION 23L (K915153)Medical Data Electronics1992-04-27
POLYTRON DIGITAL IMAGING SYSTEM (K920705)Siemens Medical Solutions USA, Inc.1992-04-27
BARD 4-WIRE URETEROSCOPIC STONE (K921233)C.R. Bard, Inc.1992-04-27
PHILIPS EASYVISION (K920950)Philips Medical Systems, Inc.1992-04-27
HIGH SPEED ROTATION STARTER SA-50 (K920724)Shimadzu Medical Systems1992-04-27
ECAT EXACT HR MODEL 961 (K920624)Cti Pet Systems, Inc.1992-04-27
KODAK X-OMAT FIXER MANAGER (K920715)Eastman Kodak Company1992-04-27
BUCKY TABLE BK-12 (K920729)Shimadzu Medical Systems1992-04-27
X-RAY HIGH VOLTAGE GENERATOR ED 125L (K920730)Shimadzu Medical Systems1992-04-27
VECTOR SERIES (K921008)Sopha Medical Systems, Inc.1992-04-27
LOMEFLOXACIN, 10 MCG, SENSI DISC (K921193)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-04-27
QCC CUSTOM CANAL AND QE1 ALL ITE (K920911)Qualitech Electronics, Inc.1992-04-27
HIGH SPEED ROTATION STARTER SA-40 (K920723)Shimadzu Medical Systems1992-04-27
HYDRAJUST IV UROLOGICAL TABLE (K920742)Mallinckrodt Group, Inc.1992-04-27
SONO-VU US(TM), MODIFICATION (K921738)E-Z-Em, Inc.1992-04-27
CARDIAC TRIAD NUCLEAR IMAGING SYSTEM (K920776)Trionix Research Laboratory, Inc.1992-04-27
ACCUSCOPE(TM) & ACCUSCOPE II(TM) (K913365)Vineland Medical Products, Inc.1992-04-27
COROMETRICS MODEL 150 FETAL MONITOR (K920376)Ge Medical Systems Information Technologies1992-04-27
PRESSURE GAUGE (K921026)Hobbs Medical, Inc.1992-04-24
IL TEST METHADONE (K920858)Instrumentation Laboratory CO1992-04-24
DISPOSABLE ASPIRATION IRRIGATION SYSTEM (K912093)Applied Urology, Inc.1992-04-24
INTRALUMINAL ARTERY STRIPPER (K913803)Omni-Tract Surgical, Div. Minn. Scientific, Inc.1992-04-24
SLEEPMASTER (K911386)Biomedical Monitoring Systems, Inc.1992-04-24
IL TEST BARBITURATE, 35289 (K920417)Instrumentation Laboratory CO1992-04-24
URETEROMAT 4400 (K915751)F.M. Wiest USA, Inc.1992-04-24
OPTIEAR (K920322)Nankivell Industries, Inc.1992-04-23
BACT/ALERT PEDI-BACT (K920249)Organon Teknika Corp.1992-04-23
LACERATION TRAYS (K920341)Medikmark, Inc.1992-04-23
HAYEK OSCILLATOR, MODIFICATION (K921726)Respironics, Inc.1992-04-23
SIEMENS RADIOTOM 904 & 904E ELECTROSURGERY UNIT (K912070)Siemens Medical Electronics1992-04-23
DRESSING CHANGE TRAY (K920339)Medikmark, Inc.1992-04-23
AUGUSTINE GUIDE KIT (K921166)Augustine Medical, Inc.1992-04-23
SUTURE REMOVAL KIT (K920340)Medikmark, Inc.1992-04-23
AMETEC MASY MODULAR ANGIOSCOPE SYSTEM (K905745)American Medical Technology, Inc.1992-04-23
CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET (K914936)Akcess Medical Products, Inc.1992-04-23
AUGUSTINE STYLET (K920468)Augustine Medical, Inc.1992-04-23
BTM-100 POWERED MUSCLE STIMULATOR (PROPOSED) (K914999)Bt Medical Co., Inc.1992-04-23
RUBELLA IGM ELISA TEST SYSTEM (K914028)Zeus Scientific, Inc.1992-04-22
BACTEC 9240 SYSTEM (K915796)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-04-22
RIGHT ATRIAL CATHETER KITS (K920331)Akcess Medical Products, Inc.1992-04-22
NIACIN CONTROL DISKS (K920257)Remel Co.1992-04-22
BACTEC PLUS AEROBIC/F AND ANAEROBIC/F MEDIA (K921133)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-04-22
ORTHO HSV ANTIGEN ELISA TEST (K915551)Ortho Diagnostic Systems, Inc.1992-04-22
PERRY(R) NATURAL POWDER-FREE GLOVES, STYLE 45 (K914445)Smith & Nephew Perry1992-04-22
SLT SPECTRA (K915689)Slt Labinstruments, Inc.1992-04-22
EZ GAUZE SPONGE (K920269)Cal West Trading Co.1992-04-22
MYDAS(TM)-MB2/MYDAS(TM)-MB (K913380)Intl. Immunoassay Laboratories, Inc.1992-04-22
REGULATOR FLOWMETER (K915505)Lifeguard Medical Products, Inc.1992-04-22
EASY TOUCH LATEX EAM GLOVES (K920174)Simpex, Inc.1992-04-22
MODIFICATION PROSPECT GIARDIA RAPID ASSAY (K920817)Alexon, Inc.1992-04-22
ALBICANS SURE (K913426)Jrga Diagnostics1992-04-22
SLT 340 ATTC (K915690)Slt Labinstruments, Inc.1992-04-22
NEEDLEGARD II (K920717)Ingenious Technologies Corp.1992-04-22
BACTERIA FILTER (K912577)Vital Signs, Inc.1992-04-22
FEMOSTOP (K915280)Radi Medical Systems AB1992-04-22
FETAL DOPPLER (K905536)Toshiba America Medical Systems, In.C1992-04-21
DEROYAL HYDROGEL DRESSING (K915182)Deroyal Industries, Inc.1992-04-21
DEPUY TOTAL HIP BALLS - ION IMPLANTATION (K920286)Depuy, Inc.1992-04-21
WEINSTEIN CORNEAL MIRCOAESTHESIOMETER (K920271)Connecticut Bioinstruments, Inc.1992-04-21
WIL-PDS & WIL-PDI CASTING ALLOYS (K915250)Wilde-USA, Inc.1992-04-21
PERCUGUIDE LESION MARKING (K920816)E-Z-Em, Inc.1992-04-21
MODEL RD-1200 RUBY LASER SYSTEM (K910422)Spectrum Medical Technologies, Inc.1992-04-21
SEPTOCALCINE ULTRA (K920692)Specialites Septodont1992-04-21
SUNGLASSES (K920344)J & D Products, Inc.1992-04-21
HOLLOW SCREW IMPLANTS 6MM, 14MM, 16MM (K920768)The Straumann Co.1992-04-21
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Every clearance here is in the API, with alerts when new ones post.