Atlas FDA

1986

536 FDA 510(k) clearances · PMA decision year

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◉ Watch 1986

RecordFirmDate
FLEX-CARE II (N18143/S029)Alcon Laboratories1986-08-27
DORNIER LITHOTRIPTER, MODEL HM3 (P840008/S005)Dornier Medtech America, Inc.1986-08-27
AB-CORE K HEPATITIS B CORE ANTIGEN 125I (P850044/S001)Sorin Biomedica, Fiat, USA, Inc.1986-08-26
PLIAGEL CLEANING SOLUTION FOR HYDROPHILIC(SOFT) CO (P800026/S002)Alcon Laboratories1986-08-26
CLERZ LUBRICATING & REWETTING EYE DROPS (P800034/S005)Alcon Laboratories1986-08-26
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S023)Advanced Cardiovascular Systems, Inc.1986-08-25
GAMMA DAB (125I) AFP RIA KIT (P790032/S001)Incstar Corp.1986-08-22
LAMICEL(TM) (P820075/S002)Medtronic Xomed, Inc.1986-08-22
CORDIS PROGRAMMABLE NEURAL STIMULATOR MODELS 900A, (P800040/S008)Cordis Corp.1986-08-20
HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE (P850010/S002)Integra LifeSciences Corporation1986-08-18
HYDROCURVE (N17752/S021)Ciba Vision Corporation1986-08-13
EYERISOL(R) (P810034/S003)Bionomics Intl., Inc.1986-08-11
BOSTON LENS(R) LENS - CLEAR (P820065/S021)Polymer Technology Corp.1986-08-11
OCUSIL(TM) CONTACT LENS (P840050/S006)O.S.I. Corp.1986-08-11
NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S010)Coherent Medical Division1986-08-11
STYLE UV40 POSTERIOR CHAMBER LENS (P830056/S011)Carl Zeiss Meditec, AG1986-08-08
DIASONICS NMR IMAGING SYSTEM (P830053/S019)Diasonics, Inc.1986-08-08
OPTACRYL 60 - CLEAR (P820056/S003)Paragon Vision Sciences1986-08-07
SOFTACT II (POLYMACON) (P830006/S003)Premier Contact Lens1986-08-07
DURASOFT(R) 3 FOR EXT WEAR (P830037/S007)Alcon Laboratories, Inc.1986-08-07
SENSITIVE EYES(TM) SALINE SOLUTION (P810039/S012)Bausch & Lomb, Inc.1986-08-07
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S006)Philips Medical Systems (Cleveland), Inc.1986-08-07
INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4 (P800036/S008)Intera Oncology1986-08-06
GORE-TEX(R) EXPANDED PTFE SUTURE (P820083/S004)W. L. Gore & Associates, Inc.1986-08-05
SUPRAMID EXTRA SUTURES (N80838/S010)S. Jackson, Inc.1986-08-05
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S005)General Electric Co.1986-08-04
SAUFLON(R) PW (LIDOFILCON B) (P790020/S034)Advanced Medical Optics, Inc.1986-08-04
PERMATINT(R) (P820059/S010)Wesley Jessen Corp.1986-08-04
OPTACRYL 60 - CLEAR (P820056/S018)Paragon Vision Sciences1986-08-04
MINITHEERM (N18001/S009)Ciba Vision Care1986-08-04
CMW BONE CEMENT (N18466/S005)Depuy, Inc.1986-08-01
KELMAN(TM) OMNIFIT II MODEL 2100 (P850059)Bausch & Lomb Surgical, Inc.1986-07-31
SOFLENS (N16895/S041)Bausch & Lomb, Inc.1986-07-31
SOFLENS(R) ENZYMATIC CONTACT LENS CLEANER (N17654/S016)Advanced Medical Optics, Inc.1986-07-31
DDD PULSE GENERATOR 674 (P840014)Pacesetter Systems1986-07-31
BOSTON LENS(R) LENS - CLEAR (P820065/S035)Polymer Technology Corp.1986-07-31
SOFTACT II (POLYMACON) (P830006/S002)Premier Contact Lens1986-07-31
B&L 58(TM) (ETAFILCONA) CONTACT LENS (P850039/S001)Bausch & Lomb, Inc.1986-07-31
SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH (P820040/S011)Ciba Vision Care1986-07-31
STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACING (P830061)Medtronic Cardiac Rhythm Disease Management1986-07-29
CAPSURE SP, CAPSURE, CAPSURE 2 LEADS, EXCELLENCE S, IMPULSE, IMPLUSE II EXCELLENCE SS, LEADS (P850089)Medtronic Cardiac Rhythm Disease Management1986-07-29
ABBOTT ANTI-DELTA DIAGNOSTIC KIT (RIA) (P850062/S001)Abbott Laboratories1986-07-29
GARREN GASTRIC BUBBLE (P840025/S006)American Edwards Laboratories1986-07-25
STYLES 31-34 POSTERIOR IOLS (P830056/S003)Carl Zeiss Meditec, AG1986-07-25
STYLE UV40 POSTERIOR CHAMBER LENS (P830056/S009)Carl Zeiss Meditec, AG1986-07-24
NEW JERSEY INTEGRATED KNEE REPLACEMENT SYSTEM (P830055/S010)Depuy, Inc.1986-07-24
NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI (P840024/S002)Cochlear Americas1986-07-24
HEALON (P810031/S008)Johnson & Johnson Surgical Vision, Inc.1986-07-24
SOFLENS (N16895/S043)Bausch & Lomb, Inc.1986-07-23
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S024)Advanced Cardiovascular Systems, Inc.1986-07-17
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S028)Medtronic Cardiac Rhythm Disease Management1986-07-17
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S006)General Electric Co.1986-07-17
DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS (P850072)Ciba Vision Corporation1986-07-17
ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS (P840001/S008)Medtronic Neuromodulation1986-07-14
SOFT MATE WEEKLY CLEANING SOLUTION (P810017/S004)Advanced Medical Optics, Inc.1986-07-14
SENSITIVE EYES(TM) SALINE SOLUTION (P810039/S011)Bausch & Lomb, Inc.1986-07-11
N.C.G.T. GRAFT (P800058/S003)St. Jude Medical, Inc.1986-07-11
MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS (P840040/S002)Boston Scientific Corp1986-07-11
HYDROCURVE (N17752/S026)Ciba Vision Corporation1986-07-11
NEW JERSEY INTEGRATED KNEE REPLACEMENT SYSTEM (P830055/S009)Depuy, Inc.1986-07-10
PROSTHESIS, HIP, HEMI-FEMORAL, METAL (P820024/S007)Depuy, Inc.1986-07-10
WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS (P810005/S018)Ciba Vision Care1986-07-07
ABBOTT CEA-EIA KIT (P830066/S003)Abbott Laboratories1986-07-07
SOFTHERM SOL. (N18078/S025)Advanced Medical Optics, Inc.1986-07-07
SOF!PRO-CLEAN CONTACT LENS CLEANER (P810041/S004)Lobob Laboratories, Inc.1986-07-07
KESTREL NO. 695 HEATER (P820087/S006)Atrion Medical Products, Inc.1986-07-07
KESTREL NO. 695 HEATER (P820087/S005)Atrion Medical Products, Inc.1986-07-07
ABBOTT CEA-EIA KIT (P830066/S002)Abbott Laboratories1986-07-07
DEXON (N16881/S008)Davis & Geck, Inc.1986-07-07
SILK NONABSORBABLE SUTURES, USP (N84047/S010)Davis & Geck, Inc.1986-07-02
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S002)Philips Medical Systems (Cleveland), Inc.1986-07-02
MODELS PC10 & PC21 (P820049/S006)Advanced Medical Optics, Inc.1986-07-01
ABBOTT ANTI-DELTA DIAGNOSTIC KIT (RIA) (P850062)Abbott Laboratories1986-07-01
SOFTHERM SOL. (N18078/S024)Advanced Medical Optics, Inc.1986-07-01
OPTACRYL 60 - CLEAR (P820056/S017)Paragon Vision Sciences1986-07-01
BOSTON LENS(R) LENS - CLEAR (P820065/S034)Polymer Technology Corp.1986-07-01
MODELS PC10 & PC21 (P820049/S009)Advanced Medical Optics, Inc.1986-07-01
MODELS 925, 2040, 2041, 6564 (P840068/S002)Boston Scientific1986-06-30
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S027)Medtronic Cardiac Rhythm Disease Management1986-06-30
CRYSTALENS SALINE SPRAY (P850065/S001)Stericon, Inc.1986-06-27
BOSTON LENS(R) LENS - CLEAR (P820065/S033)Polymer Technology Corp.1986-06-27
STYLE 17 & 17A POSTERIOR CHAMBER IOLS (P830033/S006)Advanced Vision Science1986-06-27
BLAIREX STERILE SALINE SOLUTION (P850045/S001)Blairex Laboratories, Inc.1986-06-27
SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS (P850077/S001)CooperVision, Inc.1986-06-25
HYDRASOFT (METHAFILCON A) CONTACT LENS (P850079/S001)CooperVision, Inc.1986-06-25
KONTUR SOFT (METHAFILCON A) CONTACT LNS (P850078/S001)Kontur Kontact Lens Co., Inc.1986-06-25
SOF PRO-CLEAN CONTACT LENS CLEANER (P810041/S005)Lobob Laboratories, Inc.1986-06-24
SOFTCON BANDAGE LENS (N17375/S011)Ciba Vision Care1986-06-24
SOFTCON (VIFILCON A) SOFT CONTACT CORRECTIVE LENS (N17554/S008)Ciba Vision Care1986-06-24
OPTACRYL 60 - CLEAR (P820056/S016)Paragon Vision Sciences1986-06-24
SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS (P820021/S008)Alcon Laboratories, Inc.1986-06-24
PARAPERM O2 CONTACT LENS (P820063/S016)CooperVision, Inc.1986-06-24
STYLE UV40 POSTERIOR CHAMBER LENS (P830056/S008)Carl Zeiss Meditec, AG1986-06-23
ETHIBOND* (N17804/S034)ETHICON, Inc.1986-06-20
ABSORBABLE SURGICAL SUTURE, USP (N14226/S006)ETHICON, Inc.1986-06-20
ABSORBABLE SURGICAL SUTURE, USP (N10389/S023)ETHICON, Inc.1986-06-20
CATGUT SUTURE (N8536/S022)ETHICON, Inc.1986-06-20
SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH (P820040/S006)Ciba Vision Care1986-06-20
ETHIBOND* (N17809/S011)ETHICON, Inc.1986-06-20
ETHILON/NUROLON NYLON SUTURES (N85316/S012)ETHICON, Inc.1986-06-20
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Track 1986 automatically

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