Atlas FDA

1984

260 FDA 510(k) clearances · PMA decision year

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◉ Watch 1984

RecordFirmDate
CHROMIC GUT SUTURE (N84381/S004)Deknatel, Inc.1984-07-12
HYDRACON(R) CONTACT LENSES (P820017/S002)Hydracon1984-07-11
ETHILON/NUROLON NYLON SUTURES (N85316/S011)ETHICON, Inc.1984-07-11
GK-101E CARIES REMOVAL AGENT/SYSTEM (P830035)Indevus Pharmaceuticals, Inc.1984-07-06
DURASOFT(R) 3 FOR EXT WEAR (P830037/S003)Alcon Laboratories, Inc.1984-07-05
ANGELCHIK ANTI-REFLUX PROSTHESIS (P790006/S004)Allergan, Inc.1984-07-02
ANGELCHIK ANTI-REFLUX PROSTHESIS (P790006/S003)Allergan, Inc.1984-07-02
NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054)Coherent Medical Division1984-07-02
PREFLEX AND FLEXCARE SOL. (N18143/S025)Alcon Laboratories1984-06-29
FLEXSOL (N17974/S037)Alcon Laboratories1984-06-29
SOFTACT(TM) (DELTAFILCON A) (P800070/S003)Premier Contact Lens1984-06-26
OPUS - III CONTACT LENSES (P820074/S002)Wesley Jessen Corp.1984-06-25
ABBOTT AFP (P780005)Abbott Laboratories1984-06-25
BOSTON LENS(R) LENS - CLEAR (P820065/S006)Polymer Technology Corp.1984-06-15
TCO2M MODEL 818 MONITOR (P810022/S003)Novametrix Medical Systems, Inc.1984-06-15
TCO2M MODEL 818 MONITOR (P810022/S004)Novametrix Medical Systems, Inc.1984-06-15
BOSTON LENS(R) CONDITIONING SOLUTION (P820070/S001)Polymer Technology Corp.1984-06-13
PLASMA SEPARATION SYSTEM (P820032/S002)Fenwal, Inc.1984-06-13
PLASMA SEPARATION SYSTEM (P820032/S003)Fenwal, Inc.1984-06-13
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S008)Advanced Cardiovascular Systems, Inc.1984-06-08
OPUS - III CONTACT LENSES (P820074/S003)Wesley Jessen Corp.1984-06-08
OPTACRYL 60 - CLEAR (P820056/S005)Paragon Vision Sciences1984-06-08
SAUFLON(R) PW (LIDOFILCON B) (P790020/S011)Advanced Medical Optics, Inc.1984-06-08
AMIKACIN ELUTION DISK FOR AUTOBAC (N50485/S009)Organon Teknika Corp.1984-06-08
ZYDERM COLLAGEN IMPLANT (ZYDERM CI) (P800022/S007)Allergan1984-06-08
DURASOFT(R) 3 FOR EXT WEAR (P830037/S001)Alcon Laboratories, Inc.1984-06-08
AMERSHAM AFP (P780006)Ortho Clinical Diagnostics1984-06-07
PDS SUTURE (DYED) (N18331/S015)ETHICON, Inc.1984-06-05
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S008)Medtronic Cardiac Rhythm Disease Management1984-06-04
OPTI-ZYME(TM) ENZYAMTIC CLEANER (P820001/S006)Alcon Laboratories1984-06-04
SOF!PRO-CLEAN CONTACT LENS CLEANER (P810041/S003)Lobob Laboratories, Inc.1984-06-04
PARAPERM O2 CONTACT LENS (P820063/S005)CooperVision, Inc.1984-06-04
INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4 (P800036/S005)Intera Oncology1984-06-04
HYSKON (32% DEXTRAN 70) (N17511/S005)Coopervision Surgical1984-05-30
THE BLAIREX SYSTEM (P800028/S010)Blairex Laboratories, Inc.1984-05-25
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S010)St. Jude Medical, Inc.1984-05-21
CORDIS PROGRAMMABLE NEURAL STIMULATOR MODELS 900A, (P800040/S006)Cordis Corp.1984-05-21
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S011)St. Jude Medical, Inc.1984-05-21
BILEAFLET-CENTER OPENING CARDIAC VALVE (P810002/S004)ABBOTT MEDICAL1984-05-16
SUPRAMID EXTRA SUTURES (N80838/S006)S. Jackson, Inc.1984-05-15
EASY EYES (TM) (P830009/S003)Eaton Medical Corp.1984-05-15
BJORK-SHILEY CARDIAC VALVE (P780008/S011)Shiley, Inc.1984-05-15
HEALON (P810031/S004)Johnson & Johnson Surgical Vision, Inc.1984-05-15
THE BLAIREX SYSTEM (P800028/S011)Blairex Laboratories, Inc.1984-05-11
HEALON (P810031/S005)Johnson & Johnson Surgical Vision, Inc.1984-05-09
API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM (P800029/S010)Analytical Products, Inc.1984-05-04
CORAB-M (P830014/S001)Abbott Laboratories1984-05-03
SLEEP SENTRY(TM) (P810044/S003)Diabetes Sentry Products, LLC1984-05-03
PDS(TM) SUTURE (CLEAR) (N18387/S007)ETHICON, Inc.1984-05-02
ETHIBOND* (N17804/S029)ETHICON, Inc.1984-05-02
SOFLENS(R) ENZYMATIC CONTACT LENS CLEANER (N17654/S008)Advanced Medical Optics, Inc.1984-05-02
VICRYL (POLYGLACTIN 910) SUTURE (N17472/S037)ETHICON, Inc.1984-05-02
PDS SUTURE (DYED) (N18331/S009)ETHICON, Inc.1984-05-02
ETHIBOND* (N17809/S006)ETHICON, Inc.1984-05-02
PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S (N16374/S025)ETHICON, Inc.1984-05-02
VICRYL MESH (N17482/S031)ETHICON, Inc.1984-05-02
COATED VICRYL ABSORBABLE SUTURE (UNDYED/BRAIDED) (N18176/S011)ETHICON, Inc.1984-05-02
COATED VICRYL ABSORBABLE SURGICAL SUTURE (DYED/BRA (N18175/S012)ETHICON, Inc.1984-05-02
SOFT-CARE DISINFECTION REGIMEN FOR CONTACT LENSES (P790029/S005)Advanced Medical Optics, Inc.1984-05-01
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S009)Medtronic Cardiac Rhythm Disease Management1984-04-27
PLAIN GUT STERILE ABSORBABLE SUTURES (N83038/S018)Davis & Geck, Inc.1984-04-27
DURASOFT(R) 3 FOR EXT WEAR (P830037)Alcon Laboratories, Inc.1984-04-24
API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM (P800029/S009)Analytical Products, Inc.1984-04-24
RIANEN 3H (P800061/S006)Dupont Legal1984-04-24
TCPCO2 MONITORING SYSTEM (P820025/S001)Narco Scientific1984-04-18
SOFT MATE(R) DW (HEFILICON A) CONTACT LENS (N17367/S012)Wesley Jessen Corp.1984-04-16
NATUREVUE CONTACT LENSE (N17676/S009)Bausch & Lomb, Inc.1984-04-16
PROSTHESIS, HIP, HEMI-FEMORAL, METAL (P820024/S002)Depuy, Inc.1984-04-11
AMIKACIN ELUTION DISK FOR AUTOBAC (N50485/S011)Organon Teknika Corp.1984-04-10
SAUFLON(R) PW (LIDOFILCON B) (P790020/S018)Advanced Medical Optics, Inc.1984-04-10
ABSORBABLE SURGICAL SUTURE, USP (N10389/S022)ETHICON, Inc.1984-04-04
THE SOFT RINSE SYSTEM (P800060/S005)Dow Corning Corp. Healthcare Industries Materials1984-04-04
THE HORIZON SYSTEM (P810009/S004)Horizon Pharmacal, Inc.1984-04-04
OSTEOSTIM(R) (P790005/S023)Ahp Eos Buyer, Inc.1984-04-04
WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS (P810005/S010)Ciba Vision Care1984-04-04
CATGUT SUTURE (N8536/S021)ETHICON, Inc.1984-04-04
TRESOFT SOFT CONTACT LENSE (N17855/S004)Ciba Vision Care1984-03-29
BOSTON LENS(R) CONDITIONING SOLUTION (P820070/S004)Polymer Technology Corp.1984-03-29
HYDRO MARC LENSES (HYDROPHILIC) (N18033/S009)Vistakon, Johnson & Johnson Vision Products, Inc.1984-03-29
MERSILENE*POLYESTER SUTURE (N12815/S019)ETHICON, Inc.1984-03-29
HYDRON HYDROPHILIC CONTACT LENS (P780007/S014)CooperVision, Inc.1984-03-29
PDS SUTURE (DYED) (N18331/S013)ETHICON, Inc.1984-03-27
ETHIBOND* (N17809/S009)ETHICON, Inc.1984-03-27
PDS(TM) SUTURE (CLEAR) (N18387/S009)ETHICON, Inc.1984-03-27
VICRYL (POLYGLACTIN 910) SUTURE (N17472/S038)ETHICON, Inc.1984-03-27
VICRYL MESH (N17482/S032)ETHICON, Inc.1984-03-27
COATED VICRYL ABSORBABLE SUTURE (UNDYED/BRAIDED) (N18176/S012)ETHICON, Inc.1984-03-27
COATED VICRYL ABSORBABLE SURGICAL SUTURE (DYED/BRA (N18175/S013)ETHICON, Inc.1984-03-27
ETHIBOND* (N17804/S032)ETHICON, Inc.1984-03-27
HYVISC(R) (P810025/S002)Bausch & Lomb, Inc.1984-03-26
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S005)St. Jude Medical, Inc.1984-03-23
COSMOS(TM) SYSTEM (P830026)Boston Scientific1984-03-23
MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S (P830045)St. Jude Medical, Inc.1984-03-22
THE BLAIREX SYSTEM (P800028/S009)Blairex Laboratories, Inc.1984-03-22
BAUSCH & LOMB STERILE PRESERVED SALINE SOLN (P800024/S009)Bausch & Lomb, Inc.1984-03-19
SENSITIVE EYES(TM) SALINE & CLEANING SOLUTION (P820031/S002)Bausch & Lomb, Inc.1984-03-19
HYDRO MARC LENSES (HYDROPHILIC) (N18033/S008)Vistakon, Johnson & Johnson Vision Products, Inc.1984-03-19
PARAPERM O2 CLEAR & BLUE LENS (P820062/S001)Salvatori Ophthalmics Mfg. Corp.1984-03-16
PROSTHESIS, HIP, HEMI-FEMORAL, METAL (P820024/S001)Depuy, Inc.1984-03-16
BOSTON LENS(R) CLEANER (P820069/S001)Polymer Technology Corp.1984-03-16
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Track 1984 automatically

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