Atlas FDA

1993

366 FDA 510(k) clearances · PMA decision year

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◉ Watch 1993

RecordFirmDate
ENDOTAK LEAD SYSTEM (P910073)Boston Scientific1993-08-26
ACS RX FLOWTRACK (TM) 40 CORO. DILITATION CATH. (P810046/S141)Advanced Cardiovascular Systems, Inc.1993-08-24
SYSTEM -3 CLEANING/DISINFECTING STORAGE SOLUTION (P870023/S003)Advanced Medical Optics, Inc.1993-08-24
ELASTIMIDE(TM) SILICONE MODIFIED C-LOOP POST. CHAM (P900048/S002)Staar Surgical Co.1993-08-23
ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S004)Abiomed Cardiovascular, Inc.1993-08-20
CORDIS PREDATOR PTCA DILITATION CATHETER (P880003/S015)Cordis Corp.1993-08-20
SYNERGY(TM) CONVERTIBLE RAPID EXCHANGE PTCA CATH. (P840040/S039)Boston Scientific Corp1993-08-17
EXCIMER LASER MODEL PC4016(1.3MM),4026(1.6MM) (P900032/S006)Spectranetics Corp.1993-08-12
SCHNEIDER PTCA CATHETER (P880027/S026)Boston Scientific1993-08-12
MODIFIED J & C LLOP POST. CHAMBER INTRAOCULAR LENS (P820049/S053)Advanced Medical Optics, Inc.1993-08-11
STORZ IOL DISTRIBUTE/OPTICAL RADIATION (P880090/S007)Bausch & Lomb, Inc.1993-08-11
MODELS 121UV & S121UV ULTRAVIOLET-ABSORBING LENSES (P880090/S008)Bausch & Lomb, Inc.1993-08-11
LC-65 (R) DAILY CONTACT LENS CLEANER (P790024/S023)Advanced Medical Optics, Inc.1993-08-11
VISTACRYL 18(KOLFOCON A) 32(KOLFOCON B) RGP LENSES (P880035/S006)Vista Optics, Ltd.1993-08-11
HFV STAR (NEW MANUFACTURING SITE) (P880013/S002)Nellcor Puritan Bennett, Inc.1993-08-11
MEDTRONIC MODEL 5424 ELECTROCARDIOGRAM CABLE (P890003/S023)Medtronic, Inc.1993-08-10
MEDTRONIC MODEL 5423 ECG CABLE (P820003/S067)Medtronic Cardiac Rhythm Disease Management1993-08-10
MEDTRONIC(R) 14K(TM)CORONARY BALL DILATATION CATH (P870036/S024)Medtronics Interventional Vascular1993-08-09
ACS CORONARY DILATATION CATHETERS (P810046/S139)Advanced Cardiovascular Systems, Inc.1993-08-06
MEDTRONIC(R) SPIRIT(TM) CORONARY BALL. DILAT. CATH (P870036/S023)Medtronics Interventional Vascular1993-08-06
ORTHOPAK(R) BONE GROWTH STIMULATOR (P850022/S008)Ahp Eos Buyer, Inc.1993-08-06
COLLAGRAFT(TM) BONE GRAFT SUBSTITUTE (P900039/S002)Neucoll, Inc.1993-08-05
COSMOS II MODELS 284-05,283-03 PULSE GENERATOR (P830026/S058)Boston Scientific1993-08-04
MEDTRONIC(R) MODEL 5346 TEMPORARY PULSE GENERATOR (P820003/S065)Medtronic Cardiac Rhythm Disease Management1993-08-04
MODEL MFL 5000 LITHOTRIPTER (P840008/S046)Dornier Medtech America, Inc.1993-08-04
INTERTACH(R)II MODELS 262-16 (P860007/S012)Boston Scientific1993-08-04
EXCELENS (ATLAFILCON A) CONTACT LENS (P890029/S002)Ciba Vision Corporation1993-08-02
CORDIS PTCA DILATATION CATHETERS (P880003/S019)Cordis Corp.1993-08-02
ENZYMUN TEST{R} CEA (P860058/S001)Boehringer Mannheim Corp.1993-07-29
CORDIS SLEEK PTCA DILATATION CATHETERS (P880003/S018)Cordis Corp.1993-07-29
SCIMED(R) PIVOT (TM) PTCA CATHETER (P860019/S074)Scimed Life Systems, Inc.1993-07-29
STACK PERFUSION IV CORONARY DILATION CATHETER (P810046/S122)Advanced Cardiovascular Systems, Inc.1993-07-29
PHYSIO-STIM(TM) (P850007/S013)Orthofix, Inc.1993-07-29
GAS PERMEABLE COMFORTCARE(TM)WETTING/SOAKING SOLUT (P820053/S022)Advanced Medical Optics, Inc.1993-07-28
CLINICAL ASSAYS (TM) GAMMADAB(R) [ 125 I ] (P790032/S003)Incstar Corp.1993-07-23
ACS EDGE(TM) CORONARY DILITATION CATHETER (P810046/S130)Advanced Cardiovascular Systems, Inc.1993-07-23
NEW JERSEY LCS(R) TOTAL KNEE SYSTEM (P830055/S023)Depuy, Inc.1993-07-22
SCIMED QUANTUM(TM) PTCA CATHETER (P860019/S052)Scimed Life Systems, Inc.1993-07-21
CORDIS PREDATOR PTCA DILITATION CATHETER (P880003/S014)Cordis Corp.1993-07-21
CHANGES TO PINKERTON & OMEGA CORO.DIL. CATHETERS (P810046/S126)Advanced Cardiovascular Systems, Inc.1993-07-21
PROVISC TM VISCOELASTIC PREPARATION (P890047/S001)Alcon Research, Ltd.1993-07-20
MODEL MFL 5000 MOBILE LITHOTRIPTER (P840008/S044)Dornier Medtech America, Inc.1993-07-19
RGP CONTACT LENS,SGP (TELE A),SGP II(TELE B) (P840055/S030)The Lifestyle Co., Inc.1993-07-12
ABIOMED BVS(R) 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S001)Abiomed Cardiovascular, Inc.1993-07-12
REALITY(TM) VAGINAL POUCH (P910064/S002)The Female Health Co.1993-07-09
SLIDER (TM)3.4F LONG BALLOON DILATATION PTCA CATH (P840040/S037)Boston Scientific Corp1993-07-08
AIA-PACK PSA (P910065)Tosoh Bioscience, Inc.1993-07-07
CHANGES TO ALPHA /STREAK ADD BALLOON LENGTHS (P810046/S125)Advanced Cardiovascular Systems, Inc.1993-07-07
SLEEK PTCA DILATATION CATHETERS W/3 & 4CM BALLONS (P880003/S013)Cordis Corp.1993-07-07
MEDTRONIC MODEL 8360 MICRO MINIX (P850051/S039)Medtronic, Inc.1993-07-02
HANCOCK BIOPROSTHESIS MODELS 242,342,343C,342R (P870078/S003)Medtronic, Inc.1993-07-02
HANCOCK MODIFIED ORIFICE BIOPROSTHESIS (P790007/S011)Medtronic Heart Valves1993-07-02
BAUSCH & LOMB (HEFILCON C) CONTACT LENSES (N17676/S024)Bausch & Lomb, Inc.1993-07-02
SCIMED(R) NC RALLY(TM) PTCA CATHETER (P860019/S068)Scimed Life Systems, Inc.1993-07-01
REACH(TM).14 PTCA CATHETER (P850021/S022)Abbott Vascular, Inc.1993-07-01
ABBOTT IMX AFP ADDITIONAL PURIFICATION STEP (P820060/S006)Abbott Laboratories1993-07-01
GORE-TEX(R) EXPANDED PTFE SUTURE (P820083/S013)W. L. Gore & Associates, Inc.1993-07-01
ALLERGAN(R) PRESERVED SALINE SOL.SPEC CHANGE (N18020/S038)Advanced Medical Optics, Inc.1993-06-29
META DDDR PACING SYSTEM MODEL 1254/FUNC.1250H (P900070/S001)St. Jude Medical, Cardiac Rhythm Management Divisi1993-06-29
HYDRON(R) (POLYMACON) HYDROPHILIC CONTACT LENSES (P910029/S001)Les Laboratories Blonchard1993-06-29
CCS MODEL 333 PACEMAKER SYSTEM (P890039/S008)Cardiac Control Systems, Inc.1993-06-24
COLLACOTE(R),COLLATAPE(R),COLLAPLUG(R), DRESSINGS (P840062/S004)Integra Lifesciences Corp.1993-06-24
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S052)Biomerieux Vitek, Inc.1993-06-24
EXCIMER LASER (LASER CATHETER-MODEL PC4010(1.3MM)) (P900032/S001)Spectranetics Corp.1993-06-22
FLUOROPERM 60 (PAFLUFOCON B) CONTACT LENS (P870024/S029)CooperVision, Inc.1993-06-22
EXCIMER LASER (LASER CATHETER-MODEL PC4021(1.6MM)) (P900032/S002)Spectranetics Corp.1993-06-22
CSI COLOURS CONTACT LENSES (N17987/S024)Ciba Vision Corporation1993-06-22
MODEL 9600 NETWORK PROGRAMMER (P820018/S058)St. Jude Medical, Inc.1993-06-18
OLYMPIX & SLEUTH XT PTCA CATHETERS W/3CM BALLOONS (P880003/S011)Cordis Corp.1993-06-17
INFUSAID IMPLANTABLE INFUSION PUMP MODEL 400 (P800036/S029)Intera Oncology1993-06-17
MODEL 9600 VERSION SC.11 PERSONALITY MODULE SOFT (P880038/S023)St. Jude Medical, Inc.1993-06-17
CORDIS ORION II STEERABLE BALLOON CATHETER (P890032/S014)Cordis Corp.1993-06-17
OLYMPIX & SLEUTH XT PTCA CATHETERS W/4CM BALLOONS (P880003/S012)Cordis Corp.1993-06-17
SLEEK PTCA DILATION CATHETER (P880003/S010)Cordis Corp.1993-06-17
SCIMED(R) PTCA CATHETER SHADOW(TM)P-14 (P860019/S056)Scimed Life Systems, Inc.1993-06-15
SCIMED(R) PTCA CATHETER NC COBRA 14 (P860019/S066)Scimed Life Systems, Inc.1993-06-15
SCIMED(R) PTCA CATHETER NC COBRA 14 (P860019/S067)Scimed Life Systems, Inc.1993-06-14
EBI BONE HEALING SYSTEM(R)-MODEL 123 (P790002/S014)Ahp Eos Buyer, Inc.1993-06-14
ACCESS MOBILITY SYSTEM (P900050/S001)Quest Technologies Corp.1993-06-14
ULTRA CARE (TM) NEUTRALIZING TABLET (P850088/S026)Advanced Medical Optics, Inc.1993-06-09
SURGICAL SIMPLEX(R) P BONE CEMENT (N17003/S004)Howmedica Corp.1993-06-08
NEW JERSEY LCS(R) UNICOMPARTMENTAL KNEE (P910016/S002)Depuy, Inc.1993-06-08
HELISTAT (R) ABSORBABLE COLLAGEN HEMOSTATIC AGENT (P850010/S014)Integra LifeSciences Corporation1993-06-08
NEW JERSEY LCS(R) TOTAL KNEE SYSTEM (P830055/S029)Depuy, Inc.1993-06-04
NEW JERSEY LCS(R) TOTAL KNEE SYSTEM (P830055/S027)Depuy, Inc.1993-06-04
AFP CARDIAC PACING SYSTEM (P830045/S042)St. Jude Medical, Inc.1993-06-04
NEW JERSEY LCS(R) TOTAL KNEE SYSTEM (P830055/S025)Depuy, Inc.1993-06-04
NEW JERSEY LCS(R) TOTAL KNEE SYSTEM (P830055/S028)Depuy, Inc.1993-06-04
SOLUS (R) MODELS 2002,2003,SYNCHRONY(R)2022,2023 (P880086/S021)ABBOTT MEDICAL1993-06-04
USCI(R) SPRINT(TM) BALL. DIL. CATH. WITH BANKA(TM) (P790017/S043)Medtronic, Ireland1993-06-04
MEDTRONIC MODEL 9858 A SOFTWARE DISKETTES (P890003/S020)Medtronic, Inc.1993-06-03
MAESTRO(R) RELEASE III SOFTWARE 5OO SERIES (P860027/S009)Cardiac Control Systems, Inc.1993-06-03
ROTABLATOR(R) (P900056)Boston Scientific Corp1993-05-28
SENSITIVE EYES(TM) SALINE SOLUTION (2ML) SIZE (P810039/S017)Bausch & Lomb, Inc.1993-05-28
COLLAGRAFT(TM) BONE GRAFT SUBSTITUTE (P900039)Neucoll, Inc.1993-05-28
ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS (P890072/S008)Progressive Chemical Research , Ltd.1993-05-27
TRANSAIRE(TM) RIGID GAS PERMEABLE CONTACT LENSES (P890044/S026)Rand Scientific Corp.1993-05-27
RGP CONTACT LENS,SGP (TELE A),SGP II(TELE B) (P840055/S031)The Lifestyle Co., Inc.1993-05-27
RIGID GAS PERMEABLE CONTACT LENSES (P900001/S009)The Lifestyle Co., Inc.1993-05-27
VH8500 HYPERTHERMIA TREATMENT SYSTEM (P880078/S010)Cook, Inc.1993-05-21
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Track 1993 automatically

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