Atlas FDA

1991

481 FDA 510(k) clearances · PMA decision year

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◉ Watch 1991

RecordFirmDate
BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032/S001)Bio-Rad1991-03-14
VIRATYPE HUMAN PAPILLOMAVIRUS DNA TYPING KIT (P890064)Qiagen Gaithersburg, Inc.1991-03-11
SYNCHROMED(TM) INFUSION SYSTEM (P860004/S013)Medtronic, Inc.1991-03-11
UVAR PHOTOPHERESIS SYSTEM (TSP-101) BLOOD TUBING (P860003/S019)Therakos Development Limited1991-03-11
BIAS(R) FIBER METAL TOTAL HIP SYSTEM (P850061/S002)Zimmer, Inc.1991-03-08
HEART TRAK PTCA CATHETER (P840040/S023)Boston Scientific Corp1991-03-08
LEOCOR,INC. PICOCATH CATHETER 2,2.5,3,3.5, BALLOON (P890001/S003)Leocor, Inc.1991-03-08
SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S002)Howmedica Corp.1991-03-07
SURGICAL SIMPLEX(R) P BONE CEMENT (N17003/S002)Howmedica Corp.1991-03-07
APPLIED LABORATORIES STERILE SALINE SOLUTION (P870002/S009)Applied Laboratories, Inc.1991-03-07
OTI-05 & LATHE-40 (POLYMACON) LATHE-CUT HYDROPHILI (P890031/S001)Ocular Technologies, Inc.1991-03-06
LENS PLUS STERILE SALINE SOLUTION (BUFFERED) (N18020/S034)Advanced Medical Optics, Inc.1991-03-06
THE SOFT RINSE SYSTEM (P800060/S007)Dow Corning Corp. Healthcare Industries Materials1991-03-05
ETI-AB-HAVK (P890019/S001)Diasorin1991-03-01
MODELS A21-A & A21-B POSTERIOR CHAMBER INTRAOCULAR (P900053)Vision Technologies Intl., Inc.1991-02-28
BAUSCH & LOMB RENEW (R) SALINE SOLN. (BL-101-BEU13 (P800024/S016)Bausch & Lomb, Inc.1991-02-28
MODIFIED J&C LOOP POST. CHAMBER INTRAOCULAR LENS (P900037)Medical Development Research, Inc.1991-02-28
TRI POL 43 CONTACT LENS (P780013/S005)Gbf Contact Lenses, Inc.1991-02-26
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S025)Trimedyne, Inc.1991-02-25
BIOBRANE (R) II BLUE LABEL PRODUCT (P870069/S003)Udl Laboratories, Inc.1991-02-22
ANTERIOR CHAMBER MONOFOCAL (P860034/S008)Advanced Medical Optics, Inc.1991-02-21
POSTERIOR CHAMBER MONOFOCAL (P820049/S052)Advanced Medical Optics, Inc.1991-02-21
SIMPSON CORONARY ATHEROCATH(TM) (P890043/S008)Abbott Vascular1991-02-21
SILICONE ELASTOMERIC POSTERIOR CHAMBER LENSES (P880081/S009)Johnson & Johnson Surgical Vision, Inc.1991-02-21
SILICON ELASTOMERIC POSTERIOR CHAMBER INTRAOCULAR (P880081/S006)Johnson & Johnson Surgical Vision, Inc.1991-02-21
PHYSIO-STIM(R) (P850007/S011)Orthofix, Inc.1991-02-15
CONTACT LENSES (P820051/S012)Ocu-Ease Optical Products, Inc.1991-02-15
SYNCHRONY II MODEL 2023M/S & SOLAS MODEL 2003M/S (P880086/S007)ABBOTT MEDICAL1991-02-13
UVAR PHOTOPHERESIS SYSTEM (TSP-101) BLOOD TUBING (P860003/S018)Therakos Development Limited1991-02-13
FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS (P870024/S023)CooperVision, Inc.1991-02-12
BAUSCH & LOMB FW TORIC (LIDOFILCON) CONTACT LENSES (P880029/S010)Bausch & Lomb, Inc.1991-02-12
O-PERM F60 RGP CONTACT LENS (P890046/S007)Optical Polymer Research, Inc.1991-02-12
LASTAC SYSTEM (P870071/S007)G V Medical, Inc.1991-02-08
OXYCEL OXIDIZED (N5798/S005)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
AID(R) B/BR (P830060/S022)Boston Scientific1991-02-08
ZYDERM COLLAGEN IMPLANT (ZYDERM CI) (P800022/S016)Allergan1991-02-08
DURALOC(TM) 300S ACETABULAR CUP WITH POROCOAT(TM) (P880025/S001)Depuy, Inc.1991-02-08
OXYCELL (N5798/S006)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-02-08
TORIC AND OPTIMA (HEFILCON B) CONTACT LENSES (N17676/S022)Bausch & Lomb, Inc.1991-02-07
SOF-FORM ALLVUE MULTIFOCAL (POLYMACON) CONTACT LEN (P840006/S006)Salvatori Ophthalmics Mfg. Corp.1991-02-07
MEDSTONE 1050 EXTRACORPOREAL SHOCK WAVE LITHOTRIPT (P870015/S009)Medstone Intl., Inc.1991-02-06
LEGEND PULSE GENERATORS & MICRO MINIX (P850051/S028)Medtronic, Inc.1991-02-06
MODELS 5342 & 5345 TEMPORARY PULSE GENERATORS (P820003/S057)Medtronic Cardiac Rhythm Disease Management1991-02-06
PROSORBA(TM) COLUMN (P850020/S003)Fresenius Hemocare, Inc.1991-02-06
PARAPERM O2 (PASIFOCON A) CONTACT LENS (P820063/S048)CooperVision, Inc.1991-02-05
PARAPERM E.W. (PASIFOCON A) RGP CONTACT LENS (P850038/S015)Paragon Optical Co.1991-02-05
FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS (P870024/S024)CooperVision, Inc.1991-02-05
LENS PLUS STERILE SALINE SOLUTION (BUFFERED) (N18020/S035)Advanced Medical Optics, Inc.1991-02-05
AOSEPT(R) & LENSEPT(R) SOLUTIONS (P820040/S029)Ciba Vision Care1991-02-04
BOSTON(R) RXD(TM) & ENVISION(TM) RGP CONTACT LENS (P860022/S032)Bausch & Lomb1991-02-04
BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS (P820065/S073)Polymer Technology Corp.1991-02-04
HYBRID PTCA CATHETER (P850021/S012)Abbott Vascular, Inc.1991-02-04
PROACT TW PTCA CATHETER (P840040/S020)Boston Scientific Corp1991-01-31
MODEL 283 PULSE GENERATOR MODEL 370 PROGRAMMER (P830045/S028)St. Jude Medical, Inc.1991-01-31
SYNCHRONY II MODEL 2023M/S & SOLAS MODEL 2003M/S (P880086/S008)ABBOTT MEDICAL1991-01-31
1YCLO-TRAC SP WHOLE BLOOD & SERUM/PLASMA ASSAYS (P890065/S001)DiaSorin, Inc.1991-01-30
BUSHINDER THRUFLEX OVER-THE-WIRE BALLOON CATHETER (P870036/S010)Medtronics Interventional Vascular1991-01-30
HEART TRAK PTCA CATHETER (P840040/S022)Boston Scientific Corp1991-01-30
MAESTRO SERIES 500 P.G.& MODEL 1006 PACEMAKER PROG (P860027/S007)Cardiac Control Systems, Inc.1991-01-30
SCIMED PTCA DILATATION CATHETER (P860019/S030)Scimed Life Systems, Inc.1991-01-25
VISTAKON (ETAFILICON A) HYDROPHILIC CONTACT LENS (N18033/S025)Vistakon, Johnson & Johnson Vision Products, Inc.1991-01-24
SIMPSON CORONARY ATHEROCATH(TM) (P890043/S007)Abbott Vascular1991-01-22
DORNIER MPL 9000 - RENAL APPLICATION (P840008/S027)Dornier Medtech America, Inc.1991-01-18
SCIMED PTCA DILATATION CATHETER-ACE ADVANTAGE(TM) (P860019/S038)Scimed Life Systems, Inc.1991-01-18
STERIDYNE SOFT (HYDROPHILIC) LENS SOLUTION (P890067/S001)Steridyne Laboratories, Inc.1991-01-18
PRESERVED SOFT MATE(R) CONSEPT(R)2 NEUT.& RINS SOL (P840066/S026)Advanced Medical Optics, Inc.1991-01-18
MICROSOFTRAC (R) PTCA CATHETER (P880027/S009)Boston Scientific1991-01-18
SCHNEIDER MAGNUM-MEIER(R) PTCA CATHETER (P880027/S010)Boston Scientific1991-01-18
ACS HP CORONARY DILATATION CATHETER (P810046/S094)Advanced Cardiovascular Systems, Inc.1991-01-17
MODEL 721A ULTRAVIOLET LIGHT-ABSORBING LENS (POST) (P810055/S041)Advanced Medical Optics, Inc.1991-01-14
ACS(R) DILATATION CATHETERS (P810046/S087)Advanced Cardiovascular Systems, Inc.1991-01-14
STAY WET 3 & STAY WET 3 (SA) (P870029/S004)Advanced Medical Optics, Inc.1991-01-14
SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS (P850077/S013)CooperVision, Inc.1991-01-14
DE-STAT 3 CLEANING SOAKING CONDITIONING SOLUTION (P870023/S002)Advanced Medical Optics, Inc.1991-01-14
MODELS SS-25NB & SS-26NB SILICONE ELASTOMERIC POST (P880081/S007)Johnson & Johnson Surgical Vision, Inc.1991-01-14
EBK (P870048/S001)Diasorin1991-01-10
PERMAFLEX THIN & THIN COLOR COLLECTION (N17679/S023)CooperVision, Inc.1991-01-10
MAESTRO SERIES 500 P.G.& MODEL 1006 PACEMAKER PROG (P860027/S006)Cardiac Control Systems, Inc.1991-01-10
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S009)Dade Intl., Inc.1991-01-08
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S010)Dade Intl., Inc.1991-01-08
CPI SUTURELESS MYOCARDIAL LEAD MODEL 4320 (P830060/S021)Boston Scientific1991-01-07
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Track 1991 automatically

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