Atlas FDA

1988

640 FDA 510(k) clearances · PMA decision year

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◉ Watch 1988

RecordFirmDate
MODELS PC10 & PC21 (P820049/S036)Advanced Medical Optics, Inc.1988-08-16
MODEL 304 (ULTRA C-LOOP) (P860059/S007)Advanced Medical Optics, Inc.1988-08-16
COOPER(TM) 38 (POLYMACON) HYDROPHILIC CONTACT LENS (P810057/S003)CooperVision, Inc.1988-08-11
SOFTHERM SOL. (N18078/S039)Advanced Medical Optics, Inc.1988-08-11
QUASEPT II (N17679/S018)CooperVision, Inc.1988-08-11
ACTIVITRAX MODELS 8400, 8402, 8403 (P850051/S016)Medtronic, Inc.1988-08-11
MODELS 019B, 019C, 019E, 019F, 019J, & 019K (P810055/S030)Advanced Medical Optics, Inc.1988-08-11
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS (N50510/S032)Biomerieux Vitek, Inc.1988-08-10
VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM (P870036/S001)Medtronics Interventional Vascular1988-08-10
MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS (P840040/S008)Boston Scientific Corp1988-08-10
MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S (P830045/S013)St. Jude Medical, Inc.1988-08-10
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS (N50510/S033)Biomerieux Vitek, Inc.1988-08-10
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR (P830070/S020)Ciba Vision Corporation1988-08-09
CLERZ LUBRICATING & REWETTING EYE DROPS (P800034/S011)Alcon Laboratories1988-08-09
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR (P830070/S015)Ciba Vision Corporation1988-08-09
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR (P830070/S019)Ciba Vision Corporation1988-08-09
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR (P830070/S014)Ciba Vision Corporation1988-08-09
PARAPERM O2 CONTACT LENS (P820063/S036)CooperVision, Inc.1988-08-09
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR (P830070/S018)Ciba Vision Corporation1988-08-09
OCUSIL(TM) CONTACT LENS (P840050/S035)O.S.I. Corp.1988-08-09
OCUSIL(TM) CONTACT LENS (P840050/S036)O.S.I. Corp.1988-08-09
PARAPERM O2 CONTACT LENS (P820063/S035)CooperVision, Inc.1988-08-09
ULTRAZYME PROTEIN CLEANER (P860061/S003)Advanced Medical Optics, Inc.1988-08-09
SOFT MATE(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM (P840066/S013)Advanced Medical Optics, Inc.1988-08-09
BOSTON LENS(R) LENS - CLEAR (P820065/S057)Polymer Technology Corp.1988-08-08
SORBIC ACID PRESERVED LENS LUBRICANT (P850075/S005)Paco Pharmaceutical Services, Inc.1988-08-08
NON-PRESERVED SALINE SOLUTION (P850025/S006)Paco Pharmaceutical Services, Inc.1988-08-08
CHLORHEXIDINE-THIMEROSAL-EDETATE DISODIUM DISINFEC (P850012/S004)Paco Pharmaceutical Services, Inc.1988-08-08
SOFT MATE(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM (P840066/S012)Advanced Medical Optics, Inc.1988-08-08
THIMEROSAL PRESERVED SALINE SOLUTION (P850047/S003)Paco Pharmaceutical Services, Inc.1988-08-08
SORBIC ACID PRESERVED DAILY CLEANER (P850076/S005)Paco Pharmaceutical Services, Inc.1988-08-08
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR (P830070/S016)Ciba Vision Corporation1988-08-08
CIBA VISION LENS DROPS (P860060/S001)Ciba Vision Care1988-08-08
IMPROVED SOACLENS (P830071/S001)Alcon Laboratories1988-08-05
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S027)Telectronics Pacing Systems, Inc.1988-08-04
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S037)Telectronics Pacing Systems, Inc.1988-08-04
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S026)Telectronics Pacing Systems, Inc.1988-08-04
THIMEROSAL PRESERVED SALINE SOLUTION (P850047/S002)Paco Pharmaceutical Services, Inc.1988-07-29
CHLORHEXIDINE-THIMEROSAL-EDETATE DISODIUM DISINFEC (P850012/S003)Paco Pharmaceutical Services, Inc.1988-07-29
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S017)General Electric Co.1988-07-29
HYDROGEN PEROXIDE DISINFECTION SOLUTION (P850026/S004)Paco Pharmaceutical Services, Inc.1988-07-29
SORBIC ACID PRESERVED LENS LUBRICANT (P850075/S004)Paco Pharmaceutical Services, Inc.1988-07-29
HEALON (P810031/S011)Johnson & Johnson Surgical Vision, Inc.1988-07-29
CHARTER LABS SALINE SOLUTION (P840069/S005)Paco Pharmaceutical Services, Inc.1988-07-29
NON-PRESERVED SALINE SOLUTION (P850025/S005)Paco Pharmaceutical Services, Inc.1988-07-29
OPTACRYL 60 - CLEAR (P820056/S042)Paragon Vision Sciences1988-07-28
SCANLENS (SCAFILCON A CONTACT LENS) (P850033/S001)Ciba Vision Corporation1988-07-28
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S036)Telectronics Pacing Systems, Inc.1988-07-28
SOFT MATE(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM (P840066/S011)Advanced Medical Optics, Inc.1988-07-28
ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 (P830062/S012)Nidek, Inc.1988-07-28
OPTACRYL 60 - CLEAR (P820056/S041)Paragon Vision Sciences1988-07-28
SOFTMATE SOLUTION (N18073/S017)Advanced Medical Optics, Inc.1988-07-27
SOFT MATE COMFORT DROPS (P800018/S011)Advanced Medical Optics, Inc.1988-07-27
DIASONICS NMR IMAGING SYSTEM (P830053/S030)Diasonics, Inc.1988-07-27
SOFTHERM SOL. (N18078/S037)Advanced Medical Optics, Inc.1988-07-27
SOFT-CARE DISINFECTION REGIMEN FOR CONTACT LENSES (P790029/S017)Advanced Medical Optics, Inc.1988-07-27
SOFTHERM SOL. (N18078/S036)Advanced Medical Optics, Inc.1988-07-27
ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7 (P860008/S003)Cardio Command1988-07-27
RESONEX RX4000{TM} MAGNETIC RESONANCE IMAGING SYST (P860062/S002)Resonex, Inc.1988-07-27
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S019)Philips Medical Systems (Cleveland), Inc.1988-07-27
AMVISC (R) (P810025/S011)Bausch & Lomb, Inc.1988-07-26
AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL (P830060/S006)Boston Scientific1988-07-25
NEW JERSEY INTEGRATED KNEE REPLACEMENT SYSTEM (P830055/S012)Depuy, Inc.1988-07-25
WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS (P810005/S020)Ciba Vision Care1988-07-25
MAGNETOM (P830081/S022)Siemens Corp.1988-07-25
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S028)St. Jude Medical, Inc.1988-07-25
POLYQUAT DISINFECTION SYSTEM (P830034/S003)Alcon Laboratories1988-07-21
AUTOBAC MIC TEST SYSTEM (N50524/S027)Organon Teknika Corp.1988-07-21
BOSTON LENS(R) LENS - CLEAR (P820065/S056)Polymer Technology Corp.1988-07-21
BOSTON LENS(R) LENS - CLEAR (P820065/S055)Polymer Technology Corp.1988-07-21
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S038)Telectronics Pacing Systems, Inc.1988-07-21
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S028)Telectronics Pacing Systems, Inc.1988-07-21
SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS (P850077/S006)CooperVision, Inc.1988-07-21
WET-N-SOAK (P870037/S002)Advanced Medical Optics, Inc.1988-07-21
AUTOBAC MIC TEST SYSTEM (N50524/S024)Organon Teknika Corp.1988-07-20
SILK SURGICAL SUTURES (N85143/S007)Sharpoint, Inc.1988-07-19
SORBIC ACID PRESERVED DAILY CLEANER (P850076/S003)Paco Pharmaceutical Services, Inc.1988-07-19
STERIDYNE STERILE PRESERVED SALINE SOLUTION (P870007/S001)Optopics Laboratories Corp.1988-07-19
PROSTHESIS, HIP, HEMI-FEMORAL, METAL (P820024/S012)Depuy, Inc.1988-07-19
SCIMED PTCA DILATATION CATHETER (P860019/S009)Scimed Life Systems, Inc.1988-07-18
J-COLL(TM) COLLAGEN ABSORBABLE HEMOSTAT (P830079/S006)ETHICON, Inc.1988-07-18
FIBREL (P850053/S001)Mentor Corp.1988-07-18
VISULAS ND:YAG LASER (P850083/S007)Carl Zeiss, Inc.1988-07-15
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S013)General Electric Co.1988-07-15
SOFLENS(R) ENZYMATIC CONTACT LENS CLEANER (N17654/S015)Advanced Medical Optics, Inc.1988-07-15
ACTIVITRAX MODELS 8400, 8402, 8403 (P850051/S012)Medtronic, Inc.1988-07-15
87R-SA-TAB (P800069/S009)Amcon, Inc.1988-07-15
SOFT MATE(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM (P840066/S010)Advanced Medical Optics, Inc.1988-07-14
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S022)Philips Medical Systems (Cleveland), Inc.1988-07-14
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S001)3M Company1988-07-14
TESLACON(TM) NMR IMAGING SYSTEM (P830051/S015)Technicare Corp.1988-07-14
NONABSORBABLE SURG. SUTURES, BRAIDED SILK (N84348/S002)Deknatel, Inc.1988-07-14
NONABSORBABLE SURG. SUTURES, NYLON (N85060/S003)Deknatel, Inc.1988-07-14
SENSITIVE EYES CLEANING/DISINFECTING SOLUTION (P860023/S001)Bausch & Lomb, Inc.1988-07-14
DEKLENE(TM) (P810028/S006)Deknatel, Inc.1988-07-14
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S021)Philips Medical Systems (Cleveland), Inc.1988-07-14
SCIMED PTCA DILATATION CATHETER (P860019/S007)Scimed Life Systems, Inc.1988-07-12
FONAR NMR WHOLE BODY SCANNER BETA 3000 (P830076/S012)Fonar Corp.1988-07-12
HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML (P860047)Bausch & Lomb, Inc.1988-07-12
MAGNETOM (P830081/S019)Siemens Corp.1988-07-12
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Every clearance here is in the API, with alerts when new ones post.