Atlas FDA

1994

432 FDA 510(k) clearances · PMA decision year

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◉ Watch 1994

RecordFirmDate
PERCUTANEUS TRANSLUMINAL CORONARY ANGIOPLASTY CATH (P940009)Scimed Life Systems, Inc.1994-09-29
CORDIS WORLDPASS PTCA DILITATION CATHETER (P880003/S028)Cordis Corp.1994-09-29
SLM-2 SILICONE UV-ABSORBING IOL (P880081/S012)Johnson & Johnson Surgical Vision, Inc.1994-09-27
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT (P890027/S022)Cochlear Americas1994-09-27
OG(R) CARDIAC PACING SYSTEM (P880006/S020)St. Jude Medical, Inc.1994-09-27
MIGHTY(TM) PTCA BALLOON DILITATION CATHETER (P840040/S046)Boston Scientific Corp1994-09-27
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S052)Cochlear Americas1994-09-27
SYNCHRONY(R) CARDIAC PACING SYSTEM (P880086/S027)ABBOTT MEDICAL1994-09-27
AFP CARDIAC PACING SYSTEM (P830045/S046)St. Jude Medical, Inc.1994-09-27
SCIMED(R) PTCA CATHETER (P860019/S091)Scimed Life Systems, Inc.1994-09-27
ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S010)Abiomed Cardiovascular, Inc.1994-09-23
SCIMED(R) INDY(TM) PTCA CATHETER (P860019/S087)Scimed Life Systems, Inc.1994-09-22
KABI PHARMACIA ONE PIECE LENSES (P810055/S051)Advanced Medical Optics, Inc.1994-09-20
GEMNOS TC 04 PULSE GENERATOR & SOFTWARE MODULE (P820076/S016)Biotronik, Inc.1994-09-19
PHACO-FLEX(TM) MODELS SI-18B & SI-18NB IOL (P880081/S011)Johnson & Johnson Surgical Vision, Inc.1994-09-19
ABBOTT IMX(R) PSA* (P910007/S001)Abbott Laboratories1994-09-13
SCIMED(R) PTCA CATHETER (P860019/S085)Scimed Life Systems, Inc.1994-09-13
ENDOTAK(R) CLEAD SYSTEM (P910073/S002)Boston Scientific1994-09-13
DORNIER LITHOTRIPTER COMPACT (P840008/S047)Dornier Medtech America, Inc.1994-09-12
IMX(R) HAVAB (P780012/S007)Abbott Laboratories1994-09-12
SCIMED(R) PTCA CATHETER (P860019/S090)Scimed Life Systems, Inc.1994-09-12
HAVAB-M DIAGNOSTIC KIT (P790019/S005)Abbott Laboratories1994-09-12
SOFT MATE SALINE SOLUTION / SENSITIVE EYES (N17908/S045)Alcon Laboratories1994-09-09
SOFTWARE(R) PLUS (P880079/S012)Ciba Vision Corporation1994-09-09
AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH) (P800002/S010)C.R. Bard, Inc.1994-09-09
ULTRA CARE (TM) NEUTRALIZING TABLET (P850088/S031)Advanced Medical Optics, Inc.1994-09-09
MEDTRONIC DUAL CHAMBER PACEMAKERS (P890003/S030)Medtronic, Inc.1994-09-06
MEDTRONIC SINGLE CHAMBER PACEMAKERS (P850051/S044)Medtronic, Inc.1994-09-06
MODEL LI30U SOFLEX(TM) UV-ABSORB. INTRAOCULAR LENS (P910061)Bausch & Lomb1994-09-02
SYNCHROMED PUMPS (P860004/S031)Medtronic, Inc.1994-09-01
SYNCHRONY(R) CARDIAC PACING SYSTEM (P880086/S025)ABBOTT MEDICAL1994-08-30
MEDTRONIC(R) EVERGREEN(TM) COR.BALL.DIL. CATH. (P870036/S030)Medtronics Interventional Vascular1994-08-30
SYNCHROMED INFUSION SYS. MODEL 8551 REFILL KIT (P860004/S027)Medtronic, Inc.1994-08-30
MEDTRONIC SYNCHROMED INFUSION SYSTEM (P860004/S032)Medtronic, Inc.1994-08-30
ELASTIC LENS(TM) AA-4203 & CHIROFLEX(TM) 32-C10XX (P880091/S004)Staar Surgical Co.1994-08-30
REFLEX MODEL 8223E (P820018/S064)St. Jude Medical, Inc.1994-08-30
MEDTRONIC(R) PANTHER (TM) 40 COR..BALL. DIL. CATH. (P870036/S029)Medtronics Interventional Vascular1994-08-30
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S059)Biomerieux Vitek, Inc.1994-08-30
SCIMED(R) NC COBRA(TM) 14 PTCA CATHETER (P860019/S089)Scimed Life Systems, Inc.1994-08-29
SCIMED(R) PTCA CATHETER (P860019/S086)Scimed Life Systems, Inc.1994-08-25
ONE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES (P840039/S040)Bausch & Lomb, Inc.1994-08-25
ONE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES (P860002/S012)Bausch & Lomb1994-08-25
HYBRITECH(R) TANDEM (R) PSA ASSAY IMMUNOMETRIC (P850048/S009)Beckman Coulter, Inc.1994-08-25
NEW JERSEY LCS(R) TOTAL KNEE SYSTEM (P830055/S036)Depuy, Inc.1994-08-23
CM(TM) LENSES (P810055/S053)Advanced Medical Optics, Inc.1994-08-23
NEW JERSEY LCS(R) UNICOMPARTMENTAL KNEE (P910016/S004)Depuy, Inc.1994-08-23
HYBRID (PTCA) CATHETER (P850021/S028)Abbott Vascular, Inc.1994-08-19
GORE-TEX(R) SUTURE (P820083/S017)W. L. Gore & Associates, Inc.1994-08-19
QRAKSTAR 14 PTCA CATHETERS (P880003/S026)Cordis Corp.1994-08-18
PROVISC TM VISCOELASTIC PREPARATION (P890047/S002)Alcon Research, Ltd.1994-08-17
VISCOAT(TM) (P840064/S011)Alcon Laboratories1994-08-17
BOSTON LENS(R) CLEANER (P820069/S013)Polymer Technology Corp.1994-08-15
MEDTRONIC MODEL 9751C SYS. ENHANCEMENT MODULE (P820003/S068)Medtronic Cardiac Rhythm Disease Management1994-08-15
H55 HYDROPHILIC CONTACT LENS (P890023/S002)The Cooper Companies1994-08-15
THE BOSTON TM CLEANER II (P890054/S001)Polymer Technology Corp.1994-08-15
UV/ABSORBING POSTERIOR CHAMBER IOL (P860059/S070)Advanced Medical Optics, Inc.1994-08-15
MICROFIBRILLAR COLLAGEN HEMOSTAT (N17600/S010)Davol Inc., Sub. C. R. Bard, Inc.1994-08-12
TRAKSTAR 18 PTCA CATHETERS (P880003/S027)Cordis Corp.1994-08-12
ZIMMER DOUGH TYPE & L.V.C.(R) BONE CEMENT (N17755/S043)Zimmer, Inc.1994-08-12
CHIROFLEX(TM) MODEL 32-C10XX SILICONE POS.CHA.IOL (P910058/S005)Bausch & Lomb, Inc.1994-08-11
POSTERIOR CHAMBER INTRAOCULAR LENSES MODEL CM21U (P870045/S035)Bausch & Lomb, Inc.1994-08-11
GORE-TEX(R) SUTURE (P820083/S018)W. L. Gore & Associates, Inc.1994-08-11
NEW JERSEY LCS(R) TOTAL KNEE SYSTEM (P830055/S032)Depuy, Inc.1994-08-10
NEW JERSEY LCS(R) TOTAL KNEE SYSTEM (P830055/S033)Depuy, Inc.1994-08-10
MODELS PC-52ANB,PC-53ANB,PC-53ATB,PC-54ANB IOL'S (P820049/S058)Advanced Medical Optics, Inc.1994-08-09
COOK BIRD'S NEST VENA CAVA FILTER (P850049/S004)Cook, Inc.1994-08-09
ONE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES (P860002/S013)Bausch & Lomb1994-08-09
ONE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES (P840039/S041)Bausch & Lomb, Inc.1994-08-09
ANTERIOR CHAMBER INTRAOCULAR LENSES (P880090/S011)Bausch & Lomb, Inc.1994-08-09
ONE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES (P870073/S013)Bausch & Lomb, Inc.1994-08-09
VENTAK MODELS 1550 AND 1555 (P830060/S034)Boston Scientific1994-08-08
INTERPORE PRO OSTEAN(R)IMPLANT 500 COR. HYDROX (P860005/S004)Interpore Intl.1994-08-08
VENTAK(R) P MODEL 1600 (P890061/S008)Boston Scientific1994-08-08
ENDOTAK(R) C LEAD, MODELS 0070, 0072,0074 (P910073/S001)Boston Scientific1994-08-05
UV/ABSORBING POSTERIOR CHAMBER IOL MODEL UPB330GS (P860059/S073)Advanced Medical Optics, Inc.1994-08-05
UV/ABSORBING POSTERIOR CHAMBER IOL MODEL UPB330FS (P860059/S074)Advanced Medical Optics, Inc.1994-08-05
MODEL PC-42ANB POSTERIOR IOL (P820049/S056)Advanced Medical Optics, Inc.1994-08-04
SYNCHROMED MODEL 8820 PROGRAMMER (ALTERNATE) (P860004/S028)Medtronic, Inc.1994-08-04
ACS RX ELIPSE(TM) .014 CORNARY DILITATION CATH. (P810046/S149)Advanced Cardiovascular Systems, Inc.1994-08-04
LEOCOR CORFLO(TM) MODEL 7.5PT & PICO-ST COATED CAT (P890001/S010)Leocor, Inc.1994-08-04
PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT (P900043)Cordis Corp.1994-08-02
CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM (P910023/S001)ABBOTT MEDICAL1994-07-29
ANTERIOR CHAMBER INTRAOCULAR LENSES MODEL 121UV (P880090/S015)Bausch & Lomb, Inc.1994-07-29
ONE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES (P860002/S015)Bausch & Lomb1994-07-29
AORTIC VALVED GRAFT WITH MEADOX(R) HEMASHIELD(R) (P810002/S032)ABBOTT MEDICAL1994-07-29
CHIROFLEX(TM) ADD MODEL 32-C11XX SINGLE PIECE IOL (P910058/S003)Bausch & Lomb, Inc.1994-07-29
CHIROFLEX(TM) SINGLE PIECE SILICONE POST. CHAM.IOL (P910058/S002)Bausch & Lomb, Inc.1994-07-29
ONE PIECE POSTERIOR CHAMBER INTRAOCULAR LENS (P840039/S046)Bausch & Lomb, Inc.1994-07-29
MODEL KR10UV,THREE PIECE IOL/W PMMA HAPTICS (P870073/S015)Bausch & Lomb, Inc.1994-07-29
MODEL AA-4203F SINGLE PIECE IOL (P880091/S003)Staar Surgical Co.1994-07-29
MODEL JM19UB POSTERIOR CHAMBER IOL (P870045/S033)Bausch & Lomb, Inc.1994-07-28
LEOCOR PICO RUNNER CATHETER (P890001/S009)Leocor, Inc.1994-07-28
DORNIER MFL5000 MOBILE LITHOTRIPTER (P840008/S049)Dornier Medtech America, Inc.1994-07-27
SYNERGY(TM) CONVERTIBLE RAPID EXCHANGE PTCA CATH (P840040/S044)Boston Scientific Corp1994-07-26
ALTERNATE STERILIZATION /VISTA(TM)T PRODUCTS (P840068/S017)Boston Scientific1994-07-26
MEDTRONIC(R)SPIRIT(TM)30 & 40 COR.BALL. DIL. CATH. (P870036/S028)Medtronics Interventional Vascular1994-07-26
HYBRID (PTCA) CATHETER (P850021/S026)Abbott Vascular, Inc.1994-07-26
HYBRID (PTCA) CATHETER (P850021/S025)Abbott Vascular, Inc.1994-07-26
ULTRA CARE (TM) NEUTRALIZING TABLET (P850088/S030)Advanced Medical Optics, Inc.1994-07-22
VASCUTEK GELSEAL(TM) VASCULAR GRAFT (P890045/S006)Carbomedics, Inc.1994-07-22
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Track 1994 automatically

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