FDA.reportPublic FDA data

AESCULAP, INC.

Matched from indexed company URL: Aesculap Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
29167142916714AESCULAP, INC.1Y2026-01-013773 CORPORATE PKWY. CENTER VALLEY PA US 18034
96802603002315844AESCULAP CHIFA SP. Z O.O.1N2026-01-01UL. TYSIACLECIA 14 NOWY TOMYSL Wielkopolskie PL 64-300
30035878963003587896AESCULAP, INC.1N2026-01-01615 LAMBERT POINTE DR. HAZELWOOD MO US 63042
30056733112916714AESCULAP IMPLANT SYSTEMS, LLC1Y2020-04-253773 CORPORATE PWKY. CENTER VALLEY PA US 18034
30057260223003587896AESCULAP IMPLANT SYSTEMS, LLC1N2020-04-25615 Lambert Pointe Dr HAZELWOOD MO US 63042
30057396253005739625AESCULAP IMPLANT SYSTEMS, LLC1N2020-04-259999 HAMILTON BLVD., BLDG 8 Breinigsville PA US 18031

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
04038653033997AESCULAP - WHITE Excavator, angled, 7" (175 mm), double ended, hexagonal handle, Fig. 20+1(800)282-9000GUDID.BBMUS_Service@bbraun.com
04038653034321AESCULAP - PLASTIC FILLING INSTRUMENT CONTRA ANGLE+1(800)282-9000GUDID.BBMUS_Service@bbraun.com
04038653034369AESCULAP - PLASTIC FILLING INSTRUMENT CONTRA ANGLE+1(800)282-9000GUDID.BBMUS_Service@bbraun.com
04038653034376AESCULAP - PLASTIC FILLING INSTRUMENT CONTRA ANGLE+1(800)282-9000GUDID.BBMUS_Service@bbraun.com
04038653034406AESCULAP - PLASTIC FILLING INSTRUMENT CONTRA ANGLE+1(800)282-9000GUDID.BBMUS_Service@bbraun.com
04038653034901AESCULAP - HOLLENBACK Finishing Instrument, angled, 6 3/4" (170 mm), double ended, hexagonal handle, Fig. 6+1(800)282-9000GUDID.BBMUS_Service@bbraun.com
04046963116194S4 CERVICAL - S4C LID US VERSION F/TRAY FW032P+1(800)282-9000GUDID.BBMUS_Service@bbraun.com
04046963794248ELAN 4 - ELAN 4 AIR 2-RING HANDPIECE L17+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
249541956886015P120024ACTIVL ARTIFICIAL DISCMJO2015-06-11
249551956886015P120024ACTIVL ARTIFICIAL DISCMJO2015-06-11
387311533105702K992218DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601GEI1999-07-30
387321533105702K992218DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601GEI1999-07-30
387311095310300K992053AESCULAP VASCULAR INSTRUMENTSDXC2000-01-13
387321095310300K992053AESCULAP VASCULAR INSTRUMENTSDXC2000-01-13
387311007212069K991088VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLEJKA1999-05-28
387321007212069K991088VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLEJKA1999-05-28
249541180997731K984124AESCULAP XENON LIGHT SOURCEFSS1999-02-01
249551180997731K984124AESCULAP XENON LIGHT SOURCEFSS1999-02-01
387312042786639K984124AESCULAP XENON LIGHT SOURCEFSS1999-02-01
387322042786639K984124AESCULAP XENON LIGHT SOURCEFSS1999-02-01
387311389241055K983758YASARGIL TITANIUM ANEURYSM CLIPSHCH1998-12-18
387321389241055K983758YASARGIL TITANIUM ANEURYSM CLIPSHCH1998-12-18
387311573602567K983365AESCULAP MINOP SYSTEMGWG1998-12-18
387321573602567K983365AESCULAP MINOP SYSTEMGWG1998-12-18
387311024479295K982914AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTSMNI1998-10-02
387321024479295K982914AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTSMNI1998-10-02
249541623311674K982914AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTSMNI1998-10-02
249551623311674K982914AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTSMNI1998-10-02
387311062122835K982623AESCULAP NEEDLESCOPIC INSTRUMENT SYSTEMGCJ1998-09-30
387321062122835K982623AESCULAP NEEDLESCOPIC INSTRUMENT SYSTEMGCJ1998-09-30
387311525399471K981645TITANIUM HEMOSTATIC CLIPFZP1998-10-13
387321525399471K981645TITANIUM HEMOSTATIC CLIPFZP1998-10-13
249541218996103K980686AESCULAP HILAN MOTOR SYSTEMHBB1998-09-02
249551218996103K980686AESCULAP HILAN MOTOR SYSTEMHBB1998-09-02
387311584843244K980686AESCULAP HILAN MOTOR SYSTEMHBB1998-09-02
387321584843244K980686AESCULAP HILAN MOTOR SYSTEMHBB1998-09-02
249541560758317K980484AESCULAP SPINE SYSTEM EVOLUTIONMNI1998-10-02
249551560758317K980484AESCULAP SPINE SYSTEM EVOLUTIONMNI1998-10-02
249541860362789K974706AESCULAP ABC CERVICAL PLATING SYSTEMKWQ1998-03-13
249551860362789K974706AESCULAP ABC CERVICAL PLATING SYSTEMKWQ1998-03-13
387312009986050K974382ACKERMANN SURGICAL INSTRUMENTSGCJ1998-04-21
387322009986050K974382ACKERMANN SURGICAL INSTRUMENTSGCJ1998-04-21
387311349818049K973736AESCULAP HILAN MOTOR SYSTEMHWE1997-12-29
387321349818049K973736AESCULAP HILAN MOTOR SYSTEMHWE1997-12-29
249541129654954K972332AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEMGXN1998-01-16
249551129654954K972332AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEMGXN1998-01-16
387311891975118K972332AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEMGXN1998-01-16
387321891975118K972332AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEMGXN1998-01-16
387311225445746K971310AESCULAP JET IRRIGATION SYSTEMGEI1997-07-18
387321225445746K971310AESCULAP JET IRRIGATION SYSTEMGEI1997-07-18
387311980057081K970851LYOPLANT DURA SUBSTITUTE(VARIOUS)GXQ1997-12-09
387321980057081K970851LYOPLANT DURA SUBSTITUTE(VARIOUS)GXQ1997-12-09
249541796751132K970549TITANIUM ALLOY BONE SCREWSHWC1997-04-30
249551796751132K970549TITANIUM ALLOY BONE SCREWSHWC1997-04-30
387311549808807K970541AESCULAP MODULAR MONOPOLAR ELECTRODESGEI1997-03-28
387321549808807K970541AESCULAP MODULAR MONOPOLAR ELECTRODESGEI1997-03-28
249541938164221K970541AESCULAP MODULAR MONOPOLAR ELECTRODESGEI1997-03-28
249551938164221K970541AESCULAP MODULAR MONOPOLAR ELECTRODESGEI1997-03-28
387311223544689K970050YASARGIL TITANIUM ANEURYSM CLIPS (FTXXXT)HCH1997-11-26
387321223544689K970050YASARGIL TITANIUM ANEURYSM CLIPS (FTXXXT)HCH1997-11-26
387311032630538K964281AESCULAP ANGLED NEUROENDOSCOPESGWG1997-04-21
387321032630538K964281AESCULAP ANGLED NEUROENDOSCOPESGWG1997-04-21
387311260348330K960470NEURO-PATCHGXQ1996-05-10
387321260348330K960470NEURO-PATCHGXQ1996-05-10
249541012854288K954652AESCULAP ENDOSCCOPIC SPINE INSTRUMENTSHRX1996-02-14
249551012854288K954652AESCULAP ENDOSCCOPIC SPINE INSTRUMENTSHRX1996-02-14
387311034411667K954652AESCULAP ENDOSCCOPIC SPINE INSTRUMENTSHRX1996-02-14
387321034411667K954652AESCULAP ENDOSCCOPIC SPINE INSTRUMENTSHRX1996-02-14
387311253257511K953968AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON)HWE1996-02-05
387321253257511K953968AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON)HWE1996-02-05
249541956641244K953720AESCULAP CASPAR PLATE & SCREW SYSTEM FOR ANTERIOR CERVICAL FUSIONKWQ1995-11-02
249551956641244K953720AESCULAP CASPAR PLATE & SCREW SYSTEM FOR ANTERIOR CERVICAL FUSIONKWQ1995-11-02
387311328441970K953446AESCULAP BIPOLAR CORDSGEI1995-09-29
387321328441970K953446AESCULAP BIPOLAR CORDSGEI1995-09-29
387311382243351K952524AESCULAP BIOPOLAR COAGULATORGEI1995-06-29
387321382243351K952524AESCULAP BIOPOLAR COAGULATORGEI1995-06-29
387311397462915K944955AESCULAP THORACOSCOPIC INSTRUMENTSKNS1994-11-09
387321397462915K944955AESCULAP THORACOSCOPIC INSTRUMENTSKNS1994-11-09
387311916985015K944864PRIMED RIGID CONTAINER SYSTEMKCT1994-12-20
387321916985015K944864PRIMED RIGID CONTAINER SYSTEMKCT1994-12-20
387311286039765K944467AESCULAP MANUAL LAPAROSCOPIC INSTRUMENTSGCJ1994-10-03
387321286039765K944467AESCULAP MANUAL LAPAROSCOPIC INSTRUMENTSGCJ1994-10-03
387311735260422K942730AESCULAP LAPAROSCOPESHET1995-04-25
387321735260422K942730AESCULAP LAPAROSCOPESHET1995-04-25
387311799137746K942053AESCULAP INTERCHANGEABLE TROCAR INSTRUMENT SETGCJ1994-06-10
387321799137746K942053AESCULAP INTERCHANGEABLE TROCAR INSTRUMENT SETGCJ1994-06-10
387311309715916K940970YASARGIL, CASPAR, VARIO CLIP APPLIERSHCI1995-01-24
387321309715916K940970YASARGIL, CASPAR, VARIO CLIP APPLIERSHCI1995-01-24
387311611466112K940936AESCULAP ENDOSCOPIC INSTRUMENTSGEI1994-04-19
387321611466112K940936AESCULAP ENDOSCOPIC INSTRUMENTSGEI1994-04-19
387311455388961K935243AESCULAP FLEXIBLE TROCAR INSTRUMENT SETGCJ1994-07-21
387321455388961K935243AESCULAP FLEXIBLE TROCAR INSTRUMENT SETGCJ1994-07-21
387311018171076K934724AESCULAP TROCAR INSTRUMENT SETFBQ1993-12-23
387321018171076K934724AESCULAP TROCAR INSTRUMENT SETFBQ1993-12-23
387311706079571K933330AESCULAP MANUAL ENDOSCOPIC INSTRUMENTSGCJ1994-06-07
387321706079571K933330AESCULAP MANUAL ENDOSCOPIC INSTRUMENTSGCJ1994-06-07
249541932001157K933330AESCULAP MANUAL ENDOSCOPIC INSTRUMENTSGCJ1994-06-07
249551932001157K933330AESCULAP MANUAL ENDOSCOPIC INSTRUMENTSGCJ1994-06-07
387311227606012K933076AESCULAP MANUAL ENDOSCOPIC INSTRUMENTSGCJ1993-09-10
387321227606012K933076AESCULAP MANUAL ENDOSCOPIC INSTRUMENTSGCJ1993-09-10
387311277565756K922797AESCULAP TROCAR INSTRUMENT SETGCJ1993-03-30
387321277565756K922797AESCULAP TROCAR INSTRUMENT SETGCJ1993-03-30
387311096448136K922576AESCULAP MANUAL ENDOSCOPIC INSTRUMENTSGEI1993-06-10
387321096448136K922576AESCULAP MANUAL ENDOSCOPIC INSTRUMENTSGEI1993-06-10
387311072610644K922272YASARGIL ANEURYSM CLIPSHCH1992-09-15
387321072610644K922272YASARGIL ANEURYSM CLIPSHCH1992-09-15
387311566193287K913765YASARGIL ANEURYSM CLIPS, MODIFICATIONHCH1992-03-11
387321566193287K913765YASARGIL ANEURYSM CLIPS, MODIFICATIONHCH1992-03-11
249541636307539K913765YASARGIL ANEURYSM CLIPS, MODIFICATIONHCH1992-03-11
387312025589734K913514ELECTROSURGICAL UNIT CABLEGEI1991-11-05
387322025589734K913514ELECTROSURGICAL UNIT CABLEGEI1991-11-05
249541819000344K913415AESCULAP TITANIUM BONE SCREWSHWC1991-10-29
249551819000344K913415AESCULAP TITANIUM BONE SCREWSHWC1991-10-29
387311871365997K900533DISPOSABLE BIPOLAR COAGULATING FORCEPSGEI1990-04-09
387321871365997K900533DISPOSABLE BIPOLAR COAGULATING FORCEPSGEI1990-04-09
387311839334227K890765STRIP, STERILIZATION INDICATOR; STEAM OR E.O. GASJOJ1989-08-07
387311788415039K890443CASPAR SCALP CLIP, APPLIERHBO1989-06-15
387321788415039K890443CASPAR SCALP CLIP, APPLIERHBO1989-06-15
387311575959068K884057ELAN-E DISPOSABLE DRAPEKKX1988-10-19
387321575959068K884057ELAN-E DISPOSABLE DRAPEKKX1988-10-19
249541585091059K880704CERULLO SUCTION REGULATORGCX1988-03-29
249551585091059K880704CERULLO SUCTION REGULATORGCX1988-03-29
387311945138848K880704CERULLO SUCTION REGULATORGCX1988-03-29
387321945138848K880704CERULLO SUCTION REGULATORGCX1988-03-29
387311847697133K833652YASARGIL FENESTRATED ANEURYSM CLIP &HCH1984-01-27
387321847697133K833652YASARGIL FENESTRATED ANEURYSM CLIP &HCH1984-01-27
387311946640825K833651CLIP APPLYING FORCEPSHCI1983-11-29
387321946640825K833651CLIP APPLYING FORCEPSHCI1983-11-29

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI492020-12-18
JWH282015-03-25
NKB272018-04-26
GCJ272018-02-20
HCH252014-01-24
JXG242024-12-16
KCT242020-03-27
KWQ222012-09-11
LZO182018-03-28
FRG142010-07-27
HCI132021-12-13
FZP132010-08-06
MNI132006-02-03
GWG102014-11-14
MQP102014-10-29
HAW102008-05-23
HBE92021-08-24
HBC82016-07-22
GXN82012-08-30
MEH82009-09-22
HRX82001-04-27
GWO62019-11-27
HBB62018-11-09
MAX62015-08-13
HWC62014-12-19
GXQ62013-06-04
HAE52023-06-29
OLO52016-05-16
HCZ42018-05-08
GZT42016-09-09
HRY42013-10-17
ODP42013-04-15
DXC42012-04-30
OVD42011-08-04
NQW42010-12-02
HRS42010-11-24
GXR42010-08-12
MAI42007-04-30
LWJ42006-08-18
KWP42002-01-30

PMA#

activL Artificial Disc

2022-06-24

AESCULAP IMPLANT SYSTEMS, LLC3773 Corporate Parkwaycenter Valley, PA 18034 PMA NumberP120024 Supplement NumberS012 Date Received06/13/2022 Decision Date06/24/2022 Product Code MJO  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason...

PMN#

AdTec

2016-05-26

AESCULAP, INC.

200 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next