데이터베이스 소개
국제 의료기기 데이터베이스 사용법
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FAQ
출처표기
Manufacturers
Aesculap Implant Systems LLC
제조사 주소
Aesculap Implant Systems LLC, 3773 Corporate Pkwy, Center Valley PA 18034-8217
제조사 모회사 (2017)
Ludwig G. Braun Gmbh U. Co. Kg
Source
USFDA
18 Events
ELAN 4 Air System 의 리콜
proSA Tool Set (Model: FV92T) 의 리콜
JS Series SterilContainer S2 의 리콜
ELAN 4 의 리콜
ELAN 4 의 리콜
ELAN 4 의 리콜
Gomco Circumcision Clamps with separate ORing 의 리콜
Device Recall Aesculap S4 Element 4.5mm Polyaxial Screws 의 리콜
Device Recall Aesculap SIBD 4 degree Trial Implant (SJ768TUS) and Aesculap SIBD 9 degree Trial Implant (SJ780TUS 의 리콜
Device Recall Aesculap S4 Cervical (S4C) Revision Instruments (FW099R and FW101R) 의 리콜
Orthopedic Template 의 리콜
Safil QUI UNDY 5/0 (1) 45CM DSMP13 의 리콜
Device Recall Strauss Penis Clamp 130MM/General Instruments 의 리콜
Device Recall DoyenCollin Mouth Gag 120MM/ General Instruments 의 리콜
Device Recall DS Titanium Ligation Clip Appliers 의 리콜
Device Recall DS Titanium Ligation Clip 의 리콜
Device Recall AESCULAP (FH620R) MINOP InVent 30 Trocar System 의 리콜
Device Recall GN200 Caiman HF generators 의 리콜
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데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 18 건
ELAN 4 Air System
모델명 / 제조번호(시리얼번호)
ELAN 4 Air System ST0607 ELAN 4 Air Control Set ST0608 ELAN 4 Air Neuro Crani Set ST0609 ELAN 4 Air Spine Set ST06411 ELAN 4 Air HD Spine Set ST0614 ELAN 4 Air Micro Saw Set ST0615 ELAN 4 Air Hand Control Set ST0638 ELAN 4 Air Large Saw Set
의료기기 분류등급
Neurological Devices
의료기기 등급
2
이식된 장치?
No
유통
Nationwide Distribution.
제품 설명
The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial Surgery.
proSA Tool Set (Model: FV92T)
모델명 / 제조번호(시리얼번호)
Batch #20034364 and #20034751
의료기기 분류등급
Neurological Devices
의료기기 등급
2
이식된 장치?
Yes
유통
US Distribution to PA.
제품 설명
proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System || Shunt, central nervous system and components
JS Series SterilContainer S2
모델명 / 제조번호(시리얼번호)
JS440 S2 1/1CONT.BOTTON PERFOR.H88MM H202 JS441 S2 1/1 CONT.BOTTOMPERFOR.H1118MM H202 JS442 S2 1/1-CONT.BOTTOM PERFOR.H133MM H202 JS444 S2 1/1 CONT.BOTTOM PEFOR.H185MM H202 JS489 S2 1/1-CONTAINER LID H202 JS740 S2 3/4 CONT.BOTTOM PERFOR.H88MMH202 JS741 S2 3/4 CONT.BOTTOM PERFOR.H118MM H202 JS742 S2 3/4 CONT.BOTTOM PERFOR.H133MM H202 JS789 S2 3/4 CONTAINER LID H202 JS340 S2 1/2 CONT.BOTTOM PERFOR.H88MM H202 JS341 S2 1/2 CONT.BOTTOM PERFOR.H118MM H202 JS342 S2 1/2 CONT.BOTTOM PERFOR.H133MM H202 JS389 S2 1/2 CONTAINER LID H202
의료기기 분류등급
General Hospital and Personal Use Devices
의료기기 등급
2
이식된 장치?
No
유통
Nationally
제품 설명
JS Series SterilContainer S2 System
ELAN 4
모델명 / 제조번호(시리얼번호)
All lots, Model Number: GP190R GP201R GP202R GP203R GP204R GP205R GP208R GP209R GP210R GP210TC GP211R GP212R GP213R GP214R GP215R GP216R GP217R GP218R GP219R GP220R GP341R GP342R GP343R GP351R GP352R GP353R GP361R GP362R GP363R GP364R GP367R GP367TC GP370R GP371R GP398SU GP399TC-SU GP491R GP492R GP493R GP494R GP495R GP496R GP497R GP542R GP543R GP544R GP545R US779R US780R US781R US782R US784TC US792R US793R US794R US795R US798TC US799TC US800R
의료기기 분류등급
Neurological Devices
의료기기 등급
2
이식된 장치?
No
유통
Distributed to 4 hospitals in the following states: NM, OH, TX, WV
제품 설명
ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 || ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5 || ELAN 4 1-RING NEURO CUTTER+ SOFT D2.0 || ELAN 4 1-RING NEURO CUTTER+ SOFT D2.5 || ELAN 4 1-RING NEURO CUTTER SOFT D3.0 || ELAN 4 1-RING NEURO CUTTER+ SOFT D3.0 || ELAN 4 1-RING NEURO CUTTER D2.0 || ELAN 4 1-RING NEURO CUTTER D2.5 || ELAN 4 1-RING NEURO CUTTER D3.0 || ELAN 4 1-RING NEURO CUTTER TC D3.0 || ELAN 4 1-RING NEURO CUTTER DIAM.D1.5 || ELAN 4 1-RING NEURO CUTTER+ DIAM.D1.5 || ELAN 4 1-RING NEURO CUTTER DIAM.D2.0 || ELAN 4 1-RING NEURO CUTTER+ DIAM.D2.0 || ELAN 4 1-RING NEURO CUTTER DIAM.D2.5 || ELAN 4 1-RING NEURO CUTTER+ DIAM.D2.5 || ELAN 4 1-RING NEURO CUTTER DIAM.D3.0 || ELAN 4 1-RING NEURO CUTTER+ DIAM.D3.0 || ELAN 4 1-RING NEURO CUTTER DIAM.D4.0 || ELAN 4 1-RING NEURO CUTTER+ DIAM.D4.0 || ELAN 4 2-RING CRANIOTOME CUTTER PAED || ELAN 4 2-RING CRANIOTOME CUTTER STANDARD || ELAN 4 2-RING CRANIOTOME CUTTER LONG ELAN 4 2-RING CRANIOTOME CUTTER PAED || ELAN 4 2-RING CRANIOTOME CUTTER STANDARD || ELAN 4 2-RING CRANIOTOME CUTTER LONG || ELAN 4 2-RING NEURO CUTTER SOFT D2,0 || ELAN 4 2-RING NEURO CUTTER SOFT D2,5 || ELAN 4 2-RING NEURO CUTTER SOFT D3,0 || ELAN 4 2-RING NEURO CUTTER+ SOFT D3,0 || ELAN 4 2-RING NEURO CUTTER SOFT D3,0 || ELAN 4 2-RING NEURO CUTTER TC D3,0 || ELAN 4 2-RING NEURO CUTTER DIAM. D3,0 || ELAN 4 2-RING NEURO CUTTER+ DIAM. D3,0 || ELAN 4 2-RING DIAMOND DISC || ELAN 4 2-RING SIDE CUTTER TC D3,0 || SAW BLADE S sagittal 11/13/0,3 || SAW BLADE S sagittal 15/5/0,3 || SAW BLADE S sagittal 20/5/0,3 || SAW BLADE S sagittal 20/10/0,3 || SAW BLADE S sagittal 20/15/0,3 || SAW BLADE S sagittal 25/5/0,3 || SAW BLADE S sagittal 25/12/0,3 || RECIPROCATING SAW BLADE MICRO 13/0.3 || RECIPROCATING SAW BLADE MICRO 20/0.3 || RECIPROCATING SAW BLADE MICRO 13/0.3 || RECIPROCATING SAW BLADE MICRO 20/0.3 || ELAN 4 1-RING NEURO CUTTER D1.5+ || ELAN 4 1-RING NEURO CUTTER D2.0+ || ELAN 4 1-RING NEURO CUTTER D2.5+ || ELAN 4 1-RING NEURO CUTTER D3.0+ || ELAN 4 1-RING SIDE CUTTING, CARBIDE D2.0 || ELAN 4 1-RING NEURO PRECISE D1.5 || ELAN 4 1-RING NEURO PRECISE D2.0 || ELAN 4 1-RING NEURO PRECISE D2.5 || ELAN 4 1-RING NEURO PRECISE D3.0 || ELAN 4 2-RING ROUND TIP FISSURE, CARBIDE D0.8 || ELAN 4 2-RING ROUND TIP FISSURE, CARBIDE D1.7 ELAN 4 NEURO PRECISE D 1.5
ELAN 4
모델명 / 제조번호(시리얼번호)
All lots, Model Number: GP188R GP189R GP344R GP345R GP346R GP347R GP348R GP349R US804R US805R US806R US828R US829R US830R
의료기기 분류등급
Neurological Devices
의료기기 등급
2
이식된 장치?
No
유통
Distributed to 4 hospitals in the following states: NM, OH, TX, WV
제품 설명
ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5 || ELAN 4 1-RING TWIST DRILL D2.0 || ELAN 4 2-RING TWIST DRILL D1,0/4,0MM || ELAN 4 2-RING TWIST DRILL D1,1/4,0MM || ELAN 4 2-RING TWIST DRILL D1,2/4,0MM || ELAN 4 2-RING TWIST DRILL D1,5/4,0MM || ELAN 4 2-RING TWIST DRILL D1,5 || ELAN 4 2-RING TWIST DRILL D2,0 || ELAN 4 2-RING WIRE PASS DRILL D1.0 || ELAN 4 2-RING WIRE PASS DRILL D1.5 || ELAN 4 2-RING WIRE PASS DRILL D2.0 || ELAN 4 2-RING WIRE PASS DRILL D1.0 || ELAN 4 2-RING WIRE PASS DRILL D1.5 || ELAN 4 2-RING WIRE PASS DRILL D2.0
하나 더 13 건 더
유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건
데이터에 대해 더 자세히 알아보기
여기
Aesculap Implant Systems LLC 3773 Corporate Pkwy Center Valley PA 18034-8217
제조사 모회사 (2017)
Ludwig G. Braun Gmbh U. Co. Kg
Source
USFDA
AESCULAP IMPLANT SYSTEMS LLC
제조사 주소
CENTER VALLEY
제조사 모회사 (2017)
Ludwig G. Braun Gmbh U. Co. Kg
Source
HC
Language
English
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