FDA 허가이력 | 위더스컨설팅

최근 당사가 진행하여 등록시킨 Class I Device 제품 코드 목록입니다. 가장 핵심적인 제품들에 대해서만 리스트 되었습니다. 이 리스트는 총 프로젝트 진행 수는 아니며 동일 제품 코드를 10건 이상 진행한 케이스들도 있습니다.

Product Code	Device Common Name	Product Code	Device Common Name
DZA	Dental Intraoral Drill	IFB	Cytocentrifuge
EAZ	Dental Operation Light	IOL, IOG	Treadmill, Powered, Mechanical
EBH	Impression Tray, Resin Material	IQI, IPX, IPY, IQK	Orthosis, Limb/Rib/Lumbo-sacral/Cervical
ECG	Orthodontic Braket Aligner	ISA, LYG	Therapeutic Massager
EFW, JEQ, MMD	Toothbrush, Manual/Powered, Ionic	ITG	Bandage, Cast
EGD	Dental Intraoral Wax	KIY	Slide Culture Chamber
EHB	X-ray Collimator	KPA	Automated Slide Stainer
EIF	Dental Retractor Accessories	KZF	Medical Examination Device
FGY	Injection Cannula	LDZ	Alcohol Containing Fixative
FNJ, INY	Bed	MCF	Ultraviolet Sanitation Sterilization
GDF	Surgical Needle	NAC	Hyrophilic Wound dressing
GFE	Dermabrasion Brush	NDP	Dental Implant Accessories
GKH	Automated blood cell diluting Apparatus	OFO	Airway Suction Kit
HTD	Forceps	PWA	Breast Pump Accessory

최근 당사가 진행하여 510(k) 허가를 받아낸 제품 코드 목록입니다. 이 리스트는 총 프로젝트 진행 수는 아니며 동일 제품 코드를 10건 이상 진행한 케이스들도 있습니다.

Product Code	Device Common Name	Product Code	Device Common Name
DZE, NHA	Dental Implant System	JEY	Dental Bone Plate
DZL	Dental Fixation Screw	KGN	Collagen Wound Dressing
DQA	Oximeter	KLE	Resin Tooth Bonding Agent
EBF	Tooth Shade Resin Material	KWP	Spinal interlaminal fixation orthosis
EHD	Extraoral X-ray System	KWQ	Spinal intervertebral body fixation orthosis
EMA	Dental Cement	LYC	Dental Bone Grafting Material
FBK	Endoscopic injection needle, Gastroenterology-urology	MAX	Spinal Intervertebral body fusion device
FCG	Biopsy Needle	MNH, MNI	Spinal Pedicle screw system
FDI	Flexible Snare	NEW	Surgical Suture
GCJ	Laparoscope	NXC	Orthodontic Aligner
GEX	Medical Laser System	ODP	Intervertebral fusion device with bone graft, cervical
HRS, HWC	Bone Fixation Plate and Screw	ONF	Powered Light Based Non-laser Surgical instrument with Thermal Effect
ILY	Infrared Lamp	OTJ	Laparoscopic Single Port Access Device