Otto Bock Scandinavia Ab

FDA Filings

This page includes the latest FDA filings for Otto Bock Scandinavia Ab. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 9616041
• FEI Number: 1000470576
• Name: OTTO BOCK SCANDINAVIA AB
• Owner & Operator: Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar
• Contact Address: Max-Nader-Strasse 15 ; Duderstadt DE-NI Niedersachsen 37115 DE
• US Agent:
  • Angie Zhang
  • Ottobock
  • 512 8062814
  • Angie.Zhang@ottobock.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: KOPPARGATAN 3 ; NORRKOPING Ostergotlands lan [SE-05], 602 23 SE
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
IMP OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	VARIOUS MODELS	2013-12-16
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Wristoform	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Wrist Support	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Wrist Support Child	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Wrist Support Basic line	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	VARIOUS MODELS	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Toe Pick-up Ank.Jt.-Child	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Thumboform X-long	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Thumboform Short	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Thumboform Long	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	System Positioning Joint	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Standard contour ankle joint (pair)	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Stainless Steel Elbow Joint Bars	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Stainl.Steel Polycentr. Elbow Joint Bars	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Stainl.Steel Elb. Joint Bar w.Cable Lock	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Shouldersupport	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Rhizo Forsa, Thumborthosis	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Rehband Thigh Support	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Rehband Calf support	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Rehband Calf support, CL	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Rehband Calf support Women, CL	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	RX Shin & Calf Sleeve	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	QD Thigh Support	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	QD Shin & Calf Sleeve	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	QD Shin & Calf Sleeve 3mm Black	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Omo Neurexa	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Manu Sensa wrist support, skin color	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Manu Rheuma Pollex	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Manu Rheuma Flex	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Manu Junior	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Manu Direxa Basic	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Manu Direxa Basic W&T	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Manu ComforT	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Manu ComforT Stable	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Manu Carezza	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Manu Arexa	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Manu Arexa Pollex	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Malleo Immobil Walker, low	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Malleo Immobil Air Walker, low	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Malleo Immobil Air Walker, high	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Lim Mot Ankle Jt for Child	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Knee Support Basic line	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Flexible Joint Splints	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Epiflex	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Epi Support Basic line	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Epi Sensa	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Epi Forsa Plus	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Elbowsupport Hyper-Ex	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Double action Ankle Joints (pair)	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Double Bar Ankle Joint	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Double Act. Ankle Jt.Child	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Diagonal Comfort	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Calf Support Basic line	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	C-Brace	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Below-Elbow Harness	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Arm bar with elbow joint	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Ankle Support Basic line	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Ankle Joint	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Ankle Joint for Children	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Ankle Joint -Stainl.Steel-	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Ankle Foot Orthosis	2005-09-26
IQI OTTO BOCK SCANDINAVIA AB [Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcar]	Acro ComforT	2005-09-26

Related Finance Registrations

NCAGE Code	A343N	OTTO BOCK SCANDINAVIA AB
NCAGE Code	SHE39	OTTO BOCK SCANDINAVIA AB
CAGE Code	SHE39	OTTO BOCK SCANDINAVIA AB
CAGE Code	A343N	OTTO BOCK SCANDINAVIA AB