Ossur Americas Inc

FDA Filings

This page includes the latest FDA filings for Ossur Americas Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Filings

Device Company	Device	Date
GUDID 05690967648749 OSSUR AMERICAS, INC.	Power Knee PKA10003	2022-07-18
GUDID 05690967648404 OSSUR AMERICAS, INC.	Power Knee PKA10002	2021-03-22
GUDID 05690967648381 OSSUR AMERICAS, INC.	Power Knee PKA10001	2021-03-22
GUDID 05690967642839 OSSUR AMERICAS, INC.	Power Knee PKA01001T	2021-03-22
GUDID 05690967642822 OSSUR AMERICAS, INC.	Power Knee PKA01001L	2021-03-22
GUDID 05690967567590 OSSUR AMERICAS, INC.	Symbionic Leg SBL12102	2020-02-12
GUDID 05690967600679 OSSUR AMERICAS, INC.	Symbionic Leg SBL13210	2020-01-31
GUDID 05690977308633 OSSUR AMERICAS, INC.	Halo Systems 515500C	2019-03-11
GUDID 05690977308626 OSSUR AMERICAS, INC.	Halo Systems 515400C	2019-03-11
GUDID 05690977223370 OSSUR AMERICAS, INC.	Halo Systems 505500V2	2019-03-11
GUDID 05690977445260 OSSUR AMERICAS, INC.	DVT MDSDVT62204	2018-07-06
GUDID 05690977445253 OSSUR AMERICAS, INC.	DVT MDSDVT62203	2018-07-06
GUDID 05690977445246 OSSUR AMERICAS, INC.	DVT MDSDVT62201	2018-07-06
GUDID 05690977445239 OSSUR AMERICAS, INC.	DVT MDSDVT51000	2018-07-06
GUDID 05690977400863 OSSUR AMERICAS, INC.	DVT DVT55002	2018-07-06
GUDID 05690977382848 OSSUR AMERICAS, INC.	DVT DVT-SAMPLE	2018-07-06
GUDID 05690977371903 OSSUR AMERICAS, INC.	DVT DVT62204	2018-07-06
GUDID 05690977371897 OSSUR AMERICAS, INC.	DVT DVT62203	2018-07-06
GUDID 05690977371866 OSSUR AMERICAS, INC.	DVT DVT62201	2018-07-06
GUDID 05690977370524 OSSUR AMERICAS, INC.	Halo Systems 515C	2018-07-06
GUDID 05690977369344 OSSUR AMERICAS, INC.	DVT DVT67119	2018-07-06
GUDID 05690977369283 OSSUR AMERICAS, INC.	DVT DVT52000	2018-07-06
GUDID 05690977369269 OSSUR AMERICAS, INC.	DVT DVT51000	2018-07-06
GUDID 05690977368972 OSSUR AMERICAS, INC.	Halo Systems 525C	2018-07-06
GUDID 05690977368965 OSSUR AMERICAS, INC.	Halo Systems 522CS	2018-07-06
GUDID 05690977368958 OSSUR AMERICAS, INC.	Halo Systems 520V2S	2018-07-06
GUDID 05690977368941 OSSUR AMERICAS, INC.	Halo Systems 520TS	2018-07-06
GUDID 05690977368934 OSSUR AMERICAS, INC.	Halo Systems 516V2S	2018-07-06
GUDID 05690977352957 OSSUR AMERICAS, INC.	DVT DVT55001	2018-07-06
GUDID 05690977343306 OSSUR AMERICAS, INC.	Halo Systems 555CB	2018-07-06
GUDID 05690977343283 OSSUR AMERICAS, INC.	Halo Systems 554CB	2018-07-06
GUDID 05690977343269 OSSUR AMERICAS, INC.	Halo Systems 553CB	2018-07-06
GUDID 05690977334960 OSSUR AMERICAS, INC.	Halo Systems 515300T	2018-07-06
GUDID 05690977326200 OSSUR AMERICAS, INC.	Halo Systems 515500T	2018-07-06
GUDID 05690977319035 OSSUR AMERICAS, INC.	Halo Systems 515400T	2018-07-06
GUDID 05690977309357 OSSUR AMERICAS, INC.	Halo Systems 505501C	2018-07-06
GUDID 05690977309340 OSSUR AMERICAS, INC.	Halo Systems 505301C	2018-07-06
GUDID 05690977309333 OSSUR AMERICAS, INC.	Halo Systems 505401C	2018-07-06
GUDID 05690977308718 OSSUR AMERICAS, INC.	Halo Systems JT-215	2018-07-06
GUDID 05690977308701 OSSUR AMERICAS, INC.	Halo Systems JT-115	2018-07-06
GUDID 05690977308695 OSSUR AMERICAS, INC.	Halo Systems 515500V2	2018-07-06
GUDID 05690977308688 OSSUR AMERICAS, INC.	Halo Systems 515400V2	2018-07-06
GUDID 05690977308671 OSSUR AMERICAS, INC.	Halo Systems 515300V2	2018-07-06
GUDID 05690977308664 OSSUR AMERICAS, INC.	Halo Systems 515500D	2018-07-06
GUDID 05690977308657 OSSUR AMERICAS, INC.	Halo Systems 515400D	2018-07-06
GUDID 05690977308640 OSSUR AMERICAS, INC.	Halo Systems 515300D	2018-07-06
GUDID 05690977308596 OSSUR AMERICAS, INC.	Halo Systems 515300C	2018-07-06
GUDID 05690977307599 OSSUR AMERICAS, INC.	Halo Systems 531C	2018-07-06
GUDID 05690977305922 OSSUR AMERICAS, INC.	Halo Systems 505400V2	2018-07-06
GUDID 05690977305915 OSSUR AMERICAS, INC.	Halo Systems 505300V2	2018-07-06
GUDID 05690977305908 OSSUR AMERICAS, INC.	Halo Systems 505500T	2018-07-06
GUDID 05690977305892 OSSUR AMERICAS, INC.	Halo Systems 505400T	2018-07-06
GUDID 05690977305885 OSSUR AMERICAS, INC.	Halo Systems 505300T	2018-07-06
GUDID 05690977197404 OSSUR AMERICAS, INC.	Halo Systems 540D	2018-07-06
GUDID 05690977197336 OSSUR AMERICAS, INC.	Halo Systems 505500D	2018-07-06
GUDID 05690977197329 OSSUR AMERICAS, INC.	Halo Systems 505400D	2018-07-06
GUDID 05690977197312 OSSUR AMERICAS, INC.	Halo Systems 505300D	2018-07-06
GUDID 05690977197305 OSSUR AMERICAS, INC.	Halo Systems JT-210	2018-07-06
GUDID 05690977197299 OSSUR AMERICAS, INC.	Halo Systems JT-110	2018-07-06
GUDID 05690977197282 OSSUR AMERICAS, INC.	Halo Systems JT-200	2018-07-06
GUDID 05690977197275 OSSUR AMERICAS, INC.	Halo Systems JT-100	2018-07-06
GUDID 05690977196636 OSSUR AMERICAS, INC.	Halo Systems 538	2018-07-06
GUDID 05690977194090 OSSUR AMERICAS, INC.	Halo Systems 516CS	2018-07-06
GUDID 05690977193192 OSSUR AMERICAS, INC.	Halo Systems 515C4	2018-07-06
GUDID 05690977193123 OSSUR AMERICAS, INC.	Halo Systems JT-400	2018-07-06
GUDID 05690977192577 OSSUR AMERICAS, INC.	Halo Systems 517DS	2018-07-06
GUDID 05690977192348 OSSUR AMERICAS, INC.	Halo Systems 540V2	2018-07-06
GUDID 05690977165335 OSSUR AMERICAS, INC.	Halo Systems 540C	2018-07-06
GUDID 05690977164130 OSSUR AMERICAS, INC.	Halo Systems 505500C	2018-07-06
GUDID 05690977164116 OSSUR AMERICAS, INC.	Halo Systems 505400C	2018-07-06
GUDID 05690977164093 OSSUR AMERICAS, INC.	Halo Systems 505300C	2018-07-06
GUDID 05690977084544 OSSUR AMERICAS, INC.	Halo Systems 517CS	2018-07-06
GUDID 05690977084490 OSSUR AMERICAS, INC.	Halo Systems 516DS	2018-07-06
GUDID 05690977084469 OSSUR AMERICAS, INC.	Halo Systems 516TS	2018-07-06
GUDID 05690977084254 OSSUR AMERICAS, INC.	Halo Systems 522C	2018-07-06
GUDID 05690977343122 OSSUR AMERICAS, INC.	Cold Rush B-232000019	2018-06-18
GUDID 05690977343108 OSSUR AMERICAS, INC.	Cold Rush B-232000017	2018-06-18
GUDID 05690977343092 OSSUR AMERICAS, INC.	Cold Rush B-232000015	2018-06-18
GUDID 05690977279728 OSSUR AMERICAS, INC.	Rheo Knee RKN13240	2018-06-18
GUDID 05690977198593 OSSUR AMERICAS, INC.	Cold Rush B-232002404	2018-06-18
GUDID 05690977198579 OSSUR AMERICAS, INC.	Cold Rush B-232002300	2018-06-18
GUDID 05690967613136 OSSUR AMERICAS, INC.	Rheo Knee RKN13130	2018-06-18
GUDID 05690967610517 OSSUR AMERICAS, INC.	Rheo Knee RKN13140	2018-06-18
GUDID 05690967603410 OSSUR AMERICAS, INC.	Power Knee PK23100	2018-06-18
GUDID 05690967600686 OSSUR AMERICAS, INC.	Symbionic Leg SBL13211	2018-06-18
GUDID 05690967600600 OSSUR AMERICAS, INC.	Rheo Knee RKN13200	2018-06-18
GUDID 05690967600594 OSSUR AMERICAS, INC.	Rheo Knee RKN13210	2018-06-18
GUDID 05690967600587 OSSUR AMERICAS, INC.	Rheo Knee RKN13110	2018-06-18
GUDID 05690967598433 OSSUR AMERICAS, INC.	Rheo Knee RKN130005	2018-06-18
GUDID 05690967598426 OSSUR AMERICAS, INC.	Rheo Knee RKN130002	2018-06-18
GUDID 05690967596644 OSSUR AMERICAS, INC.	Rheo Knee RKN13100	2018-06-18
GUDID 05690967595425 OSSUR AMERICAS, INC.	Rheo Knee RKN130203	2018-06-18
GUDID 05690967595418 OSSUR AMERICAS, INC.	Rheo Knee RKN130003	2018-06-18
GUDID 05690967584795 OSSUR AMERICAS, INC.	Power Knee PKN120017	2018-06-18
GUDID 05690967567583 OSSUR AMERICAS, INC.	Symbionic Leg SBL12112	2018-06-18
GUDID 05690967566227 OSSUR AMERICAS, INC.	Rheo Knee RKNLPCWB1	2018-06-18
GUDID 05690967556815 OSSUR AMERICAS, INC.	Power Knee PK220007	2018-06-18
GUDID 05690967538804 OSSUR AMERICAS, INC.	Power Knee PKN12100	2018-06-18
GUDID 05690967529864 OSSUR AMERICAS, INC.	Rheo Knee RKN12100	2018-06-18
GUDID 05690967514341 OSSUR AMERICAS, INC.	Rheo Knee PRX00421	2018-06-18
PMN K130174 OSSUR AMERICAS INC	DVTCARE CA5	2013-05-02

Related Finance Registrations

NCAGE Code	34GN6	OSSUR AMERICAS, INC.
CAGE Code	34GN6	OSSUR AMERICAS, INC.
S.A.M. Registration	34GN6 [139280028]	OSSUR AMERICAS, INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092965852	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	PROSTHETIC DEVICES	3 PKG
202009231427	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	P.O. NO.120141 TWSHOULDER AIRPLANE KIT UNIHS CODE:9021.10CARRIER IS NOT LIABLE FOR THE CON TENT OF PACKING & QUANTITY IN THE PALLET.	50 CTN
202009233648	Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey	ORTHOPEDIC SOFTGOODS AND DEVICES	446 CTN
202009224827	Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey	ORTHOPEDIC SOFTGOODS AND DEVICES	446 CTN
2020092248051	Pusan,South Korea -> Los Angeles, California	4-HOLE MALE PYRAM.8MM AX OFFSET	1 CTN
2020091665784	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	PROSTHETIC DEVICES	2 PKG
2020091665784	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	PROSTHETIC DEVICES	2 PKG
202009168962	Yantian,China (Mainland) -> New York/Newark Area, Newark, New Jersey	ORTHOPEDIC SOFTGOODS AND DEVICES	446 CTN
202009147615	Vung Tau,Vietnam -> New York/Newark Area, Newark, New Jersey	METAL AIR CAM WALKER STANDARD	85 CTN