Omnilifescience Inc

FDA Filings

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

FDA Registration(s)

• Registration Number: 1226188
• FEI Number: 3008342029
• Name: OMNIlifeScience, Inc.
• Owner & Operator: OMNI Life Science, Inc.
• Contact Address: 480 Paramount Drive ; Raynham MA 02767 US
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 480 Paramount Dr ; Raynham, MA 02767 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K191765 | JWH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	KP-0455L-HP	2019-12-11
PMN K163338 | OLO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	NS-27003	2018-11-09
PMN K163338 | OLO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	NS-06752	2018-11-09
PMN K163338 | OLO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	NS-06750	2018-11-09
PMN K163338 | OLO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	KS-S1002	2018-11-09
PMN K163338 | OLO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	KS-S1002-IN	2018-11-09
PMN K163338 | OLO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	KS-S1001	2018-11-09
PMN K163338 | OLO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	KS-S1001-IN	2018-11-09
PMN K163338 | OLO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	KS-62030	2018-11-09
PMN K163338 | OLO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	9-144	2018-11-09
PMN K163338 | OLO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	4161-5400	2018-11-09
PMN K163338 | OLO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	4160-5000	2018-11-09
PMN K163338 | OLO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	4154-5100	2018-11-09
PMN K163338 | OLO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	4154-5000	2018-11-09
PMN K163338 | OLO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	4149-5000	2018-11-09
PMN K163338 | OLO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	4148-2000	2018-11-09
PMN K163338 | OLO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	4148-1005	2018-11-09
PMN K163338 | OLO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	4148-1004	2018-11-09
PMN K163338 | OLO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	4148-1002	2018-11-09
PMN K163338 | OLO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	4148-1001	2018-11-09
PMN K163338 | OLO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	4146-5300	2018-11-09
PMN K163338 | OLO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	4146-5200	2018-11-09
PMN K172467 | LZO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	OMNI ARC Anteverted Neck Hip Stem	2018-04-10
PMN K090953 | OLO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	TOTAL KNEE SURGETICS Navigation System with iBlock	2015-10-21
PMN K090953 | OLO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	1301-1020	2015-10-21
HWB OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	XH-05679	2014-11-04
HWB OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	HS-60015	2014-11-04
PMN K113242 | MEH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex ARC Hip Stem (size 0)	2012-03-21
PMN K113242 | LZO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex ARC Hip Stem (size 0)	2012-03-21
PMN K113242 | LPH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex ARC Hip Stem (size 0)	2012-03-21
PMN K113242 | KWY OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex ARC Hip Stem (size 0)	2012-03-21
PMN K112779 | LPH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex Interface Acetabular System, Acetabular Shell	2012-03-21
PMN K111193 | MEH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex ARC Hip Stem	2012-03-21
PMN K111193 | LZO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex ARC Hip Stem	2012-03-21
PMN K111193 | LPH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex ARC Hip Stem	2012-03-21
PMN K111193 | KWY OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex ARC Hip Stem	2012-03-21
PMN K111184 | MBH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex PS Knee System - PS-C Insert	2012-03-21
PMN K111184 | JWH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex PS Knee System - PS-C Insert	2012-03-21
PMN K111062 | JWH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex Knee System, Apex All Poly Tibia	2012-03-21
PMN K110947 | LZO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex K1 Hip Stem (sz 0, 1, Lat +7-12)	2012-03-21
PMN K110947 | LPH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex K1 Hip Stem (sz 0, 1, Lat +7-12)	2012-03-21
PMN K110947 | KWY OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex K1 Hip Stem (sz 0, 1, Lat +7-12)	2012-03-21
PMN K101976 | LPH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex Interface Acetabular System +4 Acetabular Insert	2012-03-21
PMN K101575 | LPH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex Modular Head Size 28, 32, 36, and 40mm (+10.5offset)	2012-03-21
PMN K101451 | LZO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex Modular Hip System BIOLOX delta Femoral Head	2012-03-21
PMN K100555 | MEH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	ApeX-LNK Poly Acetabular Liners and Apex Modular Head	2012-03-21
PMN K100555 | LZO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	ApeX-LNK Poly Acetabular Liners and Apex Modular Head	2012-03-21
PMN K100555 | LPH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	ApeX-LNK Poly Acetabular Liners and Apex Modular Head	2012-03-21
PMN K100151 | KWY OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex Hip System Bipolar Head	2012-03-21
PMN K094017 | JWH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex Knee System Tibial Baseplate Augment	2012-03-21
PMN K092443 | MEH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex Modular Interface Acetabular Cup 20 Degree Liners	2012-03-21
PMN K092443 | LZO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex Modular Interface Acetabular Cup 20 Degree Liners	2012-03-21
PMN K092443 | LPH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex Modular Interface Acetabular Cup 20 Degree Liners	2012-03-21
PMN K090845 | MEH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex ARC Hip Stem	2012-03-21
PMN K090845 | LZO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex ARC Hip Stem	2012-03-21
PMN K090845 | LPH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex ARC Hip Stem	2012-03-21
PMN K082468 | KWY OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex Hip System Bipolar Head	2012-03-21
PMN K073150 | MEH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	ApeX-LNK Poly Acetabular Inserts	2012-03-21
PMN K073150 | LZO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	ApeX-LNK Poly Acetabular Inserts	2012-03-21
PMN K073150 | LPH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	ApeX-LNK Poly Acetabular Inserts	2012-03-21
PMN K062489 | MEH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	ApeX-LNK Poly Acetabular Inserts	2012-03-21
PMN K062489 | LZO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	ApeX-LNK Poly Acetabular Inserts	2012-03-21
PMN K062489 | LPH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	ApeX-LNK Poly Acetabular Inserts	2012-03-21
PMN K112891 | MBH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex Revision Knee System	2012-03-19
PMN K112891 | JWH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex Revision Knee System	2012-03-19
KQW OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Goniometer	2012-03-13
PMN K102578 | MBH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex PS Knee System	2011-06-03
PMN K102578 | JWH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex PS Knee System	2011-06-03
HXD OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	patella clamp for resection	2011-04-27
HXD OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	cementing clamp assembly	2011-04-27
HXD OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	EAG ankle clamp, multiple	2011-04-27
HTF OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Micro curette	2011-04-27
HWP OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Tibial Punch	2011-04-11
HWP OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Modular Tibial Tray Punch	2011-04-11
HWM OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Osteotome	2011-04-11
HWM OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	K1 Osteotome	2011-04-11
HWE OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Zimmer Hudson Adapter	2011-04-11
HWE OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Zimmer Adapter	2011-04-11
HWE OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	K2 Woodpecker Adapter, short	2011-04-11
HWE OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	K1 Woodpecker Broach Adapter Assembly	2011-04-11
HWE OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Acetabular Adapter Hudson Male/Zimmer Female	2011-04-11
HTR OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Tapered Stem Rasp	2011-04-11
HTR OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	K2 Starting Rasp	2011-04-11
HTO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	K1 Trochanter Opening Tapered Reamer	2011-04-11
PMN K101994 | MBH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex Knee Modular Tibia System	2010-12-16
PMN K101994 | JWH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex Knee Modular Tibia System	2010-12-16
FSM OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	XK-05636	2010-11-30
FSM OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Mod Tibia Reamers and Stem Trials	2010-11-30
FSM OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Mod Tibia General Instruments	2010-11-30
HXC OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Torque Wrench	2010-08-11
HWR OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Offset Shell Impactor	2010-08-09
HWR OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Femoral Impactor	2010-08-09
GAD OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Hohmann Retractor	2010-08-09
GFC OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Pin Driver	2010-07-22
FZX OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Cuttng Block	2010-06-21
HWT OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	XK-60943	2010-06-10
HWT OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	XK-60942	2010-06-10
HWT OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	KS-67108	2010-06-10
HWT OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	KS-67107	2010-06-10
HWT OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	KS-67105	2010-06-10
HWT OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	A-P Block	2010-06-10
HTW OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Starter Drill	2010-06-03
HTW OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex Drill	2010-06-03
HTJ OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	XK-00055	2010-05-14
HTJ OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex Knee Instrument	2010-05-14
HTJ OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex Hip Instrument	2010-05-14
PMN K080842 | MBH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex Knee System, Model KC-240XY	2008-06-19
PMN K080842 | MBH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex Knee System, Model KC-230XY	2008-06-19
PMN K080842 | JWH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex Knee System, Model KC-240XY	2008-06-19
PMN K080842 | JWH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex Knee System, Model KC-230XY	2008-06-19
PMN K073602 | MBH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex Knee System	2008-06-19
PMN K073602 | JWH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex Knee System	2008-06-19
PMN K060192 | JWH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex Knee System	2008-06-19
PMN K060072 | LPH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex K1 Hip System	2008-06-19
PMN K043123 | MEH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex Modular Hip Stem (w & w/o HA)	2008-06-19
PMN K043123 | LZO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex Modular Hip Stem (w & w/o HA)	2008-06-19
PMN K043123 | LPH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex Modular Hip Stem (w & w/o HA)	2008-06-19
PMN K041950 | LPH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex K2 Hip System	2008-06-19
PMN K031110 | LPH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex Modular Acetabular Cup	2008-06-19
PMN K012918 | LZO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex Modular Alumina Femoral Head	2008-06-19
PMN K003923 | LZO OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Apex Modular Zirconia Femoral Head	2008-06-19
LXH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Tibial cutting block	1999-07-14
LXH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	NS-300T4-Ti	1999-07-14
LXH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	NS-300T4-SS	1999-07-14
LXH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	NS-300T4-AL	1999-07-14
LXH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	NS-300G4-Ti	1999-07-14
LXH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	NS-300G4-SS	1999-07-14
LXH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	K1 Rasping Broach	1999-07-14
LXH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	K1 Broach	1999-07-14
LXH OMNIlifeScience, Inc. [OMNI Life Science, Inc.]	Cutting Block-Headed Pin	1999-07-14