Exact Medical Manufacturing Inc

FDA Filings

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

FDA Registration(s)
Registration Number3008011779
FEI Number3008011779
NameEXACT MEDICAL MANUFACTURING, INC.
Owner & OperatorExact Medical Manufacturing, Inc.
Contact Address4917 William Street - Suite C
Lancaster NY 14086 US
Official Correspondent
  • Ryan Power
  • x-716-6810866-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address4917 William Street - Suite C
Lancaster, NY 14086 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number3013443304
FEI Number3013443304
NameRyan Power
Owner & OperatorExact Medical Manufacturing, Inc.
Contact Address21# Qingjiang Road
Changzhou CN-32 Jiangsu 213022 CN
Official Correspondent
  • Ryan Power
  • 86-137-75063785-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4917 William St
Lancaster, NY 14086 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Complaint File Establishment per 21 CFR 820.198
  • Export Device to the United States But Perform No Other Operation on Device



FDA Filings

Device
Company
DeviceDate
EXACT MEDICAL MANUFACTURING, INC.
Exact Medical Manufacturing HemviewCSD1001S2024-04-04
EXACT MEDICAL MANUFACTURING, INC.
Exact Medical Manufacturing HemviewCSD1003S2024-04-04
EXACT MEDICAL MANUFACTURING, INC.
Exact Medical Manufacturing 2024-04-04
EXACT MEDICAL MANUFACTURING, INC.
Exact Medical 2024-03-27
EXACT MEDICAL MANUFACTURING, INC.
3M 70-2011-8757-52023-12-26
EXACT MEDICAL MANUFACTURING, INC.
3M 70-2011-8756-72023-12-26
EXACT MEDICAL MANUFACTURING, INC.
3M 70-2011-8754-22023-12-26
EXACT MEDICAL MANUFACTURING, INC.
3M 70-2011-8752-62023-12-26
EXACT MEDICAL MANUFACTURING, INC.
3M 70-2011-8750-02023-12-26
EXACT MEDICAL MANUFACTURING, INC.
3M 70-2011-8758-32023-12-26
EXACT MEDICAL MANUFACTURING, INC.
Exact Medical Manufacturing HemviewCSD1001S2023-11-20
EXACT MEDICAL MANUFACTURING, INC.
Clever Medical 915122023-11-10
EXACT MEDICAL MANUFACTURING, INC.
Icon Surgical MDIC54541502023-11-08
EXACT MEDICAL MANUFACTURING, INC.
Exact Medical Manufacturing 11718EU2023-11-08
EXACT MEDICAL MANUFACTURING, INC.
Exact Medical Manufacturing E21782023-11-08
EXACT MEDICAL MANUFACTURING, INC.
Exact Medical Manufacturing E21842023-11-08
EXACT MEDICAL MANUFACTURING, INC.
Exact Medical Manufacturing E21832023-11-08
EXACT MEDICAL MANUFACTURING, INC.
Operating Room Innovations ORI-SDL-LEAD2023-10-25
EXACT MEDICAL MANUFACTURING, INC.
Flex Operating Room, LLC 2023-10-04
EXACT MEDICAL MANUFACTURING, INC.
Flex Operating Room, LLC 2023-10-04
EXACT MEDICAL MANUFACTURING, INC.
Operating Room Innovations 2023-09-06
EXACT MEDICAL MANUFACTURING, INC.
Surgical One D0614-HC2023-08-30
EXACT MEDICAL MANUFACTURING, INC.
Globus Medical, Inc. 6203.2011S2023-08-17
EXACT MEDICAL MANUFACTURING, INC.
Globus Medical, Inc. 6203.2010S2023-08-17
EXACT MEDICAL MANUFACTURING, INC.
Microport Navibot (Suzhou) Co., Ltd. 214200022023-08-17
EXACT MEDICAL MANUFACTURING, INC.
Exact Medical Manufacturing E64592023-08-17
EXACT MEDICAL MANUFACTURING, INC.
Exact Medical Manufacturing E64582023-08-17
EXACT MEDICAL MANUFACTURING, INC.
Globus Medical, Inc. 6221.2070S2023-08-17
EXACT MEDICAL MANUFACTURING, INC.
Exact Medical Manufacturing 2023-06-23
EXACT MEDICAL MANUFACTURING, INC.
Austin Medical 2023-06-16
EXACT MEDICAL MANUFACTURING, INC.
Austin Medical 2023-06-16
EXACT MEDICAL MANUFACTURING, INC.
Bausch Lomb 2023-05-29
EXACT MEDICAL MANUFACTURING, INC.
Exact Medical Manufacturing, Inc. 2023-05-02
EXACT MEDICAL MANUFACTURING, INC.
Exact Medical Manufacturing, Inc 2023-04-25
EXACT MEDICAL MANUFACTURING, INC.
Exact Medical Manufacturing, Inc 2023-04-25
EXACT MEDICAL MANUFACTURING, INC.
Exact Medical Manufacturing, Inc 2023-04-25
EXACT MEDICAL MANUFACTURING, INC.
AngioDynamics 106010062023-04-13
EXACT MEDICAL MANUFACTURING, INC.
Egg Medical, Inc. EN-SD-0012023-04-13
EXACT MEDICAL MANUFACTURING, INC.
Austin Medical HemviewCSD1001S2023-04-13
EXACT MEDICAL MANUFACTURING, INC.
Americare AMC-E64482023-04-13
EXACT MEDICAL MANUFACTURING, INC.
Americare AMC-E6434A2023-04-13
EXACT MEDICAL MANUFACTURING, INC.
Americare AMC-E55132023-04-13
EXACT MEDICAL MANUFACTURING, INC.
Americare AMC-E55122023-04-13
EXACT MEDICAL MANUFACTURING, INC.
Americare AMC-E50022023-04-13
EXACT MEDICAL MANUFACTURING, INC.
Americare AMC-A70112023-04-13
EXACT MEDICAL MANUFACTURING, INC.
Americare AMC-A70052023-04-13
EXACT MEDICAL MANUFACTURING, INC.
Americare AMC-A60032023-04-13
EXACT MEDICAL MANUFACTURING, INC.
Americare AMC-A50022023-04-13
EXACT MEDICAL MANUFACTURING, INC.
Surgical One D5910-18U2023-04-13
EXACT MEDICAL MANUFACTURING, INC.
JohnMark International, Inc. JMI-BTSD-UNI0012023-04-13
EXACT MEDICAL MANUFACTURING, INC.
Future Generation Medical FGM-D07262023-04-13
EXACT MEDICAL MANUFACTURING, INC.
SchureMed 800-0281 2023-04-13
EXACT MEDICAL MANUFACTURING, INC.
Future Generation Medical FGM-D01192023-04-13
EXACT MEDICAL MANUFACTURING, INC.
Future Generation Medical FGM-D08242023-04-13
EXACT MEDICAL MANUFACTURING, INC.
Future Generation Medical FGM-D03152023-04-13
EXACT MEDICAL MANUFACTURING, INC.
Future Generation Medical FGM-D19892023-04-13
EXACT MEDICAL MANUFACTURING, INC.
Surgical One D54502023-04-13
EXACT MEDICAL MANUFACTURING, INC.
Surgical One D5920-622023-04-13
EXACT MEDICAL MANUFACTURING, INC.
Surgical One DR6502023-04-13
EXACT MEDICAL MANUFACTURING, INC.
Surgical One DR6512023-04-13
EXACT MEDICAL MANUFACTURING, INC.
Future Generation Medical FGM-D18472023-04-13
EXACT MEDICAL MANUFACTURING, INC.
Exact Medical Manufacturing ProbeCoverPolyurethane-L-12023-04-13
EXACT MEDICAL MANUFACTURING, INC.
Exact Medical Manufacturing ProbeCoverPolyurethane-H-12023-04-13
EXACT MEDICAL MANUFACTURING, INC.
Surgical One DR6522023-04-13
EXACT MEDICAL MANUFACTURING, INC.
Vet Surgical 32202023-04-12
EXACT MEDICAL MANUFACTURING, INC.
Heartland Medical 268702023-04-12
EXACT MEDICAL MANUFACTURING, INC.
Tecfen Medical QDR10612023-04-12
EXACT MEDICAL MANUFACTURING, INC.
Coulmed Products Group DI-14162023-04-12
EXACT MEDICAL MANUFACTURING, INC.
Coulmed Products Group DI-14152023-04-12
EXACT MEDICAL MANUFACTURING, INC.
Surgical One D44032023-04-12
EXACT MEDICAL MANUFACTURING, INC.
Surgical One D44022023-04-12
EXACT MEDICAL MANUFACTURING, INC.
Xact XR-PDR-DRP2023-04-12
EXACT MEDICAL MANUFACTURING, INC.
American Surgical Specialties AM30452023-04-12
EXACT MEDICAL MANUFACTURING, INC.
Austin HemviewCSD02A2023-04-12
EXACT MEDICAL MANUFACTURING, INC.
Surgical One D44292023-04-12
EXACT MEDICAL MANUFACTURING, INC.
Austin A-AU-TT1-SC2023-04-12
EXACT MEDICAL MANUFACTURING, INC.
GTKS Medical C5512G2023-04-12
EXACT MEDICAL MANUFACTURING, INC.
GTKS Medical C5513G2023-04-12
EXACT MEDICAL MANUFACTURING, INC.
GTKS Medical C5509G2023-04-12
EXACT MEDICAL MANUFACTURING, INC.
MakoMed MM30022023-04-12
EXACT MEDICAL MANUFACTURING, INC.
MakoMed MM30012023-04-12
EXACT MEDICAL MANUFACTURING, INC.
MakoMed MM30002023-04-12
EXACT MEDICAL MANUFACTURING, INC.
MakoMed MM20012023-04-12
EXACT MEDICAL MANUFACTURING, INC.
MakoMed MM20002023-04-12
EXACT MEDICAL MANUFACTURING, INC.
MakoMed MM10022023-04-12
EXACT MEDICAL MANUFACTURING, INC.
MakoMed MM10012023-04-12
EXACT MEDICAL MANUFACTURING, INC.
MakoMed MM10002023-04-12
EXACT MEDICAL MANUFACTURING, INC.
Surgical One D0614-HC2023-04-12
EXACT MEDICAL MANUFACTURING, INC.
Xact ASA0390182023-04-12
EXACT MEDICAL MANUFACTURING, INC.
Artromed AM30082023-04-12
EXACT MEDICAL MANUFACTURING, INC.
Prescott DE5601G2023-04-12
EXACT MEDICAL MANUFACTURING, INC.
Prescott DE5705G2023-04-12
EXACT MEDICAL MANUFACTURING, INC.
Prescott DE5715G2023-04-12
EXACT MEDICAL MANUFACTURING, INC.
Prescott DE5707G2023-04-12
EXACT MEDICAL MANUFACTURING, INC.
Prescott DE5513G2023-04-12
EXACT MEDICAL MANUFACTURING, INC.
Exact Medical Manufacturing 11718EU2023-04-12
EXACT MEDICAL MANUFACTURING, INC.
Exact Medical Manufacturing E21832023-04-12
EXACT MEDICAL MANUFACTURING, INC.
Exact Medical Manufacturing E21842023-04-12
EXACT MEDICAL MANUFACTURING, INC.
Cone Instruments 1114602023-04-12
EXACT MEDICAL MANUFACTURING, INC.
Vet Surgical 32052023-04-12
Ryan Power [Exact Medical Manufacturing, Inc.]
Kit, Convenience2019-09-12
EXACT MEDICAL MANUFACTURING, INC.
Kit, Convenience2019-09-12
Ryan Power [Exact Medical Manufacturing, Inc.]
Dark Drape2018-12-14
Ryan Power [Exact Medical Manufacturing, Inc.]
Transport Pad2018-04-02
Ryan Power [Exact Medical Manufacturing, Inc.]
Tauro Towel2018-04-02
Ryan Power [Exact Medical Manufacturing, Inc.]
Scope Transport Pad2018-04-02
Ryan Power [Exact Medical Manufacturing, Inc.]
Mayo Cover2018-04-02
Ryan Power [Exact Medical Manufacturing, Inc.]
Film Table Cover2018-04-02
Ryan Power [Exact Medical Manufacturing, Inc.]
BTC (Back Table Cover)2018-04-02
EXACT MEDICAL MANUFACTURING, INC.
Transport Pad2018-04-02
EXACT MEDICAL MANUFACTURING, INC.
Tauro Towel2018-04-02
EXACT MEDICAL MANUFACTURING, INC.
Scope Transport Pad2018-04-02
EXACT MEDICAL MANUFACTURING, INC.
Mayo Cover2018-04-02
EXACT MEDICAL MANUFACTURING, INC.
Film Table Cover2018-04-02
EXACT MEDICAL MANUFACTURING, INC.
BTC (Back Table Cover)2018-04-02
Ryan Power [Exact Medical Manufacturing, Inc.]
34"x24" Paper Filter w/ Foam Gasket2017-12-06
EXACT MEDICAL MANUFACTURING, INC.
34"x24" Paper Filter w/ Foam Gasket2017-12-06
Ryan Power [Exact Medical Manufacturing, Inc.]
Z-Friction Drape2017-08-31
Ryan Power [Exact Medical Manufacturing, Inc.]
Anti-Fog Scope Warmer2017-08-31
Ryan Power [Exact Medical Manufacturing, Inc.]
Standard Face Shield2017-08-31
Ryan Power [Exact Medical Manufacturing, Inc.]
Self Donning Tabs2017-08-31
Ryan Power [Exact Medical Manufacturing, Inc.]
ORI Drop Stop Kit2017-08-31
Ryan Power [Exact Medical Manufacturing, Inc.]
FaceDrape2017-08-31
Ryan Power [Exact Medical Manufacturing, Inc.]
FaceDrape, Wide2017-08-31
Ryan Power [Exact Medical Manufacturing, Inc.]
Face Shield2017-08-31
Ryan Power [Exact Medical Manufacturing, Inc.]
Face Shield, attached with Full Covering2017-08-31
Ryan Power [Exact Medical Manufacturing, Inc.]
Face Shield 9"long x 13" Wide w/ Drape - 13"x13"2017-08-31
Ryan Power [Exact Medical Manufacturing, Inc.]
Compression Garment2017-08-31
Ryan Power [Exact Medical Manufacturing, Inc.]
Ice Pack2017-08-31
Ryan Power [Exact Medical Manufacturing, Inc.]
Ice Compression Bandage2017-08-31
Ryan Power [Exact Medical Manufacturing, Inc.]
SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV2017-01-25
Ryan Power [Exact Medical Manufacturing, Inc.]
EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV2017-01-25
Ryan Power [Exact Medical Manufacturing, Inc.]
EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER2017-01-25
Ryan Power [Exact Medical Manufacturing, Inc.]
EMM EQUIPMENT COVER-POLYTHYLENE2017-01-25
Ryan Power [Exact Medical Manufacturing, Inc.]
EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES2017-01-25
Ryan Power [Exact Medical Manufacturing, Inc.]
EMM SURGICAL DRAPE SMS W/PE SIDES2017-01-25
Ryan Power [Exact Medical Manufacturing, Inc.]
EMM SURGICAL GOWN-SMS WITH PE LAYER2017-01-25
EXACT MEDICAL MANUFACTURING, INC.
Self Donning Tabs2016-01-22
EXACT MEDICAL MANUFACTURING, INC.
ORI Drop Stop Kit2016-01-22
EXACT MEDICAL MANUFACTURING, INC.
FaceDrape2016-01-22
EXACT MEDICAL MANUFACTURING, INC.
FaceDrape, Wide2016-01-22
EXACT MEDICAL MANUFACTURING, INC.
Face Shield2016-01-22
EXACT MEDICAL MANUFACTURING, INC.
Face Shield, attached with Full Covering2016-01-22
EXACT MEDICAL MANUFACTURING, INC.
Face Shield 9" long x 13" wide w/ Drape- 13"x13"2016-01-22
EXACT MEDICAL MANUFACTURING, INC.
Compression Garment2016-01-22
EXACT MEDICAL MANUFACTURING, INC.
Ice Pack2016-01-22
EXACT MEDICAL MANUFACTURING, INC.
Ice Compression Bandage2016-01-22
EXACT MEDICAL MANUFACTURING, INC.
Z-Friction Drape2016-01-18
EXACT MEDICAL MANUFACTURING, INC.
Anti-fog Scope Warmer2016-01-18
EXACT MEDICAL MANUFACTURING, INC.
Transport Pad2015-10-29
EXACT MEDICAL MANUFACTURING, INC.
Surgical Drape with Liquid Barrier Level IV2013-08-14
EXACT MEDICAL MANUFACTURING, INC
SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV2013-02-14
EXACT MEDICAL MANUFACTURING, INC.
Surgical Gown with AAMI Liquid Barrier Level IV2012-06-19
EXACT MEDICAL MANUFACTURING, INC.
EMM High Performance Surgical Gown with AAMI Liquid Barrier Level IV2012-06-19
EXACT MEDICAL MANUFACTURING, INC
EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV2012-06-12
EXACT MEDICAL MANUFACTURING, INC.
Spunlace Surgical Gown2011-09-19
EXACT MEDICAL MANUFACTURING, INC.
Gown, Surgical Spunlace2011-09-19
EXACT MEDICAL MANUFACTURING, INC.
Gown, Surgical Spun2011-09-19
EXACT MEDICAL MANUFACTURING, INC.
EMM Surgical Gown-Spunlace w/PE layer2011-09-19
EXACT MEDICAL MANUFACTURING, INC
EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER2011-08-26
EXACT MEDICAL MANUFACTURING, INC.
Surgical Drape, Spunlace2010-11-02
EXACT MEDICAL MANUFACTURING, INC.
Surgical Drape, Spun2010-11-02
EXACT MEDICAL MANUFACTURING, INC.
Spunlace Surgical Drape2010-11-02
EXACT MEDICAL MANUFACTURING, INC.
EMM Surgical Drape-Spunlace w/PE sides model 13-0042010-11-02
EXACT MEDICAL MANUFACTURING, INC.
Table Cover2010-10-28
EXACT MEDICAL MANUFACTURING, INC.
Equipment Cover2010-10-28
EXACT MEDICAL MANUFACTURING, INC.
EMM Equipment Cover-Polyethylene2010-10-28
EXACT MEDICAL MANUFACTURING, INC.
Back Table Cover2010-10-28
EXACT MEDICAL MANUFACTURING, INC.
BTC2010-10-28
EXACT MEDICAL MANUFACTURING, INC.
Surgical Drape, SMS2010-10-28
EXACT MEDICAL MANUFACTURING, INC.
SMS Surgical Drape2010-10-28
EXACT MEDICAL MANUFACTURING, INC.
EMM Surgical Drape SMS w/PE sides model 13-0052010-10-28
EXACT MEDICAL MANUFACTURING, INC.
Surgical Gown, SMS2010-10-28
EXACT MEDICAL MANUFACTURING, INC.
SMS Surgical Gown2010-10-28
EXACT MEDICAL MANUFACTURING, INC.
ONYX-N1856, ONYX-N1857, ONYX-N1858, ONYX-N1859, ONYX-N1860, ONYX-N1861, ONYX-N1862, ONYX-N18632010-10-28
EXACT MEDICAL MANUFACTURING, INC.
ONYX-N1846, ONYX-N1847, ONYX-N1848, ONYX-N1849, ONYX-N1850, ONYX-N1851, ONYX-N1852, ONYX-N1853, ONYX-N1854, ONYX-N18552010-10-28
EXACT MEDICAL MANUFACTURING, INC.
ONYX-L-RE1, ONYX-XL-RE1, ONYX-N1838, ONYX-N1839, ONYX-N1840, ONYX-N1841, ONYX-N1842, ONYX-N1843, ONYX-N1844, ONYX-N18452010-10-28
EXACT MEDICAL MANUFACTURING, INC
EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS)2010-10-04
EXACT MEDICAL MANUFACTURING, INC
EMM EQUIPMENT COVER-POLYTHYLENE2010-09-20
EXACT MEDICAL MANUFACTURING, INC
EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-0042010-09-20
EXACT MEDICAL MANUFACTURING, INC
EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL2010-09-03

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092840991Shanghai ,China (Mainland) -> Oakland, CaliforniaFACE DRAPE400 CTN
2020092830604Puerto Manzanillo,Panama -> San Juan, Puerto RicoSURGICAL DRAPE SURGICAL GOWN567 CTN
2020092621558Shanghai ,China (Mainland) -> Houston, TexasSURGICAL DRAPE SURGICAL GOWN COVER BACK TABLE COVER BAG SENSOR HOLDER ICE PACK TOWEL KIT C LEANING BRUSH711 CTN
2020092633129Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New JerseySURGICAL GOWN552 CTN
202009258185Shanghai ,China (Mainland) -> Houston, TexasSURGICAL DRAPE SURGICAL GOWN63 CTN

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