FDA.reportPublic FDA data

Genesis

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
16521113003427273GENESIS BIOSYSTEMS INC.1N2026-01-011500 Eagle Ct. Lewisville TX US 75057
21837412183741GENESIS INDUSTRIES, INC.1N2026-01-01601 PRO-JECT DR. ELMWOOD WI US 54740
22485881000527169GENESISBPS LLC1Y2026-01-01400 Corporate Dr Mahwah NJ US 07430
24375473001236376GENESIS INT'L, CORP.1Y2026-01-0152-01 flushing avenue room 12 Maspeth NY US 11378
30049614193004961419GENESIS DENTAL TECHNOLOGIES, LLC1N2026-01-01200 MAIN STREET ELMWOOD WI US 54740
30055432413005543241GENESIS MEDICAL PLASTICS LTD. CO.1N2026-01-0114863 GRANT RD Cypress TX US 77429
30097319333009731933Genesis Vision, Inc1Y2026-01-012512 Chambers Road Unit 105 Tustin CA US 92780
30100525293010052529GENESIS DESIGN & FABRICATION1N2026-01-011325 W Harwell Rd Gilbert AZ US 85233
30169485393008066433GENESIS BIOLOGICS, INC.1Y2026-01-0117791 Mitchell North Suite D Irvine CA US 92614
30195418963019541896GENESIS SOFTWARE INNOVATIONS1N2026-01-012851 Charlevoix Dr. SE Suite 327 Grand Rapids MI US 49546
30236184573023618457GENESIS SPORTS TECHNOLOGY COMPANY LIMITED1N2026-01-01Quoc Hung Hamlet Hai Hung Commune Ninh Binh VN 07912
30275344613027534461GENESIS AIR, INC.1N2026-01-015202 CR 7350 Suite D Lubbock TX US 79424
12254193000720036GENESIS MEDICAL PRODUCTS, INC.1Y2020-04-2540 FARMHILL RD. WRENTHAM MA US 02093
30077353453007735345GENESIS SPORTING GOODS COMPANY LTD.1N2020-04-25NO 145, GAOBU AVE NORTH,BAOANWEI VILLAGE GAOBU TOWN DONGGUAN Guangdong CN 523270
30080660343008066034GENESIS HEALTH TECHNOLOGY LLC1Y2020-04-25715 Kentucky Avenue Paducah KY US 42003
30166483803016648380GENESIS IMPORT INC.1Y2020-04-2512A Sycamore Avenue Bethpage NY US 11714

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850005827368AlternatiV+ Screw-In Anchor - 4.75MM SCREW-IN SUTURE ANCHOR657-888-6243ORDERS@GENESISBIOLOGICS.COM
00850005827375AlternatiV+ Screw-In Anchor - 5.5MM SCREW-IN SUTURE ANCHOR657-888-6243ORDERS@GENESISBIOLOGICS.COM
00850005827382AlternatiV+ Max Knotless Anchor - 4.75MM MAX KNOTLESS ANCHOR657-888-6243ORDERS@GENESISBIOLOGICS.COM

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
235831542180823K934436SBP DENTAL UNITEIA1994-06-02
2698621886934664K230892Fixone Biocomposite AnchorMAI2023-06-09
3186361503379223K222702RGS; RGS MiniFRA2023-06-02
2698622048081286K222423Fixone All Suture AnchorMBI2023-03-23
2937711770120393K210556Preview ShoulderQIH2021-04-21
2698621737794829K203523Fixone hybrid knotless anchorMAI2021-12-25
2005661866173988K181680ICONN Answer II Suture AnchorMBI2018-08-09
992791485784053K172714LipiVageMUU2017-12-08
2005661344377302K160498Dentivera Milling DiscEBI2016-06-15
992791182067674K131142GENESIS LED WANDSGEX2013-11-27
1670511998109149K121224GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEMLFR2012-09-19
509231326086083K082027FLU-ADMIN, MODELS 60150, 60150C, 60151C, 60153C, 60160FPA2009-02-13
509231599002809K05080530 ML OR 60 ML PEDI-SYRINGE FILTERBRZ2005-06-20
509231812763313BK950018
509231047534095BK850003
2698621933532160BK230807
992791397387182BK220714
509231095092013BK210584
2698621307536542BK170136
509231295215326BK140187
992791117580223
992791168403300
1002151208489020
992791508255961
1002151605710138
1528901720659464
509231940219659
61641129798973
3081751310705300
2698621639452172
61641682216510
2005661690212222
992791797127360
2005661866173988
235832047840351

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAI22023-06-09
MBI22023-03-23
FRA12023-06-02
QIH12021-04-21
MUU12017-12-08
EBI12016-06-15
GEX12013-11-27
LFR12012-09-19
FPA12009-02-13
BRZ12005-06-20
EIA11994-06-02

NDC#

OXYGEN

Genesis Respiratory Services

OXYGEN

PMN#

LipiVage

2017-12-08

Genesis Biosystems, Inc.

EVERT-IT

1997-02-10

Genesis Industries, Inc.

C & B 45

1983-12-29

GENESIS INDUSTRIES, INC.

49 records. Showing 1-40. Next

GUDID#

Genesis Tube Stripper - The Tube Stripper is a “plier-like” tool used to strip/expel undiluted residual blood, in the PVC tubing segment, back into the blood component bag. The Tube Stripper operates on the principle of using two rolling wheels to squeeze fluid forward. The operator manually places the PVC tubing segment between the two roller wheels, grips the clamp body, and slides the Tube Stripper forward along the PVC tubing segment. As the segment is compressed between the two roller wheels, the residual blood within the PVC tubing segment flows forward until it completely drains into the blood component bag. When used in blood/blood component processing applications, the Tube Stripper facilitates manual mixing with anticoagulant and red cells. The Tube Stripper has no intended medical purpose and is not intended for in vitro use in blood banking.

GENESIS BPS LLC

2025-01-31

ProVoyance PreOp Shoulder - The PreOp Shoulder software is intended to be used as a tool for orthopedic surgeons to develop pre-operative shoulder plans based on a patient CT imaging study. The import process allows the user to select a DICOM CT scan series from any location that the user's computer sees as an available file source. 3D digital representations of various implant models are available in the planning software. Pre-Op Shoulder allows the user to digitally perform the surgical planning by showing a representation of thepatient's shoulder anatomy as a 3D model and allows the surgeon to place the implant in the patient's anatomy. The software allows the surgeon to generate a report, detailing the output of the planning activity. Experience in usage and a clinical assessment are necessary for a proper use of the software. It is to be used for adult patients only and should not be used for diagnostic purposes.Instructions for use can be found at the following location: https://portal.si.genesisplanningsoftware.com/

Genesis Software Innovations LLC

2024-05-31

50 records. Showing 1-40. Next