HomeUSATHE ANSPACH EFFORT, INC.

THE ANSPACH EFFORT, INC.

USA · Palm Beach Gardens
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Israel — 9 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
19listed device types
Class I 11Class II 8Class III 0
plus 30 registration records and 60 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
5registered devices
Class I 1Class II 4
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
2registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
3active device licences
Class II 1Class III 2
12 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
3device registrations
CLASS B 3
KRSouth KoreaMFDS GMP
3GMP quality-system certificates
Import 3
AUAustraliaTGA ARTG
27active ARTG entries
Class I 7IIa 19Class Is (sterile) 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States30 registration records, 60 510(k), 0 PMA, 2 excluded
Brazil5 confirmed, 0 excluded
Saudi Arabia2 confirmed, 0 excluded
Canada3 confirmed, 0 excluded
Manufacturer names merged into this page: THE ANSPACH EFFORT, INC. · THE ANSPACH EFFORT INC. · THE ANSPACH EFFORT INC · The Anspach Effort, Inc.

Company information

Country
USA
City
Palm Beach Gardens

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

11993
11994
11995
31996
31997
31998
12000
12001
12002
12003
32004
22005
22007
22008
12011
12013
12014
12018
12019
12022

FDA listed device types

showing 8 of 19
Motor, Surgical Instrument, Ac-Powered 1Bur, Surgical, General & Plastic Surgery 1Bit, Drill 1Bur, Ear, Nose And Throat 1Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment 1Tray, Surgical 1Blade, Saw, General & Plastic Surgery, Surgical 1Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment 1

Registration details (sample)

MarketIdentifierNameClass / date
USK220485Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)2022-05-19
USK183545Anspach Helix Dissection Tools2019-07-19
USK180063OCM-G1 Attachment2018-03-27
BR80145901815Instrumental Não Articulado Cortante Estéril, com inserto de diamanteClass II
BR80145901811Instrumental Não Articulado Cortante EstérilClass II
BR80145901584MOTOR PNEUMÁTICO XMAXClass II
SAME0000003203SFDAA00054Attachment Cleaning Brushes (one 7 in Brush and One 12 in Brush)
SAME0000003203SFDAA00053Small Diameter Cleaning Brush
CA239ANSPACH ORTHOPAEDICS ANCHOR SYSTEMClass III
CA7263ANSPACH ACCESS CRANIAL PERFORATORClass II
CA72866ANSPACH ARTHROSCOPIC KNOTLESS CUFF ANCHOR SYSTEMClass III

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