Manufacturer Intelligence · Based on 18,495 FDA 510(k) records · 70 countries

FDA 510(k) Medical Device Manufacturers - United Kingdom

UK medical device manufacturers ranked by FDA 510(k) submission volume. This is not a curated directory - rankings reflect real submission activity extracted from FDA accessdata.gov records.

  • Compare manufacturers by FDA 510(k) submission activity
  • Identify clearance rates, active panels and years of FDA activity
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150
Manufacturers
United Kingdom
Country

United Kingdom Manufacturers

1–50 of 150
# Manufacturer Submissions Cleared Active panels Country
1 11 100%
RA
GB
2
Cyden Limited
Swansea, Wales
7 100%
SU
GB
3 7 100%
SU
GB
4 7 100%
GU SU
GB
5 6 83%
CV NE
GB
6
Spectrum Medical , Ltd.
Gloucester, Gloucesterhsire
6 100%
CV
GB
7 6 100%
RA
GB
8 5 100%
OP
GB
9
Tenscare, Ltd.
Timperley, Cheshire
5 100%
GU NE
GB
10 5 100%
OR SU
GB
11 5 100%
MI
GB
12
3M Healthcare Business Group
Berkshire, Bracknell Forest
5 100%
SU
GB
13 5 100%
RA
GB
14 4 100%
OR
GB
15 4 100%
RA
GB
16
Vascutek, Ltd.
Pa49rr Scotland
4 100%
CV
GB
17 4 100%
NE
GB
18 4 100%
CH IM TX
GB
19 4 100%
CV RA
GB
20 3 100%
CH
GB
21 3 100%
CH TX
GB
22 3 100%
CV OB
GB
23 3 100%
SU
GB
24 3 100%
GU
GB
25 3 100%
GU
GB
26 3 100%
OR
GB
27 3 100%
AN
GB
28 3 100%
RA
GB
29 3 100%
CH
GB
30 3 100%
SU
GB
31 3 100%
SU
GB
32 3 100%
NE PM
GB
33 2 100%
CH
GB
34 2 100%
CH TX
GB
35 2 100%
SU
GB
36 2 100%
SU
GB
37 2 100%
HO
GB
38 2 100%
SU
GB
39 2 100%
AN
GB
40
Xstrahl, Ltd.
Brownhills
2 100%
RA
GB
41 2 100%
CV
GB
42
Zethon, Ltd.
Aston Clinton
2 100%
EN NE
GB
43 2 100%
SU
GB
44 2 100%
OB
GB
45 2 100%
OB
GB
46 2 100%
GU
GB
47 2 100%
SU
GB
48 2 100%
SU
GB
49 2 100%
OR
GB
50 2 50%
AN
GB

About This FDA 510(k) Manufacturer Database

Data Source and Methodology

Rankings are based on the total number of published FDA 510(k) submissions per manufacturer in the 510k Database dataset, derived from FDA 510(k) public files. This is not a curated or paid listing - manufacturer rankings reflect real regulatory activity.

Used by regulatory affairs teams and medtech consultants to benchmark manufacturer activity, identify predicate device candidates, and analyze competitive positioning across FDA review panels.