Manufacturer Intelligence · Based on 18,519 FDA 510(k) records · 70 countries

FDA 510(k) Medical Device Manufacturers - Israel

Israeli 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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215
Manufacturers
Israel
Country

Israel Manufacturers

1–50 of 215
# Manufacturer Submissions Cleared Active panels Country
1 30 100%
RA
IL
2 19 100%
OR
IL
3 16 100%
OR
IL
4 14 100%
GU PM SU
IL
5 11 100%
NE SU
IL
6 11 100%
NE PM SU
IL
7 8 88%
SU
IL
8 8 100%
RA
IL
9 7 86%
CV NE
IL
10 7 100%
NE
IL
11 6 83%
AN CV EN
IL
12 5 100%
RA
IL
13 5 100%
CV
IL
14
Augmedics, Ltd.
Yokneam Illit
5 100%
OR
IL
15 5 100%
HO
IL
16 5 100%
SU
IL
17 5 100%
HO
IL
18 5 100%
SU
IL
19 4 100%
OR
IL
20 4 100%
DE
IL
21 4 100%
DE
IL
22 4 100%
RA
IL
23
Spectrum Dynamics Medical, Ltd.
North Industrial Park. Caesarea
4 100%
RA
IL
24 4 100%
GU
IL
25 3 100%
RA
IL
26 3 100%
SU
IL
27 3 100%
GU
IL
28 3 100%
RA
IL
29 3 100%
NE
IL
30
Tuttnauer , Ltd.
Beit Shemesh
3 100%
HO
IL
31 3 100%
CV
IL
32 3 67%
HE
IL
33 3 100%
OP SU
IL
34 3 67%
GU
IL
35 3 100%
MI
IL
36 3 67%
GU
IL
37 3 100%
MI
IL
38 3 100%
DE
IL
39 3 100%
DE HO
IL
40 3 100%
OR
IL
41 2 100%
RA
IL
42 2 100%
SU
IL
43 2 100%
GU
IL
44 2 100%
NE
IL
45 2 50%
DE
IL
46
P-Cure, Ltd.
Netanya, Hasharon
2 100%
RA
IL
47 2 100%
SU
IL
48 2 100%
OR
IL
49 2 100%
DE
IL
50
DreaMed Diabetes, Ltd.
Petah Tikva, Pob 3271
2 100%
CH
IL

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.