Manufacturer Intelligence · Based on 21,295 FDA 510(k) records · 72 countries

FDA 510(k) Medical Device Manufacturers - India

Indian 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
  • Filter by country or FDA review panel specialty
78
Manufacturers
India
Country

India FDA 510(k) Overview

78
Manufacturers
149
Submissions
100%
Clearance rate

Leading India FDA 510(k) manufacturers include Auxein Medical Private Limited, Qure.Ai Technologies, M/s. Meril Endo Surgery Private Limited. and 75 others.

Indian medical device manufacturers have submitted 149 FDA 510(k) notifications since 2020, with a 100% clearance rate across 78 manufacturers. India's growing presence in the FDA 510(k) dataset reflects the country's expanding manufacturing capacity, particularly in disposable devices, diagnostic equipment and in vitro diagnostics.

Active in FDA 510(k) submissions since 2020. Many India manufacturers work with FDA regulatory consultants to support U.S. market entry.

FDA 510(k) India Manufacturers

1–50 of 78
# Manufacturer Submissions Cleared Active panels Country
1
Auxein Medical Private Limited
Sonipat
12 100%
OR
IN
2
Qure.Ai Technologies
Mumbai
9 100%
RA
IN
3
M/s. Meril Endo Surgery Private Limited.
Chala, Vapi
7 100%
OR SU
IN
4
Prevest Denpro Limited
Bari Brahmana
7 100%
DE
IN
5
Poly Medicure Limited
Jaipur
6 100%
HO
IN
6
Allengers Medical Systems Limited
Derabassi, Distt Mohali
5 100%
RA
IN
7
Healthium Medtech Limited
Bangalore
5 100%
OR
IN
8
S.H.Pitkar Orthotools Pvt. , Ltd.
Pune
4 100%
OR
IN
9
Amazing Rubber Products Pvt, Ltd.
Cochin
4 100%
HO
IN
10
Skanray Technologies Limited
Mysore
4 100%
RA
IN
11
Meril Healthcare Pvt. , Ltd.
Muktanand Marg, Chala, Vapi
3 100%
OR
IN
12
Johari Digital Healthcare Limited
Jodhpur
3 100%
PM
IN
13
Ttk Healthcare Limited
Puducherry
3 100%
OB
IN
14
Gpc Medical Limited
New Delhi
2 100%
OR
IN
15
Prognosys Medical Systems Private Limited
Bangalore
2 100%
RA
IN
16
Global Medikit Limited
Dehradun
2 100%
AN HO
IN
17
Indius Medical Technologies Pvt. , Ltd.
Pune
2 100%
OR
IN
18
Safey Medical Devices Pvt, Ltd.
Pune
2 100%
AN
IN
19
Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.
Mahape, Navi Mumbai
2 100%
HO OP
IN
20
Solco Biomedical Company India Private Limited
Village-Rajpur
2 100%
OR
IN
21
Lifelong Meditech Private Limited
Gurgaon
2 100%
HO
IN
22
Panacea Medical Technologies Pvt. , Ltd.
Malur, Kolar District
2 100%
RA
IN
23
Allengers Global Healthcare Private Limited
Derabassi, District- Mohali
2 100%
SU
IN
24
Spm Medicare Pvt. , Ltd.
Gautam Budh Nagar
2 100%
HO
IN
25
Veol Medical Technologies Pvt , Ltd.
Navi Mumbai
2 100%
OB SU
IN
26
Greens Surgicals Pvt. , Ltd.
Vadodara
1 100%
OR
IN
27
Philips India Limited
Pune
1 100%
RA
IN
28
Forus Health Pvt.Ltd
Bengaluru
1 100%
OP
IN
29
Biorad Medisys Pvt, Ltd.
Pune
1 100%
OR
IN
30
Cupid Limited
Nashik
1 100%
OB
IN
31
Auxein Medical Private Limited/71164
Sonipat
1 100%
OR
IN
32
Mediplus (India) Limited
Bahadurgarh
1 100%
HO
IN
33
Esstee Exports Health Care Division
Tirupur
1 100%
HO
IN
34
Mrk Healthcare Pvt, Ltd.
Patan
1 100%
HO
IN
35
Laxmi Dental Exports Pvt, Ltd.
Boisar
1 100%
DE
IN
36
Maf Clothing Pvt Ltd Unit-3
Karnataka
1 100%
HO
IN
37
Welspun India Limited
District:Kutch
1 100%
HO
IN
38
Allure Gift Wraps Private Limited
Vapi
1 100%
HO
IN
39
Niramai Health Analytix Private Limited
Bangalore
1 100%
RA
IN
40
Control Print Limited
District Solan
1 100%
HO
IN
41
Rivarp Medical Private Limited
Bangalore
1 100%
OR
IN
42
Magnum Health and Safety Pvt, Ltd.
Taluka - Vasai, Dist - Palghar
1 100%
HO
IN
43
Koove Iot Pvt. , Ltd.
Paschim Midnapur
1 100%
HO
IN
44
Sigtuple Technologies Pvt. , Ltd.
Bangalore
1 100%
HE
IN
45
Turtle Shell Technologies Private Limited
Bengaluru
1 100%
AN
IN
46
Hospital Equipment Manufacturing Company
Noida
1 100%
OR
IN
47
Roundworks Technologies Private Limited
Wakad, Pune
1 100%
AN
IN
48
Nesa Medtech Private Limited
Bengaluru
1 100%
RA
IN
49
Deeptek Medical Imaging Private Limited
Pune
1 100%
RA
IN
50
Dentcare Dental Lab Pvt , Ltd.
Ernakulam
1 100%
DE
IN

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.