Company ยท US
Wipro GE Healthcare Private Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2013. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
10recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 22, 2013 | K123681 | 1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL Wipro GE Healthcare Private, Ltd., IN | MOS |
| Sep 14, 2012 | K121625 | LULLABY TM WARMER Wipro GE Healthcare Private, Ltd. | FMT |
| May 2, 2012 | K120168 | LULLABY LED PHOTTHERAPY SYSTEM Wipro GE Healthcare Private, Ltd. | LBI |
| Jul 19, 2011 | K110556 | MINI TELEMETRY SYSTEM Wipro GE Healthcare Private, Ltd. | HGM |
| Oct 1, 2010 | K102104 | GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM Wipro GE Healthcare Private, Ltd. | IYN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2025 | Wipro GE Healthcare Private Ltd. GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical Display, cathode ray tube Open, Classified |
DXJ | K162012 |
| Oct 21, 2025 | Wipro GE Healthcare Private Ltd. GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, cathode ray tube Open, Classified |
DXJ | K162012 |
| Sep 20, 2024 | Wipro GE Healthcare Private Ltd. GE Panda iRES Warmer, Model/Catalog Numbers:
1) M1112198-01045518;
2) M1112198-01045579;
3) M1112198-01047148;
4) M1112198-01047271;
5) M1112198-01048731;
6) M1112198-01048740;
7) M1112198-010 Open, Classified |
FMT | K201628 |
| Sep 20, 2024 | Wipro GE Healthcare Private Ltd. GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiolo Open, Classified |
FMT | K201628 |
| Feb 9, 2024 | Wipro GE Healthcare Private Ltd. GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822 Open, Classified |
FMZ | None listed |
| Feb 9, 2024 | Wipro GE Healthcare Private Ltd. GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260, M1166836, M1166814 Open, Classified |
FMZ | None listed |
| Feb 9, 2024 | Wipro GE Healthcare Private Ltd. GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-0504-800, 6600-0148-800, and 6600-0970-500 Open, Classified |
FMZ | None listed |
| Feb 9, 2024 | Wipro GE Healthcare Private Ltd. GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: 6600-0047-851, 6600-0033-850, 6600-0081-850, 6600-0961-500, 6600-0083-850 Open, Classified |
FMZ | None listed |
| Feb 9, 2024 | Wipro GE Healthcare Private Ltd. GE Healthcare neonatal incubator, models:
a) Lullaby Incubator,
b) Lullaby Incubator XP,
c) Lullaby Incubator TR Open, Classified |
FMZ | None listed |
| Feb 9, 2024 | Wipro GE Healthcare Private Ltd. GE Healthcare neonatal incubator, models:
a) Care Plus,
b) Care Plus 1000,
c) Care Plus 2000,
d) Care Plus 3000,
e) Care Plus 4000, Plus 4000 Open, Classified |
FMZ | K871399 K901585 +4 |