Gambro Healthcare FDA Record
Gambro Healthcare has 0 FDA recalls, 0 inspections, 13 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Gambro Healthcare" is on file.
- Latest recall
- Z-0151-2027 · Sep 14, 2026 · filed under Baxter Healthcare Corporation
- Latest 510(k)
- Oct 26, 2000
Newer recall under related name Baxter Healthcare Corporation: Sep 14, 2026, Z-0151-2027.
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 13 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Reviewing Gambro Healthcare as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check Gambro Healthcare yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K994390 | GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER | Oct 26, 2000 |
| K990039 | GAMBRO DQM 200 | Jan 27, 2000 |
| K982413 | COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS | Apr 21, 1999 |
| K982414 | GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS | Mar 26, 1999 |
| K980386 | HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, &… | Feb 24, 1999 |
| K982760 | COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET | Nov 4, 1998 |
| K982818 | HOSPAL TIPSTOP | Oct 21, 1998 |
| K974899 | GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H | Sep 23, 1998 |
| K981681 | PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) | Aug 11, 1998 |
| K981085 | GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM | May 18, 1998 |
| K970253 | COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET | Sep 26, 1997 |
| K962427 | COBE CENTRYSYSTEM 700 HG HEMODIALYZER | Sep 20, 1996 |
| K954623 | REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR) | Aug 28, 1996 |
Gambro Healthcare and the FDA: common questions
Has Gambro Healthcare received an FDA warning letter?
No FDA warning letter addressed to the name "Gambro Healthcare" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Gambro Healthcare received an FDA Form 483?
FDA has not published a Form 483 for "Gambro Healthcare" in its reading room. FDA publishes some Form 483s, not all of them.
Need more than this page shows? Ask about Gambro Healthcare in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.