Company ยท SE
Carmel Pharma Ab.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2011. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 12, 2011 | K110023 | INFUSION ADAPTER C100 Carmel Pharma Ab., SE | LHI |
| Dec 7, 2009 | K092782 | INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35, Carmel Pharma Ab., SE | LHI |
| Mar 23, 2009 | K090634 | PHASEAL PROTECTOR P14, P21, P28 AND P50 Carmel Pharma Ab., SE | LHI |
| Apr 28, 2006 | K060866 | PHASEAL - CLOSED SYSTEM FOR THE PREPARATION AND ADMINISTRATION OF PARENTERAL DRUGS Carmel Pharma Ab., SE | LHI |
| Nov 15, 2002 | K023747 | PHASEAL Carmel Pharma Ab., SE | LHI |
| May 12, 2000 | K001368 | PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER Carmel Pharma Ab., SE | LHI |
| Mar 3, 1998 | K980381 | PHASEAL, CLOSED SYSTEM FORHANDLING OF PARENTERAL DRUGS, ADDITIONAL ADMINISTRATION DEVICES. C80 INFUSION ADAPTER, A10 PRO Carmel Pharma Ab., SE | LHI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2007 | Carmel Pharma, Inc. PhaSeal, Protector 50, Item No. 50, US Order No. 10310 Terminated |
FPA | K001368 |
| Aug 22, 2007 | Carmel Pharma, Inc. PhaSeal, Protector 21, Item No. 21, US Order No. 22020 Terminated |
FPA | K001368 |
| Aug 22, 2007 | Carmel Pharma, Inc. PhaSeal Injector Luer Lock, Item No. 31, US Order No. 10310 Terminated |
FPA | K001368 |
| Aug 22, 2007 | Carmel Pharma, Inc. PhaSeal, Protector 14, Item No. P14, US Order No. 21320 Terminated |
FPA | K001368 |