510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Medicel AG

Altenrhein Sankt Gallen, CH

MEDICEL AG appears in FDA device records in Altenrhein Sankt Gallen, CH. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
6
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 6 510(k) clearances for Medicel AG between 2004 and 2025. The busiest year on record is 2004, with 1. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Medicel AG, by decision year
YearClearances
20041
20071
20091
20101
20231
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K252540ACCUJECT Injector Set 2.1-1P (LP604590)MSSSubstantially Equivalent
K231106Accuject Refra Injector AR2900MSSSubstantially Equivalent
K101134VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430MSSSubstantially Equivalent
K092023NAVIJECT SUB2-1P, MODEL: LP604430MSSSubstantially Equivalent
K070669IOL INJECTOR SETKYBSubstantially Equivalent
K040837MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGEMSSSubstantially Equivalent

Registered establishments

FDA registered establishments for Medicel AG, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96818621000581837MEDICEL AGDornierstrasse 11, Altenrhein Sankt Gallen CH-9423 CH2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1984-2013Product Name: nanoPOINT Injector System, item number 37-0000-08. Intended to fold and insert a STAAR Surgical Collamer nanoFLEX or Afinity IOLs, through surgical procedure in a human eye.The firm initiated this recall of one lot (121402) of nanoPOINT Injectors after they noticed that Tyvek lids might have been damaged and, therefore, the stability of the sterile barrier might be negatively affected.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain