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

GOLDACH Sankt Gallen, CH

NOUVAG AG appears in FDA device records in GOLDACH Sankt Gallen, CH. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
11
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 11 510(k) clearances for Nouvag AG between 1996 and 2009. The busiest year on record is 2004, with 3. The most recent is 2009, with 1.

Clearances by year, as a table
510(k) clearance decisions for Nouvag AG, by decision year
YearClearances
19961
19991
20001
20011
20031
20043
20071
20081
20091
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K080365MORCE POWER PLUS AND VARIOCARVE MORCELLATORHETSubstantially Equivalent
K081191TCM ENDO 20EKXSubstantially Equivalent
K071588DISPENSER DP 20FRNSubstantially Equivalent
K042822TCM ENDO V, MODEL 1534EKXSubstantially Equivalent
K042943NOUVAG AG - VACUSON 40 AND VACUSON 60BTASubstantially Equivalent
K042434MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55DZISubstantially Equivalent
K022505CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068,EGSSubstantially Equivalent
K013185TCM ENDO IIIEFASubstantially Equivalent
K000710MD 10, SEM, SM 12, CBMEFBSubstantially Equivalent
K981679TCM 3000 AND TCM ENDOEFBSubstantially Equivalent
K954722MICRO-DISPENSER 7000 & MICRODISPENSER 8000EFBSubstantially Equivalent

Registered establishments

FDA registered establishments for Nouvag AG, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96807413005601686NOUVAG AGST. GALLERSTRASSE 25, GOLDACH Sankt Gallen 9403 CH2026and 7 more, listed in full below

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

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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