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

VELEN North Rhine-Westphalia, DE

MEDI-GLOBE GMBH appears in FDA device records in VELEN North Rhine-Westphalia, DE. FDA records list 26 510(k) clearances between and , no PMA records and 2 registered establishments. 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
26
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 26 510(k) clearances for Medi-Globe GmbH between 1990 and 2026. The busiest year on record is 1995, with 5. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Medi-Globe GmbH, by decision year
YearClearances
19901
19944
19955
19962
19991
20021
20032
20051
20062
20071
20092
20142
20161
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K251658Endoflux™ Biliary & Pancreatic Stent SetsFGESubstantially Equivalent
K153264EasyPass GuidewireOCYSubstantially Equivalent
K142258PolyCatch Retrieval DeviceFDISubstantially Equivalent
K133763SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEMFCGSubstantially Equivalent
K091257MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEMFCGSubstantially Equivalent
K083802SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025FCGSubstantially Equivalent
K070129SONOTIP II ULTRASOUND NEEDLE SYSTEMFCGSubstantially Equivalent
K061222INJECTRA INJECTION NEEDLEFBKSubstantially Equivalent
K061684MEDI-GLOBE ROTA-CUT SPHINCTEROTOMEKNSSubstantially Equivalent
K051247SONOTIP II ULTRASOUND NEEDLE SYSTEMFCGSubstantially Equivalent
K011261STONE EXTRACTOR BALLOON CATHETERFGESubstantially Equivalent
K010714EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830FGESubstantially Equivalent
K010549BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS)FGEUnknown
K990220MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEMFCGSubstantially Equivalent
K953355GIP/MEID-GLOBE HOT BIOPSY FORCEPSKGESubstantially Equivalent
K955558GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLESFBKSubstantially Equivalent
K953827GIP/MEDI-GLOBE ERCP CATHETERSFGESubstantially Equivalent
K941973GIP/MEDI-GLOBE GUIDE WIRES & WIND-UP GUIDE WIRESFGESubstantially Equivalent
K943935GIP/MEDI-GLOBE POLYPECTOMY SNARESFDISubstantially Equivalent
K943629GIP/MEDI-GLOBE PAPILLOTOMEKNSSubstantially Equivalent
K935844GIP/MEDI-GLOBE NEEDLE SYSTEM FOR ULTRASONIC FNAFCGSubstantially Equivalent
K943476GIP/MEDI-GLOBE GOREIGN BODY GRASPERSOCZSubstantially Equivalent
K942544GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETSLQCSubstantially Equivalent
K942005GIP/MED-GLOBE STONE EXTRACTOR BASKETSLQRSubstantially Equivalent
K941359GIP/MEDI-GLOBE BIOPSY FORCEPSFCLSubstantially Equivalent
K900459APPLICARD (EKG)DRYSubstantially Equivalent

Registered establishments

FDA registered establishments for Medi-Globe GmbH, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30111469963011146996MEDI-GLOBE GMBHLOGISTICS CENTER, VELEN North Rhine-Westphalia 46342 DE2026
96808093002995060MEDI-GLOBE GMBHMedi-Globe Strasse 1-5, Achenmuhle, Germany Bavaria 83101 DE2026

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

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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