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

Rangendingen Baden-Wurttemberg, DE

ERBE ELEKTROMEDIZIN GMBH appears in FDA device records in Rangendingen Baden-Wurttemberg, DE. FDA records list 16 510(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
16
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 16 510(k) clearances for ERBE Elektromedizin GmbH between 1994 and 2026. The busiest year on record is 2025, with 4. The most recent is 2026, with 2.

Clearances by year, as a table
510(k) clearance decisions for ERBE Elektromedizin GmbH, by decision year
YearClearances
19941
20161
20193
20201
20232
20242
20254
20262
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K261806ERBECRYO 2 Cryosurgical Unit and AccessoriesGEHSubstantially Equivalent
K253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeGEHSubstantially Equivalent
K253915MOVIVA® Hybrid Ablation ProbeGEISubstantially Equivalent
K251108Erbe ESU Model VIO® 3n with AccessoriesGEISubstantially Equivalent
K243120HybridAPC probeGEISubstantially Equivalent
K243451FiAPC plus probesGEISubstantially Equivalent
K242044FiAPC plus probesGEISubstantially Equivalent
K240932HybridTherm SystemGEISubstantially Equivalent
K232033HYBRIDknife® flexGEISubstantially Equivalent
K231023ERBEJET® 2 SystemFQHSubstantially Equivalent
K190651ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapterGEHSubstantially Equivalent
K191234APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening setsGEISubstantially Equivalent
K190823Erbe ESU Model VIO 3 with AccessoriesGEISubstantially Equivalent
K183445Erbe APCapplicatorsGEISubstantially Equivalent
K150364ERBE ESU Model VIO dV with AccessoriesGEISubstantially Equivalent
K934261ERBOKRYO CA CRYOSURGICAL SYSTEMGEHSubstantially Equivalent

Registered establishments

FDA registered establishments for ERBE Elektromedizin GmbH, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96106143002806920ERBE ELEKTROMEDIZIN GMBHWALDHOERNLESTRASSE 17, TUEBINGEN Baden-Wurttemberg 72072 DE2026
30097624503009762450ERBE Elektromedizin GmbHRudolf-Diesel-Str. 29, Rangendingen Baden-Wurttemberg 72414 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

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