Erbe USA, Inc.
Erbe USA, Inc. holds FDA 510(k) medical device clearances, first cleared 1994, most recent 2022, with 4 FDA device recalls on record.
Top product codes for Erbe USA, Inc.
FDA recalls by Erbe USA, Inc.
- Z-2938-2026 — ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
- Z-1566-2026 — Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILEEO. For surgical use
- Z-1568-2026 — Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use
- Z-1567-2026 — Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Erbe USA, Inc.
- K221177 — Erbe's Tubing/Cap Sets
- K191438 — ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector
- K190469 — ERBEFLO 2 Disposable Tubing System
- K182444 — ERBEFLO Olympus Scope Port Connector
- K162152 — Erbes CO2 Tubing/Cap Sets
- K143306 — ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe
- K151041 — ERBECRYO 2 Cryosurgical Unit with accessories
- K143186 — Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector
- K132340 — ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1
- K133180 — ERBE ESU MODEL VIO DV WITH ACCESSORIES
- K103696 — ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES
- K103235 — ERBEFLO 2 DISPOSABLE TUBING SYSTEM
- K101108 — ERBE ESU MODEL VIO 100 C WITH ACCESSORIES
- K083608 — ERBE HYBRID KNIFE
- K083452 — ERBE MODEL VIO 300 D WITH ACCESSORIES
- K080715 — ERBE VIO ESU, MODEL VIO 200 S
- K072404 — ERBE ERBEJET 2 SYSTEM
- K062712 — ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20139-094
- K060484 — ERBE VIO ESU, MODEL VIO 300 D
- K060170 — ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS
- K060183 — ERBE APC INTEGRATED FILTER PROBES; ERBE APC INTEGRATED FILTER PROBE ADAPTER
- K051509 — ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES
- K033421 — ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS
- K033590 — ERBE HELIX HYDRO-JET
- K024047 — ERBE VIO APC WITH ACCESSORIES
- K023886 — ERBE VIO ESU WITH ACCESSORIES, MODEL VIO 300 D
- K023812 — NESSY (OMEGA) DISPOSABLE SPLIT RETURN ELECTRODES, MODELS P/N: 20193-084 AND P/N: 20193-085
- K022613 — HELIX HYDRO-JET
- K013348 — MODIFICATION TO: ERBE APC CONNECTOR HOSE AND PROBES, MODELS 20132-158, 20132-155, 20132-156, 20132-157, 20132-166
- K003462 — ERBE APC HANDLE AND APPLICATORS, MODEL 20132-043,20132-031,20132-032,20132-033,20132-034,20132-040,20132-044,20132-045
- K992764 — ERBE APC RASPATORY HANDLE AND TIP, MODEL 20132-102, 20132-103
- K992769 — ERBE APC APPLICATORS, MODELS 20132-106, 20132-107, 20132-109, 20132-110, 20132-11, 20132-112,20132-113, 20132-114, 2013-
- K972269 — DISPOSABLE PATIENT RETURN ELECTRODE
- K963189 — ERBE APC 300 ARGON PLASMA COAGULATOR AND ACCESSORIES - ARGON PLASMA COAGULATOR AND ACCESSORIES
- K960569 — DISPOSABLE PATIENT RETURN ELECTRODE
- K953159 — ERBOTOM ICC BIPOLAR
- K935815 — ERBOTOM ICC 50
- K933002 — ERBOTOM ICC 350
- K933157 — ERBOTOM ICC 200
Data sourced from openFDA. This site is unofficial and independent of the FDA.