ClearanceBrief
Company ยท US

Freudenberg Medical, LLC

FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2024. Name variants (Inc, Corp, punctuation) are merged.

3510(k) clearances (0 in 12 months)
4recalls (2 in 12 months)
4recalls that name a 510(k)

Product codes

CodeDeviceRecords
DYBIntroducer, Catheter3
EWLProsthesis, Laryngeal (Taub)3
DRACatheter, Steerable1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Dec 18, 2024K240763FirstFit Surgical Kit
Freudenberg Medical, LLC
EWL
Oct 4, 2019K192422Steerable Introducer 12F
Freudenberg Medical, LLC
DRA
Aug 1, 2019K191190Steerable Introducer
Freudenberg Medical, LLC
DYB

Latest recalls

DateFirm and productCodeLinked 510(k)
Aug 6, 2026Freudenberg Medical, LLC
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
Open, Classified		 EWLK932120
Aug 6, 2026Freudenberg Medical, LLC
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
Open, Classified		 EWLK932120
Feb 21, 2022Freudenberg Medical, Llc
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)
Terminated		 DYBK190628
Feb 21, 2022Freudenberg Medical, Llc
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
Terminated		 DYBK190628
Get alerts for these product codes