FDA.reportPublic FDA data

FREUDENBERG MEDICAL, LLC

Matched from indexed company URL: Freudenberg Medical, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12221401000121130FREUDENBERG MEDICAL, LLC1N2026-01-012301 Centennial Blvd Jeffersonville IN US 47130
20251822025182Freudenberg Medical, LLC1N2026-01-011110 Mark Ave CARPINTERIA CA US 93013
20318973008581151Freudenberg Medical, LLC1N2026-01-015050 Rivergrade Rd Baldwin Park CA US 91706
30083286903008328690Freudenberg Medical Ireland Limited1N2026-01-01IDA Business & Technology Park, Carrick On Shannon, CO, Leitrim Leitrim IE N41 N8C9
30112412663011241266Freudenberg Medical, SRL1N2026-01-01Zona Franca Coyol Calle 4, Av. 0, Edificio B17 La Garita Alajuela CR 20113
30134450863013445086FREUDENBERG MEDICAL EUROPE GMBH1N2026-01-01Liebigstrasse 2-8 Kaiserslautern Rhineland-Palatinate DE 67661
30133122273013312227Freudenberg Medical, LLC1N2020-04-2592 Blackburn Center Gloucester MA US 01930

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00848253003399InHealth Technologies; Blom-Singer - Post-Operative Care Kit with 9/55 Tube & ClassicFlow HME800-477-5969inhealth@inhealth.com
00848253003405InHealth Technologies; Blom-Singer - Post-Operative Care Kit with 10/55 Tube & ClassicFlow HME800-477-5969inhealth@inhealth.com
00848253003412InHealth Technologies; Blom-Singer - Post-Operative Care Kit with 9/55 Tube & EasyFlow HME800-477-5969inhealth@inhealth.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
345401688740805K991587BLOM-SINGER INDWELLING 2000 VOICE PROSTHESISEWL1999-06-25
345401585902966K945288INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICEEWL1994-12-02
345401919101215K932163BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPETEWL1993-12-15
345401953237105K932120BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHESEWL1994-04-15
345401418948308K930105BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S.EWL1993-05-17
345401037983420K920090BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SETEWL1992-09-10
345401191450617K904729BLOM-SINGER SHOWER GUARDEWL1991-02-28
345401199466079K851082V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TESENW1985-07-22
345401193971351K800563BLOM-SINGER DUCKBILL VOICE PROSTHESISEWL1980-03-25
345401577947386K240763FirstFit Surgical KitEWL2024-12-18
118051190462867K192422Steerable Introducer 12FDRA2019-10-04
118052060947779K191190Steerable IntroducerDYB2019-08-01
118051140329279K190628FlexSeal Introducer Sheath with Hydrophilic CoatingDYB2019-05-30
1151671656306511K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar CageMAX2019-07-25
1151671796366497K181752Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)HRX2018-12-21
1749881697929072K172494PROTEUS PTA Balloon Catheter with Embolic Capture FeatureLIT2017-12-15
1151671631268028K172116Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)HRX2018-01-25
345401031060073K161273StageOne Disposable Cement Spacer Molds for Temporary Knee ProsthesisMBB2017-01-25
345401340539688K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisMBB2016-06-16
118051167327024K152069Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage CatheterFGE2015-09-24
118051543950616K150187ELITECROSS Support CatheterPDU2015-05-19
1749881493669976K133043PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURELIT2013-12-06
345401745158366K131745BLOM-SINGER SEPTAL PERFORATION PROSTHESISLFB2013-09-17
345401089897009K131135BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESISMBB2014-01-22
345401643086302K130736BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESISLRC2013-12-17
1151671631654731K130430IVAS 10MM AND 15MM BALLOON CATHETERHRX2013-05-23
1151672012434995K123942STRYKER IVAS BALLOON CATHETERNDN2013-04-03
118051680533903K111315MULTIPURPOSE DRAINAGE CATHETERFGE2011-06-08
1151671162422785K111031PAINFUSOR CATHETERBSO2011-07-08
118051238244522K103353MULTIPURPOSE DRAINAGE CATHETER; NEPHROSTOMY DRAINAGE CATHETER; BILIARY DRAINAGE CATHETERFGE2011-01-14
1151671318066940K093419IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVASNDN2010-03-18
118051618848697K093392MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERSFGE2009-12-31
345401518080760K093258BLOM-SINGER INDWELLING TEP OCCLUDEREWL2010-03-03
345401606196128K082206BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIESEWL2008-09-04
2136351803116167K071823PERMA FACIAL IMPLANTSODU2007-09-19
345401464918370K052990STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEMKWY2005-12-16
345401975335446K050210DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESESJWH2005-07-19
1151671379370262K031617MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETERKLA2004-01-16
1151671063138587K013704MEDIPLUS SINGLE USE GI MANOMETRY CATHETERKLA2002-08-05
1151671417300071K013536EMTRAC; DELPHIN; SEMTRAC 2000 SETMQF2001-11-30
1675991502415223
1151671585907538
1675991687134859
2136352026276859
345401002991728
118051049276038
118051067586958
345401080776269
118051141276869
1675991144320895
345401144320895
1675991152814933
345401201935619
345401202494153
1151671240538556
345401242404413
345401306843043
345401313325669
118051320051102
345401324887036
1675991324887036
118051333297968
118051415917632
118051455791819
3416431461817440
118051491421146
345401496608376
1749881538429674
118051575428177
1749881579354923
1151671606870038
1749881628207021
118051657775091
345401675734226
1675991675734226
1749881678089482
118051695288121
1151671798521708
1151671806150214
118051831555409
118051838739857
345401885196425
345401959600291
345401959962414
345401997681640
345402002669854
118052045968584
1749882072227330

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EWL112024-12-18
FGE42015-09-24
HRX32018-12-21
MBB32017-01-25
DYB22019-08-01
LIT22017-12-15
NDN22013-04-03
KLA22004-01-16
DRA12019-10-04
MAX12019-07-25
PDU12015-05-19
LRC12013-12-17
LFB12013-09-17
BSO12011-07-08
ODU12007-09-19
KWY12005-12-16
JWH12005-07-19
MQF12001-11-30
ENW11985-07-22

PMN#

GUDID#

EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING - The EMPOWER™ Introducer Sheath with Hydrophilic Coating consists of a single-use disposable introducer sheath and dilator that is inserted into the peripheral vasculature to support the introduction of diagnostic or interventional devices, while minimizing blood loss associated with such insertions. The EMPOWER™ Introducer Sheath is coil-reinforced and coated with a lubricious hydrophilic coating. The EMPOWER™ hemostasis valve is integrated into the sheath hub and features a variable aperture seal for enhanced control over device insertion while maintaining hemostasis. The valve is normally closed until the user squeezes the actuator levers to proportionally open the valve and receive any device up to its labeled size. A sideport extends from the EMPOWER™ valve housing with a 3-way stopcock. The radiopaque dilator is designed to accommodate an .035” (0.89mm) guidewire and includes a proximal hub grip with a female luer taper fitting for flushing. Prior to insertion, the dilator hub can be secured to the EMPOWER™ housing with a quarter-turn twist.

FREUDENBERG MEDICAL, LLC

2026-01-29

Blom-Singer® Nasal Septal Perforation Sizing Tool - The Nasal Septal Perforation Sizing Tool (NSPST) is a graded handheld device designed to measure nasal septal perforations. The device is available in oval and round configurations with gradations that coincide with the offered sizes of Blom-Singer® Nasal Septal Perforation Prostheses. The device provides a method for measurement of size and thickness of nasal perforations to aid in selection of the appropriate Blom-Singer® Nasal Septal Perforation Prosthesis. The NSPST is a single use, non-sterile, disposable, invasive, transient duration (<60mins) measuring accessory to the Blom-Singer Nasal Septal Perforation Prosthesis. Each will be packed in a sealed pouch, 5 sealed pouches in one carton box which is sold as 1 unit of SPT 002.

Freudenberg Medical, LLC

2025-03-14

EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING - The EMPOWER™ Introducer Sheath with Hydrophilic Coating consists of a single-use disposable introducer sheath and dilator that is inserted into the peripheral vasculature to support the introduction of diagnostic or interventional devices, while minimizing blood loss associated with such insertions. The EMPOWER™ Introducer Sheath is coil-reinforced and coated with a lubricious hydrophilic coating. The EMPOWER™ hemostasis valve is integrated into the sheath hub and features a variable aperture seal for enhanced control over device insertion while maintaining hemostasis. The valve is normally closed until the user squeezes the actuator levers to proportionally open the valve and receive any device up to its labeled size. A sideport extends from the EMPOWER™ valve housing with a 3-way stopcock.The radiopaque dilator is designed to accommodate an .035” (0.89mm) guidewire and includes a proximal hub grip with a female luer taper fitting for flushing. Prior to insertion, the dilator hub can be secured to the EMPOWER™ housing with a quarter-turn twist.

FREUDENBERG MEDICAL, LLC

2021-06-15

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