FDA.reportPublic FDA data

ACUMED INSTRUMENTS CORP.

Matched from indexed company URL: ACUMED LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20831242083124ACUMED INSTRUMENTS CORP.1N2026-01-011050 Vista de la Mesa Drive Santa Barbara CA US 93110
30251411000125930ACUMED LLC1Y2026-01-015885 NE Cornelius Pass Rd Hillsboro OR US 97124
30083964643008396464Acumed LLC -Brookwood Facility1N2026-01-014860 NE Brookwood Parkway Hillsboro OR US 97124
30094936613009493661Acumed Medical Ltd.1Y2026-01-013728 Philips Hwy Unit 18 Jacksonville FL US 32207

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
10806378040368ACUMED - 1.5mm A/O Solid Hex Driver Tip+1(888)627-9957businessservices@acumed.net
10806378099182ACUMED - FFN +0.4 mm End Cap - Sterile Packed+1(888)627-9957businessservices@acumed.net
10806378116094ACUMED - FFN Multiple Contact Hammer+1(888)627-9957businessservices@acumed.net
10806378116131ACUMED - FFN +5 mm End Cap - Sterile packaged+1(888)627-9957businessservices@acumed.net

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
432431758183636K992525ACUMED MODULAR SHOULDER SYSTEMHSD2000-02-04
432431185413768K980103ACUMED SUTURE ANCHORMBI1998-03-16
432431049141918K965029STABLELOC II EXTERNAL FIXATORJEC1997-02-19
432431013430159K964500ACUMED TENSION BAND PINHTY1996-12-09
432431068519894K963118EXTREMITY BONE SCREWHWC1996-10-10
432431671451299K960711ACUMED BONE GRAFT SYSTEMKIJ1996-05-07
432432063404636K952330EXTERNAL FIXATORJEC1995-10-05
432431456186772K951740INTRAMEDULARY FIXATION RODHSB1995-08-11
432431356562095K951673ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIESHSB1995-07-06
432431680121690K944330ACUTRAK PLUS FIXATION SYSTEMHWC1995-05-05
432431940195182K943857EXTERNAL FIXATORJEC1995-01-27
432431202742783K942603ORTHOPAEDIC WIRESLRN1994-11-09
432431492062649K942359BONE PLATE SYSTEMHRS1995-04-13
432431019090667K942341CANNULATED CANCELLOUS BONE SCREWHWC1994-12-05
432431820494137K942340CORTICAL BONE SCREWHWC1994-12-05
432431027690944K933361ACUMED RADIUS RODHSB1994-02-22
432431084910806K931246CERCLAGE WIRE CRIMP SLEEVEJDQ1994-02-22
432431676110316K931244BONE PLATEHRS1994-02-15
432431768940161K931244BONE PLATEHRS1994-02-15
432431215922797K930834ACUTRACTHWC1993-07-26
432431696996954K921480OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEMJDQ1992-06-26
432431159584555K920666INTRAMEDULARY FIXATION RODHSB1992-08-05
432432008058209K915613BONE SCREW 3.5 MMHWC1992-02-13
2088701906951234K251296The Acumed Wrist Fixation SystemHRS2025-06-18
432431906951234K251296The Acumed Wrist Fixation SystemHRS2025-06-18
2088701003703125K251132The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - ScrewsHRS2025-07-14
432431003703125K251132The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - ScrewsHRS2025-07-14
432431266582705K250297TECHFIT Patient-Specific Cranial SystemGWO2025-10-27
432431916662917K243624Acu-Sinch Knotless MiniHTN2025-01-23
2088701916662917K243624Acu-Sinch Knotless MiniHTN2025-01-23
432431741727017K242263TECHFIT DISRP® SystemDZJ2024-12-11
432431780696606K233311Acumed Wrist Plating SystemHRS2024-04-22
432431259215399K230744Acumed Acutrak 3 Headless Compression Screw SystemHWC2023-06-09
432431645343768K230276TECHFIT DISRP® SystemDZJ2023-06-23
432431506318416K222577TECHFIT Diagnostic ModelsLLZ2023-01-06
432431827383148K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalHWC2022-12-29
432431831760753K220892ExsoMed INnate NanoTM Lag Screw SystemHWC2022-04-27
432431497105839K212990Acumed Ankle Syndesmosis Repair SystemHTN2022-01-07
432431466348967K210750Acumed Clavicle Hook Plating SystemHRS2021-07-15
432431203731509K203282TECHFIT Patient-Specific Maxillofacial SystemJEY2021-05-19
432431829233692K201430InFrame™ Cannulated Fixation SystemHWC2020-06-20
432431741922415K192473Exsomed Wrist Plating SystemHRS2019-12-03
432431829515567K183603INnate Cannulated Screw SystemHWC2019-03-12
432431769205973K171558ExsoMed ITN Cannulated Screw SystemHWC2017-09-01
432431911962738K171407ExsoMed ArcPhix and ExsoMed ArrowPhixHWC2017-08-18
432431650020741K161334RASL Repair KitHWC2017-02-09
432431036960964K151886Acumed Ankle and Small Fragment Base Set UpdateHRS2015-10-30
432431246738609K143394Acumed Small Fragment Base SetHRS2015-01-23
432431594297845K143385Acumed Ankle Plating SystemHRS2015-04-06
432431713303988K143276Acumed Small Bone IM Nail SystemHSB2015-02-05
432431761249518K141383ACUMED HAND FRACTURE SYSTEMHRS2014-06-13
432431091757017K140925ACUMED SUTURE ANCHOR SYSTEMMBI2014-05-20
432431369897486K133469ACUMED SUTURE ANCHOR SYSTEMMBI2014-03-10
432431799490339K131845ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOCKWI2013-09-30
432431064393303K131764ACUMED WRIST SPANNING PLATEHRS2013-09-05
432431239986203K131636POLARUS CONNECTLXT2013-10-10
432431634784597K131380ACUMED TOTALW RIST FUSION PLATING SYSTEMHRS2013-06-10
432431833010854K130986FRAG-LOC SYSTEMHTN2013-07-23
432431412980608K123890ACUMED CANNULATED SCREW SYSTEMHWC2013-03-18
432431842490361K122538ACUMED PELVIC BONE PLATE SYSTEMHRS2012-11-19
432431671856166K120903CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATEHRS2012-07-13
432431733087797K120163ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEMHRS2012-02-17
432431678905433K113318ACUTE INNOVATIONS MODULAR RIBLOC SYSTEMHRS2012-01-12
432431031157556K112111ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHORHTN2011-11-14
432431419105788K111608SLIC SCREW REPAIR SYSTEMHWC2011-08-29
432431533485703K102998CONGRUENT BONE PLATE SYSTEMHRS2011-01-04
432432058908496K102387MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIESJDR2011-10-24
432431488831288K101170ACUTE INNOVATIONS STERNAL FIXATION SYSTEMKTT2010-09-17
432431869799383K100123ACUMED WRIST ARTHRODESIS PLATE SYSTEMHRS2010-10-06
432431468927392K083144ACUMED CLAVICLE SCREW SYSTEMJDW2009-06-16
432431486905751K071715ACUMED CONGRUENT BONE PLATE SYSTEMHRS2007-07-18
432431769339849K071616ARC SURGICAL BIOTRAK PIN SYSTEMHTY2007-12-19
432431289940076K063244ARC SURGICAL BONE REDUCTION SCREWHWC2006-12-27
432431014512602K061763ARC SURGICAL BIOTRAK SCREWHWC2006-09-19
432431605219884K051083ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEMHRS2005-05-12
432431528245919K043176ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEMHWC2005-06-17
432432047440164K041858ACUMED ANATOMIC RADIAL HEAD SYSTEMKWI2004-10-05
432431858427678K033639ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEMHWC2004-01-15
432431013742272K031438ACUMED SMALL BONE LOCKING ROD SYSTEM IIHSB2003-07-17
432431943583470K021321WRIST FUSION PLATEHRS2002-07-17
432431492805567K013616POLARUS CAP SCREWHSB2001-12-19
432431017291667K012655CONGRUENT BONE PLATE SYSTEMHRS2001-11-07
432431092422348
352101096844785
432431117608647
432431135811250
432431463847878
2088701624923557
432431624923557
432431738933443
432431742019601
432431793401065
432431827037446
432431833592733
432432004674597

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS262025-07-14
HWC202023-06-09
HSB72015-02-05
HTN52025-01-23
MBI32014-05-20
JEC31997-02-19
DZJ22024-12-11
KWI22013-09-30
HTY22007-12-19
JDQ21994-02-22
GWO12025-10-27
LLZ12023-01-06
JEY12021-05-19
LXT12013-10-10
JDR12011-10-24
KTT12010-09-17
JDW12009-06-16
HSD12000-02-04
KIJ11996-05-07
LRN11994-11-09

PMN#

200 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next