FDA.report

KAREN PARKER

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30002704503000270450KAREN PARKER1N2026-01-011302 WRIGHTS LANE E West Chester PA US 19380
30081149653008114965Karen Parker1N2026-01-014600 Riverside Dr Palm Beach Gardens FL US 33410
30094179013009417901KAREN PARKER1N2026-01-011302 WRIGHTS LANE E West Chester PA US 19380
30135101783013510178KAREN PARKER1N2026-01-011302 WRIGHTS LANE E West Chester PA US 19380
30137303283013730328Karen Parker1N2026-01-011302 Wrights Ln E West Chester PA US 19380
30094508633009450863Karen Parker1N2020-04-251302 Wrights Ln E West Chester PA US 19380

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1116911628201802P990040TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEMKGG2000-09-25
239031256494846P960025BRANTIGEN I/F CAGE(R) USED WITH VSP(R) SPINE PLATES AND PEDICLE SCREWSMAX1999-02-02
1116911307563675P960025BRANTIGEN I/F CAGE(R) USED WITH VSP(R) SPINE PLATES AND PEDICLE SCREWSMAX1999-02-02
1116911735987343P890055MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEMLKK1996-03-11
1403821865773856P050010PRODISC -L TOTAL DISC REPLACEMENT DEVICEMJO2006-08-14
239031091750361K994364SYNTHES BUTTON PLATEMBI2000-03-15
1403821091750361K994364SYNTHES BUTTON PLATEMBI2000-03-15
239031179110603K994187SYNTHES CERVIFIX SYSTEMKWP1999-12-21
1403821179110603K994187SYNTHES CERVIFIX SYSTEMKWP1999-12-21
239031675561040K994121SMALL STATURE USSMNI2000-10-17
1403821675561040K994121SMALL STATURE USSMNI2000-10-17
1403821742969500K993335SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEMHTO2000-06-12
239031100181742K993314SYNTHES LIGHT GUIDEFQP1999-12-06
1403821100181742K993314SYNTHES LIGHT GUIDEFQP1999-12-06
1116911253745128K993266PROWLER PLUS INFUSION CATHETERKRA1999-10-28
1116911423210581K993099BREMER HALO SYSTEM TITANIUM SKULL PINJEC1999-12-15
239031857750012K993099BREMER HALO SYSTEM TITANIUM SKULL PINJEC1999-12-15
1116911674471038K992898THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEMGZT1999-10-21
239031793570648K992898THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEMGZT1999-10-21
1403821326577086K992891SYNTHES CERCLAGE POSITIONING PINJDQ1999-11-02
1403821954276913K9928373.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATED LC-ABP)KTW1999-10-25
239032068722905K992739CLICK'XMNH2000-02-08
1403822068722905K992739CLICK'XMNH2000-02-08
1403821085241906K992617HEX BUTTONHTN1999-10-27
1403822045876478K992616SDB CERCLAGE SYSTEMJDQ1999-10-27
1403821821489732K992348SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)JDS1999-09-23
1116911566543017K992168MOSS MIAMI 6.35MM POLYAXIAL SCREWKWQ1999-09-23
239031925954485K992168MOSS MIAMI 6.35MM POLYAXIAL SCREWKWQ1999-09-23
239031388207961K992000SYNTHES CRANIAL FLAP TUBE CLAMPGXN1999-07-20
1403821388207961K992000SYNTHES CRANIAL FLAP TUBE CLAMPGXN1999-07-20
1403821133634387K991552SYNTHES PEDIATRIC ROD SYSTEMMNH1999-06-02
1403821761980143K991407SYNTHES LOCKING CALCANEAL PLATESLXT1999-06-11
1403822048516549K991089SYNTHES CERVIFIX SYSTEMKWP1999-08-27
239031186478782K990965SYNTHES CERVIFIX SYSTEMKWP1999-07-01
1403821186478782K990965SYNTHES CERVIFIX SYSTEMKWP1999-07-01
239031055507609K990745MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEMMNI1999-03-30
1403821055507609K990745MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEMMNI1999-03-30
239031391542326K990637SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEADNEI1999-10-22
1403821391542326K990637SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEADNEI1999-10-22
239031209133005K984612SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEMMNI1999-01-19
1403821209133005K984612SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEMMNI1999-01-19
1403822039183133K984498SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEMKTT1999-02-18
1403821469116123K984377SYNTHES SPINE CERVIFIX SYSTEMKWP1999-01-21
239031180560299K984350VSP SYSTEMMNI1999-01-20
239031784424818K984348TIMX LOW BACK SYSTEMMNI1999-01-20
1116911890417389K984348TIMX LOW BACK SYSTEMMNI1999-01-20
1403821929012597K983787SYNTHES PROXIMAL TIBIA PLATING SYSTEMHRS1999-01-21
1403821241105458K983766SYNTHES SYNMESHEZX1998-12-18
239031034675434K983583DEPUY ACROMED MOSS AND MOSS MIAMI SPINAL SYSTEMSKWP1998-12-03
239031195584599K983530SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEMKWP1998-12-16
1403821195584599K983530SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEMKWP1998-12-16
1403821738982604K983485SYNTHES 1.3 MM SELF-DRILLING SCREWDZL1998-12-21
239031791837902K982987SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEMMNI1998-10-21
1403821791837902K982987SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEMMNI1998-10-21
1403821894380736K982732SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS)HRS1998-10-08
239031845994854K982483DEPUY MOTECH PEAK FIXATION SYSTEMHRS1998-09-14
1403821273782046K982322SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEMKWP1998-11-25
1403821823155610K982222SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEMHWC1998-07-29
1403821843920300K981890SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATESJEY1998-08-18
1403821657478417K981757SYNTHES (USA) DHS HELIX SYSTEMJDO1998-07-17
1116911448690392K981751SINUSCOPE AND ACCESSORIESEOB1998-08-13
239031272400404K981362SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTORDZL1998-06-29
1301011272400404K981362SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTORDZL1998-06-29
1403821272400404K981362SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTORDZL1998-06-29
1403821996707315K981275SYNTHES (USA) RATCHETING DISTRACTORMQN1998-06-25
239031397734951K981113PEDIATRIC PRCMNH1998-05-29
239031532872978K980928SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEMKWP1998-05-11
1403821532872978K980928SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEMKWP1998-05-11
239031816942914K980761SYNTHES SPINE PEDIATRIC ROD SYSTEMMNH1998-08-04
1403821816942914K980761SYNTHES SPINE PEDIATRIC ROD SYSTEMMNH1998-08-04
239031216238662K980485ISOLA SPINAL SYSTEMMNI1998-10-21
239031966457558K980368DEPUY MOTECH PEAK 3MM FIXATION ROD SYSTEMHRS1998-04-14
1403821078296307K980358SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEMKWP1998-04-16
239032022294409K980199SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWSDZL1998-04-17
1403822022294409K980199SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWSDZL1998-04-17
239031822073355K974908SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATESHRS1998-03-18
1403821822073355K974908SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATESHRS1998-03-18
239031583916622K974757KANEDA ANTERIOR SCOLIOSIS SYSTEM KASSKWQ1998-03-05
1116911215719090K974573DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEMKWP1998-02-18
1403821440326040K974555SYNTHES 2.0 MM LOCKING PLATE SYSTEM (2.0 LPS)JEY1998-03-03
1403821955964918K974554SYNTHES RESORBABLE FIXATION SYSTEMJEY1998-02-24
1403821250702500K974537SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEMKTT1998-02-18
1403821934979809K974525SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEMKWQ1998-03-02
1116911056616334K974341MITEK BTB ABSORBABLE (PLA) CROSS PINHTY1998-04-16
1116911697467172K974291MITEK BTB ABSORBABLE (PLA) CROSS PINHTY1998-03-05
1403821964420863K974025ANSPACH SHIELDED ATTACHMENTGFF1998-07-06
1116911467193726K973060DEPUY MOTECH PROFILE ANTERIOR THORACOLUMBAR PLATE SYSTEMKWQ1997-11-03
239031839584758K973060DEPUY MOTECH PROFILE ANTERIOR THORACOLUMBAR PLATE SYSTEMKWQ1997-11-03
239031543106612K973018SYNTHES MINI LENGTHENING APPARATUSMQN1997-11-10

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
HRS2802026-03-09
NKB1662025-10-21
KWQ1162017-07-20
HWC1012018-11-21
KWP962014-10-01
KTT822023-07-26
HSB652024-08-01
MNH652008-06-27
MNI582012-02-01
MAX532023-03-08
JEY512020-09-10
MQP392019-05-23
HCG272022-07-14
JDS252020-09-03
MQN252017-05-08
LXT252007-03-07
MAI212025-02-05
NKG202023-11-09
MBI202023-10-06
KTW202001-09-06
DZL192005-04-06
OLO182026-03-27
OVE172012-07-25
HRX142022-10-18
JDQ142011-07-28
NDN122013-05-20
MQV102011-01-27
OVD92015-08-21
JDW92004-04-12
DQY82019-11-08
NEI82008-09-05
JEC82007-08-24
KRA72022-04-12
GXQ72022-01-28
HTN72020-04-06
JDR72015-05-11
HTY72013-05-17
GZT72012-01-27
NQW72010-01-07
DQO72009-11-20