FDA.report

Divya Raman

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
80404123009271244Divya Raman1N2026-01-013015 Carrington Mill Boulevard Morrisville NC US 27560
96807943003737899Divya Raman1N2026-01-013015 Carrington Mill Boulevard Morrisville NC US 27560
10005639401000563940Divya Raman1N2026-01-013015 Carrington Mill Boulevard Morrisville NC US 27560
30038983603003898360Divya Raman1N2026-01-013015 Carrington Mill Boulevard Morrisville NC US 27560
30071345203007134520Divya Raman1N2026-01-013015 Carrington Mill Boulevard Morrisville NC US 27560
30093079313009307931Divya Raman1N2026-01-013015 Carrington Mill Boulevard Morrisville NC US 27560
30188058243018805824Divya Raman1N2026-01-013015 Carrington Mill Boulevard Morrisville NC US 27560
30329165663032916566Divya Raman1N2026-01-013015 Carrington Mill Blvd Morrisville NC US 27560

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
228361440833666P180025MANTA Vascular Closure DeviceMGB2019-02-01
76831584152356K9939668FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETERDSP2000-02-18
76831955654461K99393314 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PROMPB2000-09-14
76861955654461K99393314 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PROMPB2000-09-14
228281080050838K993786RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGILL/MURPHYBTR2000-02-02
76831809284984K993691ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETERFOZ2000-03-08
76861809284984K993691ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETERFOZ2000-03-08
228361642142823K993191TFX MEDICAL INTRODUCER ASSEMBLYDYB2000-03-24
228361622323101K993157HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240FZP1999-12-17
228361890295485K992904MINI-PORTGBW1999-10-05
228361029403629K991580ILM ENDOTRACHEAL TUBEBTR2000-02-04
1511071029403629K991580ILM ENDOTRACHEAL TUBEBTR2000-02-04
76831668563411K991559MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELDFXX1999-08-23
76831563987254K99143114 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KITMPB1999-05-26
76861563987254K99143114 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KITMPB1999-05-26
76831050651565K990829ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65MCW1999-05-04
228281883395763K990619RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNCUFFED MURPHY/MAGILL, STERILEBTR1999-08-03
228361883395763K990619RUSCH REINFORCED ENDOTRACHEAL (OR TRACHEAL) TUBE- CUFFED AND UNCUFFED MURPHY/MAGILL, STERILEBTR1999-08-03
76832063264624K990236MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECTFOZ1999-08-20
76831728244403K984022PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KITMPB1999-05-18
76861728244403K984022PEDIATRIC TWO-LUMEN HEMODIALYSIS CATHERIZATION KITMPB1999-05-18
228361802383666K982313HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPSFZP1998-08-10
76831095373092K981660Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon CathetersDSP1998-10-16
76831006486615K980987BECTON DICKINSON SYRINGEFMF1998-06-11
76831067658730K980210VARIOUS SURGICAL OR PATIENT DRAPESKKX1998-05-15
76831525730794K980069VANISHPOINT SYRINGEMEG1998-02-12
228281175312418K972423RUSCH TRACHEOFIX-SETJOH1998-02-13
228281590040410K972184RUSCH BRILLANT SILICONE FOLEY CATHETEREZL1998-01-08
76832023235288K970864ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERSFOZ1997-10-17
76862023235288K970864ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERSFOZ1997-10-17
76831409046128K970855CLAVE CONNECTORFPA1997-06-24
76831282754616K970513GENERAL PURPOSE TRANDUCER COVERITX1997-06-20
76831160820983K970229ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SETDYB1998-02-13
76861160820983K970229ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SETDYB1998-02-13
228281913361049K965016ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)CAH1997-12-02
228361233256124K964719HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATORBTM1997-02-21
228281214697065K964382HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402)CAH1997-04-15
228361214697065K964382HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402)CAH1997-04-15
76831590769050K964142MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNSKKX1997-02-25
76831462899987K963257PERIPHERALLY INSERTED MEDLINE CATHETERLJS1997-03-04
76831709401650K962577ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETERFOZ1997-08-21
76861709401650K962577ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETERFOZ1997-08-21
228281064657218K962472RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETERFAP1996-08-27
76831943072842K962042GLASS SYRINGEFMF1996-10-08
228361101279516K961977KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBECBI1996-07-31
228281565440657K961914BACTERIA/VIRAL FILTERCAH1996-08-14
228281343412923K961840RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHYBTR1996-06-27
228361343412923K961840RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHYBTR1996-06-27
228281227178320K961837RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHYBTR1996-08-16
228361227178320K961837RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHYBTR1996-08-16
228361158414009K961150DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULACCK1996-09-10
76831864352679K960982MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULAFMI1996-12-23
228361103997166K960883INTRADUCER PERITONEAL CATHETER 6FRX3, 9FRX3 1/2, 10FRX4, 12FRX8GCJ1996-03-20
228361898856062K955495RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILEBTR1996-06-27
228281775896385K954828ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORTCAH1996-05-02
228361911902028K953963RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATIONBTS1995-11-27
76831333826208K953746ARROW HIGH FLOW FLUID ADMINSITRATION SET W/BLOOD FILTER & EXTENSION SETFPA1996-01-26
76831890006034K952861ANGIOCATH & INSYTE AUTOGUARD CATHETERSFOZ1995-07-31
228281367150613K952084HUMID-VENT FILTER PEDIBYD1995-06-12
76831303976207K951254SAFETYGLIDE NEEDLEFMI1995-10-07
228361586435039K951091RUSCH ENDOBRONCHIAL TUBE SETSBTS1995-06-08
76832046899166K950301ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERSFOZ1995-04-18
76831525690021K946173STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILKGAQ1995-01-09
76831841655507K945229ARROW MULTIPOLAR INTRACARDIAC ELECTRODE CATHETERSDRF1995-08-08
228361238927846K944552PILLING WECK M-20 DISPOSABLE AUTOMATIC HEMOCLIPFZP1994-11-07
76831314407258K944355NIPRO BRANDED DISPOSABLE SYRINGES, NEEDLESFMF1994-12-07
228361427393252K943719VISISTAT STAPLERGDT1994-08-24
76831887369824K940079ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903DYB1994-11-30
76861887369824K940079ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903DYB1994-11-30
228361968493552K935198GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONSKNT1994-09-28
76831099555211K935170CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSDQX1994-03-31
228281132174496K933597AQUA+TFILTERHME/THME/AQUA+TFILTERHCH/THCHBYD1993-11-01
76831969280430K931644GERTIE MARX NEEDLEBSP1993-09-22
76831754980459K931202STERILIZATION WRAP-STERISHEETFRG1993-12-16
228281776720784K931166RUSCH AGT PVC PREF ORAL TRACH TUBE, UNCUF W/MUR EYBTR1993-06-22
228281313255887K931165RUSCH AGT PVC PREF NASAL TRACH TUB/UNCUF W/MUR EYEBTR1993-06-22
228281013460909K931164RUSCH AGT PVC PREFORM NASAL TRACH TUB/CUF W/MUR EYBTR1993-06-23
228361013460909K931164RUSCH AGT PVC PREFORM NASAL TRACH TUB/CUF W/MUR EYBTR1993-06-23
228281396510086K931163RUSCH AGT PVC PREFORM ORAL TRACH TUB/CUF W/MUR EYEBTR1993-06-23
76831416549702K930826SUTURE NONABSORBABLE - SILKGAP1994-01-07
76831596490395K930825SUTURE NONABSORBABLE-NYLON,SILK,POLYESTER,STAINLESGAP1994-01-07
76831886116299K930129ARROW PICC-PERIPHERALLY INSERTED CENTRAL CATHETERLJS1994-03-28
76831816673745K925902B-D LOSS OF RESISTANCE SYRINGECAZ1993-01-14
228361222861158K925559BILIARY STONE DISLODGERLQR1992-12-17
76831195955124K925126INTERLINK(TM) INJECTION SITEFPA1993-06-18
76861195955124K925126INTERLINK(TM) INJECTION SITEFPA1993-06-18
76831387695659K924607ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SETDYB1993-04-22
76831176989150K924385NEW HYDROPHILIC COATING FOR WIRE GUIDESDQX1993-08-15
76861176989150K924385NEW HYDROPHILIC COATING FOR WIRE GUIDESDQX1993-08-15
228361220720538K923946CONCHATHERM IV HEATED MOLECULAR HUMIDIFIERBTT1994-10-18
76831190045940K923653NEEDLELESS INJECTION CANNULALJS1993-05-13
76831504510417K923127NEEDLE-PRO CARTRIDGEFMI1993-04-29
228361259339403K922894LAZER-TRACH TRACHEAL TUBEBTR1993-05-07
76831076496627K914531STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRESDQX1992-02-27
76861076496627K914531STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRESDQX1992-02-27
228361291809223K911260ATRAUMATIC STANDARD SPROTTE NEEDLEBSP1991-10-21
76831839565881K911260ATRAUMATIC STANDARD SPROTTE NEEDLEBSP1991-10-21
76831061301522K911202ATRAUMATIC STANDARD SPROTTE NEEDLEBSP1992-05-04
76831695365307K9101823M BRAND EAR LOOP FACE MASK, 2000FFXX1991-03-04
76831339135158K905229LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETSFGE1991-01-18
76831939658092K904021PNEUMOTHORAX KIT, MODIFICATIONJDC1990-10-09
76831470880327K903029STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTUREGAR1990-10-25
76832042417929K902327EMBOLECTOMY CATHETERDXE1991-02-25
228361741841267K901303HORIZON SURGICAL LIGATING AND MARKING CLIPDSS1990-06-05
76831596089108K900263ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETERFOZ1990-07-24
76861596089108K900263ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETERFOZ1990-07-24
228361015662656K897046LASER RESISTANT TRACHEAL TUBECBI1990-03-23
76831174626781K895516CAVITY DRAINAGE CATHETERIZATION SET, CS-01600GBX1989-12-27
76861174626781K895516CAVITY DRAINAGE CATHETERIZATION SET, CS-01600GBX1989-12-27
76831113684393K895417ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KITLFJ1990-01-03
76861113684393K895417ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KITLFJ1990-01-03
76831301431403K895268ARROW HANDS-OFF THERMO-PACEDQO1989-11-06
76831842564229K892530CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPHDYG1989-09-26
76831669896229K890959GUIDEWIREDQX1989-09-12
76831497490498K884552CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETERCAZ1989-03-14
76861497490498K884552CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETERCAZ1989-03-14
76831723632989K884490INTRODUCER SAFETY SYRINGEDQX1989-01-17
228361115897954K884150MODIFIED CONCHATHERM III CONTROLLED HEATERBTT1988-11-21
76831896953948K883905ARROW PNEUMOTHORAX KIT, AK-01500JOL1989-01-19
76831644821899K882724MICROTEK PROBE DRAPEKKX1988-08-03

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
FMI312023-07-25
BTR282025-04-29
DQY252022-08-18
FOZ232025-03-14
LJS232022-08-22
CAZ222023-02-13
FZP202025-07-03
DQX202024-09-18
DYB202016-07-05
KKX182010-11-09
MSD102014-07-07
FMF92011-12-14
BSP82019-08-21
CBI82018-11-02
GCJ82015-01-21
BTT72014-03-06
FPA72006-07-10
DSP62020-04-09
QSY62018-12-24
CAH62012-09-21
MPB62000-09-14
PEW52023-09-22
KOD52019-05-24
NGT52017-12-21
BSO52017-03-17
KNW52014-12-17
OBJ52014-07-08
EZL42024-08-01
GEI42018-10-12
GAP42008-06-09
FMG42002-10-18
DYG41989-09-26
POD32025-03-18
DQO32022-06-17
GBM32019-05-08
LIT32014-09-17
FYA32010-09-03
BYD31995-06-12
KGZ31980-10-23
PND22022-09-02