FDA.reportPublic FDA data

BIOPRO, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
18335061832656BIOPRO, INC.1Y2026-01-012929 Lapeer Rd PORT HURON MI US 48060
30100844883010084488BIOPROD D.O.O.1N2026-01-01Stegne 11 Ljubljana SI 1521
30142852313014285231BIOPROTECT LTD.1N2026-01-01Ha Gavish 6 Netanya Central IL 4250706
97103151000282513BIOPRO (M) SDN BHD1N2020-04-25LOT14, PT.4204 LINGKARN SULTN HISHAMUDDIN, NO. PRT. INDU. PORT KLANG Selangor MY 42000

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
528451595783621K994281BIOPRO, NITRILE, CORRECT TOUCH NITRILE POWDER FREE EXAMINATION GLOVES (GRREN, PURPLE)LZA2000-10-20
528451987271659K994276BIOPRO, NITRILON, CORRECT TOUCH- NITRILE POWDERED EXAMINATION GLOVES (GREEN/ PURPLE)LZA2000-10-20
528452027453967K994043CORRECT TOUCH LATEX POWDERED EXAMINATION GLOVESLYY2000-01-11
528451690226735K992358CORRECT TOUCH POWDER FREE 911 LATEX EXAMINATION GLOVES, (BLUE)LYY1999-09-10
430221188624785K992144BIOPRO RIMMED ACETABULAR COMPOMENTLZO1999-09-22
430221273069598K990821PROVIDENCE CUP SYSTEMJDI1999-04-29
528451404691801K981333NITRILON CORRECT-TOUCHLZA1998-06-22
528451215819824K981304NITRILON CORRECT-TOUCHLZA1998-06-22
430222072709072K964472RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENTKYI1997-02-03
430221280267259K963433THREADED FIXATION PINJDW1996-11-06
430222072542416K961157WHITESIDE BIOMECHANICS CANCELLOUS BONE SCREWHWC1996-05-17
528451093378352K960467POWDER FREE LATEX EXAMINATION GLOVELYY1996-05-24
430221622750537K955916TOWNLEY TOTAL ELBOW SYSTEMJDC1996-08-08
430221058679790K954768BIOPRO HEMI-ENDO MODULAR CERAMIC HEADLZO1996-01-18
430221685147489K953045BIOPRO HEMI-ENDO MODULAR CERAMIC HEADLZO1995-09-27
430222043997682K925682BIOPRO ZIRALLOY MODULAR FEMORAL HEADS, MODIFIEDLZO1994-01-07
430221472066423K922841BIOPRO MODULAR TIBIAL TRAYJWH1993-09-21
430221293672202K922500PSL TOTAL HIP REPLACEMENT SYSTEMLPH1994-01-07
430221539917095K912641BIOPRO ZIRALLOY MODULAR FEMORAL HEADSLZO1991-11-27
430221281399103K904448TOWNLEY TOTAL KNEE (TTK)JWH1991-07-17
430221629004734K895886BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEMKWL1989-12-01
430221666185540K890044BIOPRO ANATOMIC UNICOMPARTMENTAL KNEEHRY1989-11-06
430221876699180K882869TOWNLEY COX COMB ACETABULAR COMPONENTJDI1988-10-14
430221786424549K872856BIOPRO 32MM BALLJDI1987-08-17
430221650900143K242121mBôs (Monogram mBôs TKA System)OLO2025-03-14
3199291073978033K222972BioProtect Balloon Implant™ SystemOVB2023-08-25
430221290239141K191297iNSitu Bipolar Hip SystemKWY2019-09-17
430221551918146K173013WishBone K-Wire SystemHTY2017-12-14
430221590266335K163627Shotel Ankle Arthrodesis Nail SystemHSB2017-09-14
430221828396694K162674BioPro Foot Plating SystemsHRS2017-06-16
430221867787099K150693PHIN-FX Cannulated Lag Screw SystemHWC2015-10-13
430221511289401K132510BIOPRO - INFINITY PLATE ANCHOR SYSTEMHTN2013-10-24
430221749974176K130298BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEMJDW2013-06-18
430221469088060K121973BIOPRO HEMI-EDGE TOE SYSTEMKWD2012-10-30
430221257585436K101030MODIFICATION TO HBS HEADLESS BONE SCREWHWC2010-06-03
430222055402844K100761BIOPRO POLAR HEADKWY2010-12-03
430221586936916K090208BIOPRO FEMORAL HEADSJDI2009-05-22
430221243062120K083490BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685HTY2009-03-18
430221739809349K082468APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)KWY2009-02-18
430221896398679K081149BIOPRO GO-EZ SCREWHWC2008-08-05
430221823898906K072298BIOPRO MEMORY STAPLE, MODELS 18062-18073JDR2007-10-29
430221229441692K061798BIOPRO MEMORY STAPLEJDR2006-08-21
430221999860274K061089MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599KYI2006-06-20
430221455432178K052596MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507KYI2005-11-15
430221925833229K043542BIOPRO TARA FEMORAL RESURFACING COMPONENTKXA2005-05-18
430221147169025K041936BIOPRO SUBTALAR IMPLANTHWC2004-09-08
430221882279921K041595TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870KWD2004-11-12
430221689491884K020791HBS HEADLESS BONE SCREWHWC2002-06-06
430221723741567K001046BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTSKWS2000-06-08
1501971591614412BK060010
1501971562650613BK050033
430221062041697
430221401045213
430221633647713
430221645239965
430221675429889
430221925907189
430221029127456
430221053881230
430221057774673
430221083525947
430221110388303
430221111440730
430221156520663
430221175609658
430221188291661
430221189150555
430221209039671
430221209846081
430221234555010
430221290239141
430221310469253
430221313184071
1501971318862921
430221390755738
430221405139652
430221421759396
430221440514655
430221441069409
430221453826680
430221464897798
430221476504087
430221507272858
430221535878178
430221544561291
430221553295616
430221565699876
430221568756438
430221573442024
430221591181371
430221622982941
430221647836940
430221701056664
430221707810849
430221731213821
430221734739408
430221739769418
430221742641510
430221753023647
430221753813378
430221756704575
430221818889724
430221954990817
430221991429993
430222036449534
430222054392415

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HWC62015-10-13
LZO51999-09-22
JDI42009-05-22
LZA42000-10-20
KWY32019-09-17
KYI32006-06-20
LYY32000-01-11
HTY22017-12-14
JDW22013-06-18
KWD22012-10-30
JDR22007-10-29
LPH21994-01-07
JWH21993-09-21
OLO12025-03-14
OVB12023-08-25
HSB12017-09-14
HRS12017-06-16
HTN12013-10-24
KXA12005-05-18
KWS12000-06-08
JDC11996-08-08
KWL11989-12-01
HRY11989-11-06

PMN#

47 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next