FDA.reportPublic FDA data

OB

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
14225491000159999Oberg Medical - XL Division1N2026-01-014311 N. Normandy Ave. Chicago IL US 60634
30001629013000162901OBS Medical Ltd1N2026-01-01Unit 14 Cirencester Office Park Tetbury Road Cirencester Gloucestershire GB GL7 6JJ
30036399203003639920OBERG MEDICAL PRODUCTS COMPANY1N2026-01-01273 N Pike Rd Sarver PA US 16055
30077895613007789561OBP Medical Corporation1Y2026-01-01360 MERRIMACK STREET Building 9 Lawrence MA US 01843
30113105403011310540OBERON GMBH FIBER TECHNOLOGIES1N2026-01-01Ludwig-Witthoeft-Strasse 14 Wildau Brandenburg DE 15745
30114474473011447447OBBOMED GROUP LLC1Y2026-01-011210 E Lexington Ave Pomona CA US 91766
30134179383013417938Oberg Medical - Finishing Solutions1N2026-01-0110 Beaumont Rd Wallingford CT US 06492
30147246243014724624OBAGI COSMECEUTICALS LLC1Y2026-01-013760 Kilroy Airport Way Ste 500 Long Beach CA US 90806
30193857083019385708OBP SURGICAL CORPORATION1Y2026-01-01360 Merrimack Street BLDG 9 Lawrence MA US 01843
30254344623025434462Obsidio Inc1N2026-01-01Two Scimed Place Maple Grove MN US 55311
30083810883008381088OBJECT RESEARCH SYSTEMS (ORS) INC.1N2020-04-25760 St-Paul west suite 101 Montreal Quebec CA H3C1M4
30087743433008774343Oberg Costa Rica Limitada1N2020-04-25Edifico B-3 Zona Franca Metropolitana Barreal de Heredia Heredia CR 168-3006
30092568313009256831OBALON THERAPEUTICS, INC.1N2020-04-255421 Avenida Encinas Carlsbad CA US 92008
30096480723009648072OBrien Medical Company LLC1N2020-04-2516 Winterhaven Dr Orono ME US 04473
30129739063012973906OBESINOV CORP1Y2020-04-252007 15th street north Suite 100 Arlington VA US 22201
30133254963013325496OBER CONSULTING SP. Z O. O1N2020-04-25Brzechwy 6 POZNAN PL 60-195
30134009023013400902OBMEDICAL COMPANY1N2020-04-253630 SW 47th Ave Suite 201 Gainesville FL US 32608

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1442051362759660P160001OBALON BALLOON SYSTEMLTI2016-09-08
3121541318096860K242507OBSIDIO™ Conformable EmbolicKRD2024-10-03
2270541201616095K152890SACCADOMETER PLUS, SACCADOMETER ADVANCEDHLL2016-08-11
201591926236443K142807ANTHEM PS Total Knee SystemJWH2014-12-22
2346451515242112K142583LaborView LV1000OSP2015-01-16
1926101400716667K140555JOURNEY II BCS CONSTRAINED INSERTSJWH2014-05-29
1761741071756034K140470OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBERGEX2014-10-15
201591628579379K133947IRIX-A LUMBAR INTEGRATED FUSION SYSTEMOVD2014-07-29
1162881625052016K122429VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUALLLZ2012-11-28
201591296329154K122163CERTEX SPINAL IMPLANT SYSTEMMNI2012-10-31
201591582598860K121936NAVIOPFSOLO2012-11-30
887231815913140K121604ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHTFER2012-07-27
1926102003825980K121393SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATIONMBH2012-08-07
201591282715092K121349IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHERHWC2012-07-18
201591318423697K120832FORTEX PEDICLE SCREW SYSTEMMNH2012-10-23
201591811464811K120291OP SPINE SYSTEMOSH2012-04-16
201591961590802K111086ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEMHRS2011-06-17
201591878949984K110998AFFIRM (TM) VCF SYSTEMNDN2011-10-25
201591039215949K110959ORTHOPEDIATRICS BLADE PLATE SYSTEMHRS2011-08-05
208481210564502K110953VISENSIA, VISENSIA WITH ALERTMHX2011-06-15
201591706146434K101700IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEMHWC2010-10-12
201591152217378K101471AXLE INTERSPINOUS FUSION SYSTEMKWP2010-11-24
1162881203642265K100335ORS VISUALLLZ2010-04-08
201591286508701K100240ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEMHRS2010-05-17
201591055729892K092901EPICAGE INTERBODY FUSION DEVICEMAX2010-04-28
201591599090119K092561REJUVENATE MODULAR STEMMEH2009-10-20
201591244883524K092548EXTREMITY MEDICAL TRAPEZIUM PROSTHESISKYI2009-12-15
887231360145603K091937OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUMHIB2009-09-09
887231368629835K091838OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCKHIH2009-12-04
201591013255709K083726PEDINAIL INTRAMEDULLARY NAILING SYSTEMHSB2009-03-11
201591752788924K083637CALIX SPINAL IMPLANT SYSTEMODP2009-04-20
201591066597198K083286ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEMHRS2009-01-30
201591061563435K082949ORTHOPEDIATRICS BONE SCREWSHWC2008-11-25
201591751706420K082375ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEMHTY2008-10-17
201591094544134K081407ORTHOPEDIATRICS PEDIPLATES SYSTEMHRS2008-07-22
201591523798812K081097ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEMHTY2008-06-03
201591867270101K072943BUTREX BUTTRESS PLATING SYSTEMKWQ2008-01-28
201591107611974K052292SPIDER CERVICAL PLATING (SCP) SYSTEMKWQ2005-10-21
1998301182658848
2216411228088702
887231313132465
201591417560534
2216411486459777
1442051559099039
1434721941949654
1442051988828416
1434721992917501
201591994044844
201591027459963
201591050791263
1807721072691980
201591073994587
201591076616873
201591079670686
887231103521176
887231106310665
201591135222271
201591220883490
201591228088702
201591240913289
201591241105439
201591247231602
201591256154867
201591295584357
2216411295584357
201591296123027
2934001298981013
201591303317385
2216411303317385
201591309130204
201591336689759
201591337687515
2806541340421599
201591360012376
887231360930913
201591364303174
201591370523351
201591371230635
201591391859577
201591400716667
201591403329920
2806541411238687
201591443547055
1807721467786547
201591475995688
201591513687093
201591521777978
201591528232917
1807721619546707
201591633439055
201591640039307
1807721661004311
201591699870957
1807721700673938
887231703265652
201591713876135
201591733913492
201591815223891
201591852347785
201591928342165
201591975525440
201591990045456
201591996388211
201592003825980
201592031775898
201592045717085
201592058808831

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS52011-08-05
HWC32012-07-18
JWH22014-12-22
LLZ22012-11-28
HTY22008-10-17
KWQ22008-01-28
KRD12024-10-03
LTI12016-09-08
HLL12016-08-11
OSP12015-01-16
GEX12014-10-15
OVD12014-07-29
OLO12012-11-30
MNI12012-10-31
MNH12012-10-23
MBH12012-08-07
FER12012-07-27
OSH12012-04-16
NDN12011-10-25
MHX12011-06-15
KWP12010-11-24
MAX12010-04-28
KYI12009-12-15
HIH12009-12-04
MEH12009-10-20
HIB12009-09-09
ODP12009-04-20
HSB12009-03-11

NDC#

NU-DERM SUNFADER

Obagi Cosmeceuticals LLC

HYDROQUINONE, OCTINOXATE, and OXYBENZONE

50 records. Showing 1-40. Next

PMA#

57 records. Showing 1-40. Next

PMN#

GEM

2022-07-01

Obsidio, Inc.