FDA Tracker
Every catheter 510(k), the day FDA posts it.
Live from openFDA. Refreshed daily. Free, no account, no rate limit. Drop any clearance into Compass as a predicate candidate when you have a tenant.
510(k)
Sponsor
Class
Cleared
K181546
Intuit Medical Products, LLC
I
2020-01-03
K190525
Acclarent, Inc.
I
2019-05-03
K162729
Cook Incorporated
I
2017-08-11
K161698
Acclarent, Inc.
I
2016-10-24
K150800
B.Braun Medical, Inc.
I
2015-11-12
K143738
Intuit Medical Products, LLC
I
2015-08-27
K112562
Kimberly-Clark
I
2011-12-15
K111254
Acclarent, Inc.
I
2011-08-22
K073041
Acclarent, Inc.
I
2008-03-11
K061903
Acclarent, Inc.
I
2006-08-18
K043527
Exploramed Nc1, Inc.
I
2005-04-05
K041995
Uresil, LLC
I
2004-08-19
K021632
Uresil, L.P.
I
2002-06-13
K982945
Spirit Medical Systems, Inc.
I
1998-09-22
K981910
Ni-Med, Inc.
I
1998-08-24
K974146
Allegiance Healthcare Corp.
I
1998-01-28
K973656
Specialty Surgical Products, Inc.
I
1997-11-18
K972922
Interview Medical Technology Corp.
I
1997-10-08
K973199
Amsino Intl., Inc.
I
1997-09-10
K964219
Goulter Medical, Inc.
I
1997-08-11
K972100
Advanced Care Medical Products
I
1997-07-31
K972078
Boston Medical Products, Inc.
I
1997-07-10
K972076
Boston Medical Products, Inc.
I
1997-06-26
K972077
Boston Medical Products, Inc.
I
1997-06-26
K971411
Bentec Medical, Inc.
I
1997-06-03
K970966
Sierra Laboratories, Inc.
I
1997-04-22
K962900
Hollister, Inc.
I
1996-09-16
K962413
Sierra Laboratories, Inc.
I
1996-07-15
K962384
Sierra Laboratories, Inc.
I
1996-07-15
K960426
Medical Components, Inc.
I
1996-03-21
K955505
Navarre Biomedical , Ltd.
I
1996-02-07
K955018
Instrumentarium Corp.
I
1996-01-30
K953226
Premium Plastics, Inc.
I
1995-08-08
K952082
Rochester Medical Corp.
I
1995-07-18
K951506
Trinity Laboratories, Inc.
I
1995-07-03
K945994
Universal Medical Products, Inc.
I
1995-06-21
K951907
Navarre Biomedical , Ltd.
I
1995-05-15
K951475
Navarre Biomedical , Ltd.
I
1995-04-24
K920849
Tonometrics, Inc.
I
1995-03-17
K950439
Becton Dickinson Vascular Access, Inc.
I
1995-03-14
K950437
Becton Dickinson Vascular Access, Inc.
I
1995-03-14
K945554
Ultracell Medical Technologies, Inc.
I
1995-02-17
K944379
Regulatory & Marketing Services, Inc.
I
1995-02-15
K944378
Regulatory & Marketing Services, Inc.
I
1995-02-15
K946243
Coloplast A/S
I
1995-02-13
K945556
Ultracell Medical Technologies, Inc.
I
1995-01-18
K944790
Applied Medical Resources
I
1994-11-29
K943718
Merocel Corp.
I
1994-09-16
K942335
American Catheter
I
1994-08-09
K925243
Deknatel, Inc.
I
1994-07-27
K940269
Hollister, Inc.
I
1994-06-02
K934419
Urological Associates of Central Jersey P.A.
I
1994-05-25
K934266
Sierra Laboratories, Inc.
I
1994-04-19
K933510
Sherwood Medical Co.
I
1994-02-24
K935252
K-Lok, Inc.
I
1994-02-18
K932391
Navarre Biomedical , Ltd.
I
1994-01-27
K932205
Wilson-Cook Medical, Inc.
I
1994-01-03
K934391
Radionics, Inc.
I
1993-11-19
K932228
Boston Scientific Corp
I
1993-08-10
K926217
Terumo Medical Corp.
I
1993-07-13
K930225
K-Lok, Inc.
I
1993-04-21
K925176
Boston Scientific Corp
I
1993-04-08
K924981
Taut, Inc.
I
1993-04-06
K924128
Applied Medical Resources
I
1993-02-10
K922148
Sherwood Medical Co.
I
1992-12-07
K923136
Rochester Medical Corp.
I
1992-12-03
K924567
Ansley Medical Products, Inc.
I
1992-11-23
K921199
Smith & Nephew Richards, Inc.
I
1992-07-08
K921511
Intersurgical, Inc.
I
1992-06-17
K913817
Synectics-Dantec
I
1992-06-11
K914315
Medical Dynamics, Inc.
I
1992-03-04
K913542
Intl. Medical Devices , Ltd.
I
1992-01-21
K913678
Medovations, Inc.
I
1991-12-16
K913524
Mentor Corp.
I
1991-10-04
K903480
Un-I-Med, Inc.
I
1991-10-01
K912645
Atrium Medical Corp.
I
1991-09-13
K912109
Uresil Corp.
I
1991-08-12
K912211
Inman Liebelt Corp.
I
1991-08-09
K911825
Tonometrics, Inc.
I
1991-07-23
K911421
Intersurgical, Inc.
I
1991-06-24
K911294
Dhd Diemolding Healthcare Div.
I
1991-06-10
K910908
Vygon Corp.
I
1991-05-20
K902420
Gainor Medical Europe, Ltd.
I
1991-04-17
K903552
Concord Protex
I
1991-01-02
K902093
Amg Medical Equipments, Inc.
I
1990-10-23
K903669
General Medical Co.
I
1990-09-12
K902814
Orion Life Systems, Inc.
I
1990-08-17
K900583
Bivona Medical Technologies
I
1990-08-09
K901310
Invotec International, Inc.
I
1990-06-14
K895735
Deseret Medical, Inc.
I
1990-05-18
K896730
Unoplast A/S
I
1990-03-30
K897128
Universal Medical Instrument Corp.
I
1990-03-01
K896797
Westmark, Sterile Packing Systems, Inc. (Sps)
I
1990-02-16
K895772
Exel Intl.
I
1990-02-16
K895993
Vitaphore Corp.
I
1990-01-11
K895868
Baxter Healthcare Corp
I
1989-10-31
K895041
Medical Dynamics, Inc.
I
1989-10-16
K892450
Quinton, Inc.
I
1989-10-11
K891410
Sensatronix Medical Systems, Inc.
I
1989-06-23
K893462
Atheus Corp.
I
1989-06-08
live · openFDA · refreshed daily
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