FDA Tracker
Every diagnostic 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
K063675
Diagnostic Hybrids, Inc.
I
2007-09-24
K051114
Sentinel Ch. Srl
I
2005-11-25
K050352
Ameritek Research, LLC
I
2005-09-01
K050063
Asymmetrx
I
2005-02-09
K020226
Hellen Professional Services
I
2002-08-22
K991677
London International Group, Inc.
I
2000-04-12
K980541
Barco NV Display Systems
I
1998-04-09
K974721
Bayer Corp.
I
1998-03-03
K971514
London International Group, Inc.
I
1997-10-29
K963080
Bayer Corp.
I
1996-09-27
K952075
Bayer Corp.
I
1995-06-13
K951360
Bayer Corp.
I
1995-05-02
K950353
Miles, Inc.
I
1995-04-20
K930500
Dimensional Medicine, Inc.
I
1993-12-29
K931026
Medical Illumination, Inc.
I
1993-08-19
K931604
3M Health Care, Ltd.
I
1993-07-21
K931605
3M Health Care, Ltd.
I
1993-07-20
K930074
Horizon Diagnostics, Inc.
I
1993-05-11
K923071
Life-Tech Intl., Inc.
I
1992-09-28
K922964
King Diagnostics, Inc.
I
1992-08-18
K921278
Metecon, Inc.
I
1992-05-18
K914171
Tech Intl. Co.
I
1991-12-18
K904416
Biotrax, Inc.
I
1991-06-24
K904458
London Diagnostics, Inc.
I
1990-10-12
K902443
London Diagnostics, Inc.
I
1990-08-02
K900543
Abbott Laboratories
I
1990-05-03
K873121
General Electric Co.
I
1988-08-23
K874544
Molecular Biosystems, Inc.
I
1988-08-12
K881894
Cambridge Bioscience Corp.
I
1988-07-08
K882269
Storz Instrument Co.
I
1988-06-23
K873670
Molecular Biosystems, Inc.
I
1988-06-08
K873565
Molecular Biosystems, Inc.
I
1988-05-13
K880524
Fischer Imaging Corp.
I
1988-05-04
K880522
Fischer Imaging Corp.
I
1988-05-04
K880521
Fischer Imaging Corp.
I
1988-05-04
K880523
Fischer Imaging Corp.
I
1988-05-04
K880532
Fischer Imaging Corp.
I
1988-03-28
K880218
Binax, Inc.
I
1988-03-01
K875248
Bioscan Instruments, Inc.
I
1988-02-24
K871878
Gen-Probe, Inc.
I
1987-10-28
K871795
Gen-Probe, Inc.
I
1987-07-30
K864842
Abbott Laboratories
I
1987-04-29
K864597
Gen-Probe, Inc.
I
1987-04-20
K862806
Amatech International, Inc.
I
1986-12-04
K855234
Oxoid U.S.A., Inc.
I
1986-11-04
K855235
Oxoid U.S.A., Inc.
I
1986-11-04
K855236
Oxoid U.S.A., Inc.
I
1986-11-04
K855233
Oxoid U.S.A., Inc.
I
1986-11-04
K863240
Abbott Laboratories
I
1986-09-29
K862692
Ocular Instruments, Inc.
I
1986-08-21
K860003
Leeco Diagnostics, Inc.
I
1986-03-17
K853848
Medical Graphics Corp.
I
1985-12-05
K852969
Cambridge Bioscience Corp.
I
1985-11-05
K852701
Allied Fisher Scientific
I
1985-07-19
K850823
Philips Medical Systems (Cleveland), Inc.
I
1985-04-10
K844476
Portable Medical Laboratories, Inc.
I
1985-03-13
K850056
Leeco Diagnostics, Inc.
I
1985-02-06
K844442
Portable Medical Laboratories, Inc.
I
1985-02-01
K842505
Abbott Laboratories
I
1984-08-07
K834145
American Ergo Systems
I
1984-03-16
K834465
Cirs, Inc.
I
1984-02-21
K830512
Leeco Diagnostics, Inc.
I
1983-04-05
K830288
Sclavo, Inc.
I
1983-02-25
K821302
Biomedia, Inc.
I
1982-06-01
K821301
Biomedia, Inc.
I
1982-06-01
K820863
Isle Media and Sterile Products, Inc.
I
1982-04-16
K820797
Biomedica, Inc.
I
1982-04-08
K820039
Leeco Diagnostics, Inc.
I
1982-01-22
K813509
Oxoid U.S.A., Inc.
I
1981-12-31
K812434
Diagnostica, Inc.
I
1981-09-23
K812004
Abbott Laboratories
I
1981-07-28
K811954
Immuno Assay Corp.
I
1981-07-27
K811725
Immuno Assay Corp.
I
1981-07-10
K810662
Leeco Diagnostics, Inc.
I
1981-03-31
K810663
Leeco Diagnostics, Inc.
I
1981-03-27
K810381
Abbott Laboratories
I
1981-02-26
K810054
Robert I. Chien & Assoc., Inc.
I
1981-01-28
K803001
Leeco Diagnostics, Inc.
I
1981-01-02
K802278
Supelco, Inc.
I
1980-11-24
K802496
Oxoid U.S.A., Inc.
I
1980-11-12
K802497
Oxoid U.S.A., Inc.
I
1980-11-12
K801898
Connecticut Diagnostics, Ltd.
I
1980-10-10
K800813
Diagnostic Products Corp.
I
1980-04-24
K770428
Holco Instrument Corp.
I
1979-09-12
K790281
Analytical Products, Inc.
I
1979-03-21
K782159
Leeco Diagnostics, Inc.
I
1979-02-01
K770506
Norwood Scientific Associates, Inc.
I
1977-05-06
K760972
Taylor Instrument Analytics Co.
I
1977-01-26
K761090
Technicon Instruments Corp.
I
1976-12-02
K760509
Medcraft Corp.
I
1976-08-30
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