FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
167617–167640 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 04, 1980
AP-1 AUTO PROGRAMMER
K792590 · IOL
Burdick Corp.
Physical Medicine · 18d
Cleared Jan 04, 1980
STRESS TABLE/ERGOMETER SYSTEM
K792591 · ISD
Victoreen, Inc.
Radiology · 18d
Cleared Jan 04, 1980
DISPOSABLE INCENTIVE SPIROMETER
K792598 · BWF
Hospitak, Inc.
Anesthesiology · 17d
Cleared Jan 04, 1980
TEGTMEIER MAMMOMETER
K792608
Aztec Medical Products, Inc.
General & Plastic Surgery · 17d
Cleared Jan 04, 1980
SENTRY
K792653 · DXN
Automated Screening Devices
Cardiovascular · 9d
Cleared Jan 04, 1980
DATABASE MANAGEMENT & REPORTING SYSTEM
K792677 · DQK
Honeywell, Inc.
Cardiovascular · 8d
Cleared Dec 31, 1979
AGGLUTINOTEST-INFECTIOUS MONONUCLEOSIS
K791455 · KTN
Volu Sol Medical Industries
Immunology · 147d
Cleared Dec 31, 1979
AGGLUTINOTEST-THYROGLOBULIN
K791458 · JZO
Volu Sol Medical Industries
Immunology · 147d
Cleared Dec 31, 1979
AGGLUTINOTEST-C-REACTIVE PROTEIN
K791461 · DCK
Volu Sol Medical Industries
Immunology · 147d
Cleared Dec 31, 1979
AGGLUTINOTEST-RHEUMATOID ARTHRITIS
K791507 · DHR
Volu Sol Medical Industries
Immunology · 152d
Cleared Dec 31, 1979
AVL MODEL 940 AUTOMATIC PH/BLOOD GAS
K792230 · CHL
Gauntlet Technology Corp.
Chemistry · 56d
Cleared Dec 31, 1979
SANDARE CYANMETHEMOGLOBIN STANDARD
K792358 · KRZ
Sandare Chemical Co., Inc.
Hematology · 40d
Cleared Dec 31, 1979
HANSAPOR STERILE
K792360 · FPX
Beiersdorf, Inc.
General & Plastic Surgery · 40d
Cleared Dec 31, 1979
SIM MEDIUM
K792420 · JSE
Isle Media and Sterile Products, Inc.
Microbiology · 34d
Cleared Dec 31, 1979
DECARBOXYLASE BROTH BASE WITH OR WITH-
K792421 · JSH
Isle Media and Sterile Products, Inc.
Microbiology · 34d
Cleared Dec 31, 1979
TETRATHIONATE BROTH BASE
K792422 · JSJ
Isle Media and Sterile Products, Inc.
Microbiology · 34d
Cleared Dec 31, 1979
CENTRIA FERRITIN RIA
K792449 · DBF
Union Carbide Corp.
Immunology · 31d
Cleared Dec 31, 1979
PLATELET-CHEX FOR BLOOD CENTERS
K792467 · JPK
Streck Laboratories, Inc.
Hematology · 28d
Cleared Dec 31, 1979
HELENA FACTOR IX DEFICIENT SUBSTRATE
K792475 · GGP
Helena Laboratories
Hematology · 28d
Cleared Dec 31, 1979
HELENA FACTOR XI DEFICIENT SUBSTRATE
K792476 · GGP
Helena Laboratories
Hematology · 28d
Cleared Dec 31, 1979
CULTURE PLATES & TUBED MEDIA
K792481 · JTZ
Laboratory Products, Inc.
Microbiology · 42d
Cleared Dec 31, 1979
SERACON-SRI
K792485 · JIX
Bhp Diagnostix, Inc.
Chemistry · 28d
Cleared Dec 31, 1979
SERACON-SRI (PROD. # D029
K792486 · JIX
Bhp Diagnostix, Inc.
Chemistry · 28d
Cleared Dec 31, 1979
SERACON-SRII
K792487 · JIX
Bhp Diagnostix, Inc.
Chemistry · 28d