FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
134281–134304 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 06, 1988
AMERLITE ENDOCRINOLOGY CONTROL SERA LAN.4190
K882728 · JJY
Amersham Corp.
Chemistry · 97d
Cleared Oct 06, 1988
LANTOR CUBE STERILIZER TEST PACK
K882756 · JOJ
Lantor Group
General Hospital · 93d
Cleared Oct 06, 1988
POLYSAFE IMPLANT. PACING LEADS W/TRABECULOK TIP
K883015 · DTB
Cardiac Control Systems, Inc.
Cardiovascular · 79d
Cleared Oct 06, 1988
USCI SOFT-TIP ANGIOGRAPHIC CATHETER
K883051 · DQO
C.R. Bard, Inc.
Cardiovascular · 79d
Cleared Oct 06, 1988
TRACE ELEMENTS SERUM TOXICOLOGY CONTROL
K883147 · JJY
Utak Laboratories, Inc.
Toxicology · 72d
Cleared Oct 06, 1988
HEWLETT-PACKARD MODLES 78354A/78352 PULSE OXIMETER
K883297 · DQA
Hewlett-Packard Co.
Anesthesiology · 63d
Cleared Oct 06, 1988
BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY
K883305 · CGJ
Binax, Inc.
Chemistry · 63d
Cleared Oct 06, 1988
BINAS LUTEINIZING HORMONE IRMA TEST KIT
K883306 · JIT
Binax, Inc.
Chemistry · 63d
Cleared Oct 06, 1988
FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI
K883352 · LJP
Whittaker Bioproducts, Inc.
Microbiology · 58d
Cleared Oct 06, 1988
CHLORIDE
K883386 · CHJ
Tech-Co, Inc.
Chemistry · 57d
Cleared Oct 06, 1988
DENTREK BRIDGE BARS
K883388 · EHO
Dale T. Dupuis
Dental · 57d
Cleared Oct 06, 1988
ALBABOND E
K883511 · EJS
Degussa Dental, Inc.
Dental · 50d
Cleared Oct 06, 1988
TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE
K883523 · DRO
Cardiotronics, Inc.
Cardiovascular · 50d
Cleared Oct 06, 1988
HISTO-CHECK LEGIONELLA CONTROL SLIDES
K883567 · LJG
Val Tech Diagnostics, Inc.
Microbiology · 45d
Cleared Oct 06, 1988
HISTO-CHECK ACID FAST SLIDES
K883568 · LJG
Val Tech Diagnostics, Inc.
Microbiology · 45d
Cleared Oct 06, 1988
HISTO-CHECK GRAM NEGATIVE SLIDES
K883569 · LJG
Val Tech Diagnostics, Inc.
Microbiology · 45d
Cleared Oct 06, 1988
HISTO-CHECK FUNGAL CONTROL SLIDES
K883570 · LJG
Val Tech Diagnostics, Inc.
Microbiology · 45d
Cleared Oct 06, 1988
HISTO-CHECK PARASITIC CONTROL SLIDES
K883571 · LJG
Val Tech Diagnostics, Inc.
Microbiology · 45d
Cleared Oct 06, 1988
FIRST MEDIC MODE 610
K883584 · MKJ
First Medical Devices Corp.
Cardiovascular · 45d
Cleared Oct 06, 1988
MODIFIED HCG IRMA KIT
K883639 · JHI
Pacific Biotech, Inc.
Chemistry · 42d
Cleared Oct 06, 1988
HEMOGLOBIN
K883683 · GJZ
Tech-Co, Inc.
Hematology · 38d
Cleared Oct 06, 1988
CLEARVIEW HCG
K883777 · JHI
Unipath , Ltd.
Chemistry · 30d
Cleared Oct 06, 1988
ORTHO* TOXOPLASMA-M ANTIBODY ELISA TEST
K883936 · LGD
Ortho Diagnostic Systems, Inc.
Microbiology · 17d
Cleared Oct 06, 1988
SNAP N' STAIN IRON STAIN
K884011 · GGH
Scientific Device Laboratory, Inc.
Pathology · 14d