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
154441–154464 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 04, 1984
ASPIRATING HANDLE W/BACKFLUSHING CAPAB
K832560
Precision Medical Instruments, Inc.
Gastroenterology & Urology · 156d
Cleared Jan 04, 1984
OSCAR COLOUR VISION TESTER
K832843 · HIT
Keeler Instruments, Inc.
Ophthalmic · 135d
Cleared Jan 04, 1984
STORZ EXTRA
K833064 · HQC
Storz Instrument Co.
Ophthalmic · 118d
Cleared Jan 04, 1984
DISPOSABLE OCUTOME PROBE
K833371 · HQE
CooperVision, Inc.
Ophthalmic · 99d
Cleared Jan 04, 1984
CLERZ LUBRICATING/REWETTING SOLUTION
K833494 · HKX
CooperVision, Inc.
Ophthalmic · 89d
Cleared Jan 04, 1984
TITANGEL HIGH RESOLUTION CONTROL
K833639 · JJY
Helena Laboratories
Chemistry · 79d
Cleared Jan 04, 1984
ACA THYROXINE UPTAKE CALIBRATOR
K833702 · JIT
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 78d
Cleared Jan 04, 1984
COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE
K833708 · LKZ
Worthington Diagnostic Systems
Hematology · 76d
Cleared Jan 04, 1984
RIACOAT T-4
K833745 · CDX
Immuno Assay Corp.
Chemistry · 70d
Cleared Jan 04, 1984
TESTING VISUAL ACUITY
K833778 · HOX
Technical Enginuities Co.
Ophthalmic · 69d
Cleared Jan 04, 1984
BEECHER 20 GA. PROBE
K833800 · HQC
Beecher Medical Diagnostic...
Ophthalmic · 65d
Cleared Jan 04, 1984
MACHEMER/TANO ROTATING
K833820 · HRJ
Optical Micro Systems, Inc.
Ophthalmic · 63d
Cleared Jan 04, 1984
IL TEST IGG IGA & IGM KITS
K833841 · CZK
Instrumentation Laboratory CO
Chemistry · 58d
Cleared Jan 04, 1984
MAST INHALANT PROFILE
K833885 · DHB
Mast Immunosystems
Immunology · 56d
Cleared Jan 04, 1984
DOT VISUAL ACVITY TEST 2000
K833956 · HOX
Good-Lite Co.
Ophthalmic · 49d
Cleared Jan 04, 1984
MAST TOTAL IGE
K833969 · DGC
Mast Immunosystems
Immunology · 49d
Cleared Jan 04, 1984
ANTINUCLEAR ANTIBODY IMMUNOLOGICAL
K833984 · KTL
Intl. Diagnostic Technology
Immunology · 48d
Cleared Jan 04, 1984
TINSDALE ENRICHMENT
K834066 · JSK
Remel Co.
Microbiology · 40d
Cleared Jan 04, 1984
TRACH MATE
K834265 · JAY
Tempe Biomedical, Inc.
Anesthesiology · 27d
Cleared Jan 04, 1984
BI-PLANE DIGITAL FLUOROGRAPHY DFX7000
K834286 · JAA
Adac Laboratories
Radiology · 40d
Cleared Jan 03, 1984
THERAPEUTIC EXCHANGE SYSTEM
K831423 · LQQ
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 245d
Cleared Jan 03, 1984
PLASTIC LEG BAG
K831530 · KNX
Forever-Dry, Inc.
Gastroenterology & Urology · 236d
Cleared Jan 03, 1984
COVERUPS
K831703 · NAD
The Urology Group
General & Plastic Surgery · 223d
Cleared Jan 03, 1984
BARD ABSORPTION DRESSING
K831710 · FRO
C.R. Bard, Inc.
General & Plastic Surgery · 221d