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
159505–159528 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 22, 1982
P6S ATHLETIC
K821449 · IPF
Squire, Sanders & Dempsey
Physical Medicine · 69d
Cleared Jul 22, 1982
PROFLEX
K821672 · HRX
Utah Medical Products, Inc.
Orthopedic · 43d
Cleared Jul 22, 1982
ARTHROLUX ARTHROSCOPE
K821694 · HRX
Arthro-Tech, Inc.
Orthopedic · 44d
Cleared Jul 22, 1982
RAPIDO-LASTIC IN STERILE FORM
K821701 · EFQ
Conco Medical Co.
General & Plastic Surgery · 44d
Cleared Jul 22, 1982
MI DAS 1000 AUTOMATIC SLIDE STAINER
K821830 · KPA
Innovative Medical Systems, Inc.
Hematology · 30d
Cleared Jul 22, 1982
I.M. ARTHROSCOPE
K821847 · HRX
Instrument Makar, Inc.
Orthopedic · 30d
Cleared Jul 22, 1982
U-100 BAG
K821853 · KNX
Medical Technologies of Georgia
Gastroenterology & Urology · 29d
Cleared Jul 22, 1982
U-200 BAG
K821854 · KNX
Medical Technologies of Georgia
Gastroenterology & Urology · 29d
Cleared Jul 22, 1982
NEIDENT*
K821907 · JTO
Analytical Products, Inc.
Microbiology · 24d
Cleared Jul 22, 1982
ZETA-CORT
K821931 · CGR
Amf Biological and Diagnostics Co.
Chemistry · 23d
Cleared Jul 22, 1982
TANDEM HCG IMMUNOEZYMETRIC ASSAY KIT
K821944 · JHI
Hybritech, Inc.
Chemistry · 23d
Cleared Jul 22, 1982
96 WELL DISPENSER
K821961 · JTC
Skatron, Inc.
Microbiology · 21d
Cleared Jul 22, 1982
125I QUICK-MB TEST KIT FOR QUANTITATION
K821964 · JHT
Intl. Immunoassay Laboratories, Inc.
Chemistry · 21d
Cleared Jul 22, 1982
GRAMSTAIN SET
K821977 · HYI
Granite Diagnostics, Inc.
Pathology · 16d
Cleared Jul 22, 1982
TITAN GEL CPK/LDH ISOENZYME CONTROL
K821981 · JJT
Helena Laboratories
Chemistry · 16d
Cleared Jul 22, 1982
QUANTIMETRIC 2 C-REACTIVE PROTEIN REAG.
K821984 · DCK
Kallestad Laboratories, Inc.
Immunology · 16d
Cleared Jul 22, 1982
BACILLU S SUBTILIS BIOLOGICAL INDICA.
K822024 · FRC
Findley Research, Inc.
General Hospital · 13d
Cleared Jul 22, 1982
H-H NERVE ROOT RETRACTOR
K822048 · HAO
Holter-Hausner Intl.
Neurology · 10d
Cleared Jul 22, 1982
SHOW'RBAG
K822059 · LGF
The Healthcare Group Laboratories, Inc.
Orthopedic · 9d
Cleared Jul 22, 1982
OCULAR BIOMETER 4000
K827035
Radionics Medical, Inc.
Radiology · 90d
Cleared Jul 22, 1982
MODEL 712 MICROMANIPULATOR
K827607
Laser Industries , Ltd.
Radiology · 48d
Cleared Jul 22, 1982
DELTASCAN HPS CT SCANNER
K827644
Technicare Corp.
Radiology · 28d
Cleared Jul 22, 1982
SUNTANNING BOOTH
K827666
Carribean Connection
Radiology · 21d
Cleared Jul 21, 1982
TP440 ORTHOPROBE
K821571 · GZJ
Grove Video Corp.
Neurology · 55d