FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Hematology ×
3,294 results
3289–3294 of 3,294
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Jul 20, 1976
AUTO CELL DILUENT
K760124 · GIF
Bd Becton Dickinson Vacutainer...
Hematology · 22d
Cleared Jul 20, 1976
SALINE, ISOTONIC BUFFERED, AZIDE-FREE
K760129 · GIF
Harleco
Hematology · 22d
Cleared Jul 20, 1976
AGGREGOMETER, DUAL CHANNEL PLATELET
K760159 · JBX
Chrono-Log Corp.
Hematology · 18d
Cleared Jul 19, 1976
KIT, PLATELET AGGREGATION REAGENT (#390)
K760198 · GHR
Chrono-Log Corp.
Hematology · 13d
Cleared Jul 16, 1976
BLOOD WARMER (CODE 4R4305)
K760012 · BSB
Travenol Laboratories, S.A.
Hematology · 36d
Cleared Jul 16, 1976
TRAY, BLOOD SAMPLING (PULSATOR II)
K760086 · GJE
Concord Laboratories, Inc.
Hematology · 25d