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
160897–160920 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 10, 1982
CDX 200
K820035 · BZM
Cdx Corp.
Anesthesiology · 62d
Cleared Mar 10, 1982
COBE ACUFLEX FSN, #15-208
K820237 · LFK
Cobe Laboratories, Inc.
Gastroenterology & Urology · 41d
Cleared Mar 10, 1982
COBE ACUFLEX SSN, #15-220
K820238 · LFJ
Cobe Laboratories, Inc.
Gastroenterology & Urology · 41d
Cleared Mar 10, 1982
MONOJECTOR MONOLET LANCER
K820333 · FMK
Sherwood Medical Co.
General & Plastic Surgery · 30d
Cleared Mar 10, 1982
PILLING IDENTI-LOOPS
K820377 · GAD
Narco Scientific
General & Plastic Surgery · 29d
Cleared Mar 10, 1982
SUTURE REMOVAL TRAY
K820423 · KDD
Megaplast, Inc.
General & Plastic Surgery · 22d
Cleared Mar 10, 1982
ARGYLE PVC FEEDING TUBE
K820441 · KNT
Sherwood Medical Co.
Gastroenterology & Urology · 20d
Cleared Mar 10, 1982
ARGYLE INDWELL FEEDING TUBE
K820442 · KNT
Sherwood Medical Co.
Gastroenterology & Urology · 20d
Cleared Mar 10, 1982
DEEP CONVEX FACE PLATE
K820493 · EXB
Smith'S Ostomy Products, Inc.
Gastroenterology & Urology · 15d
Cleared Mar 10, 1982
CONSTRUCTA FOAM
K820517
Alimed, Inc.
Physical Medicine · 13d
Cleared Mar 08, 1982
BX-400 JESSE JIMBODY
K813410 · IPF
Bloomex International, Inc.
Physical Medicine · 94d
Cleared Mar 08, 1982
BX-400 SPORT
K813443 · IPF
Bloomex International, Inc.
Physical Medicine · 89d
Cleared Mar 08, 1982
OMNI STIM II
K813604 · IPF
Omni Intl., Inc.
Physical Medicine · 70d
Cleared Mar 08, 1982
MODEL 450XL CO2 SURGICAL LASER
K820327 · GEX
Lumenis, Inc.
General & Plastic Surgery · 28d
Cleared Mar 08, 1982
ROWE SHOULDER INSTR. FOR BANKHART REPAIR
K820344 · HTD
New England Surgical Instrument Corp.
General & Plastic Surgery · 28d
Cleared Mar 08, 1982
HOT MINI 15 & HOT MINI 24
K820359 · IMD
Hot Mini International, Inc.
Physical Medicine · 27d
Cleared Mar 08, 1982
DISPOSABLE SURGICAL GARMENTS
K820363 · FYA
Alphamedix, Inc.
General Hospital · 27d
Cleared Mar 08, 1982
LD-L TRIS SYSTEM PACK TEST
K820378 · CFJ
Boehringer Mannheim Corp.
Chemistry · 27d
Cleared Mar 08, 1982
LIQUIZYME CO2REAGENT SET
K820388 · JFL
American Research Products Co.
Chemistry · 26d
Cleared Mar 08, 1982
ABUSCREEN RADIOIMMUNOASSAY FOR CANNABI
K820391 · LAT
Hoffmann-La Roche, Inc.
Toxicology · 26d
Cleared Mar 08, 1982
TECHNICON RA-1000 SYSTEM ADD. ANALYT
K820394 · CKA
Technicon Instruments Corp.
Chemistry · 25d
Cleared Mar 08, 1982
LIQUIZYME CHLORIDE REAGENT
K820411 · JFS
American Research Products Co.
Chemistry · 24d
Cleared Mar 08, 1982
TEMPERATURE TREND INDICATOR (TTI)
K820426 · KPD
Mon-A-Therm, Inc.
General Hospital · 20d
Cleared Mar 08, 1982
BAXA ADDISEAL
K820435 · KPE
Baxa Corp., Sub. of Cook Group, Inc.
General Hospital · 19d