Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
158617–158640 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 1983
COLORIMETERS SERIES ONE 12
K830101 · JJQ
Innotron of Oregon, Inc.
Chemistry · 17d
Cleared Jan 28, 1983
SERUM IRON DIAGNOSTIC TEST KITS
K830104 · CEM
Sclavo, Inc.
Chemistry · 17d
Cleared Jan 28, 1983
NEEDLE CATHETER JEJUNOSTOMY KIT
K830119 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 17d
Cleared Jan 28, 1983
ARTERIAL BLOOD FILTER AF-1025-AF-1025BL
K830131 · DTM
American Bentley
Cardiovascular · 16d
Cleared Jan 28, 1983
ARTERIAL BLOOD FILTER AF-1040-AF-1040BL
K830132 · DTM
American Bentley
Cardiovascular · 16d
Cleared Jan 27, 1983
INTRACATH-DA INTRAVENOUS CATH. PLACEMENT
K823064 · DQO
Parke-Davis Co.
Cardiovascular · 101d
Cleared Jan 27, 1983
UVB LIGHT BOX TANNING BOOTH
K837032
Sun Shanty, Inc.
Radiology · 64d
Cleared Jan 26, 1983
SIGMA 7000
K820038 · FRN
Sigma
General Hospital · 19d
Cleared Jan 26, 1983
MODEL 460 INTERMITTENT MEDICATION DELIV
K823018 · FLN
Y
General Hospital · 105d
Cleared Jan 26, 1983
MEDISYSTEMS FISTULA NEEDLES
K823068 · KOC
Medisystems Corp.
Gastroenterology & Urology · 99d
Cleared Jan 26, 1983
M2100 ANTEPARTUM FETAL MONITOR
K823081 · HGM
Huntleigh Technology, Inc.
Obstetrics & Gynecology · 99d
Cleared Jan 26, 1983
M2000 INTRAPARTUM FETAL MONITOR
K823188 · HGM
Huntleigh Technology, Inc.
Obstetrics & Gynecology · 92d
Cleared Jan 26, 1983
MODEL 78670A
K823268 · LDD
Hewlett-Packard Co.
Cardiovascular · 85d
Cleared Jan 26, 1983
PC-205 TENCKHOFF CATHETER ROD OBTURATOR
K823296 · FKX
Medigroup
Gastroenterology & Urology · 82d
Cleared Jan 26, 1983
QUILL CATHETER GUIDE
K823303 · FKX
Medigroup
Gastroenterology & Urology · 82d
Cleared Jan 26, 1983
DIALATORS PC-203 & 202
K823330 · FKX
Medigroup
Gastroenterology & Urology · 79d
Cleared Jan 26, 1983
PC-204 TUNNELOR
K823331 · FKX
Medigroup
Gastroenterology & Urology · 79d
Cleared Jan 26, 1983
PC 201A LOCKING SLEEVE
K823390 · FKX
Medigroup
Gastroenterology & Urology · 82d
Cleared Jan 26, 1983
POUR BOTTLE DECANTER #2010
K823538 · KPE
Medi-Plant Intl.
General Hospital · 57d
Cleared Jan 26, 1983
MICRO Z BLOOD COLLECTING NEEDLES
K823696 · FMI
Hospital Products Co.
Chemistry · 49d
Cleared Jan 26, 1983
BICEPS ELECTROCAUTERY SYSTEM
K823755 · HAM
Squibb Diagnostics
General & Plastic Surgery · 43d
Cleared Jan 26, 1983
EVERBOND GLASS IONOMER CEMENT
K823795 · EMA
Sybron Corp.
Dental · 30d
Cleared Jan 26, 1983
IMPRA PERITONEAL CATHETER
K823857 · FKX
Impra, Inc.
Gastroenterology & Urology · 35d
Cleared Jan 26, 1983
SOFT GRIP UNI-HANDLE
K823913 · EJB
Treace Medical, Inc.
Dental · 29d