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

Filters: Cleared only ×
176,076 results
154513–154536 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 09, 1984
PROTOZOA STAIN CONTROL
K840517 · LJG
Scientific Device Laboratory, Inc.
Microbiology · 32d
Cleared Mar 09, 1984
DISPOS. LOW PRESS. CUFFED TRACHEOSTOMY
K840539 · BTO
Shiley, Inc.
Anesthesiology · 30d
Cleared Mar 09, 1984
LIQUI ZYME TOTAL BILIRUBIN REAGENT
K840564 · CIG
American Research Products Co.
Chemistry · 30d
Cleared Mar 09, 1984
TRI-TUBE RIA
K840589 · KHQ
Nuclear Medical Laboratories, Inc.
Chemistry · 29d
Cleared Mar 09, 1984
YERSINIA SUPPLEMENT
K840615 · JSI
Remel Co.
Microbiology · 25d
Cleared Mar 09, 1984
POIRIER COMMODES
K840639
Poirier S.A.
Physical Medicine · 49d
Cleared Mar 09, 1984
PARAMAX ALANINE AMINOTRANSFERASE
K840705 · CKA
American Dade
Hematology · 21d
Cleared Mar 08, 1984
ANTHROSCOPY SYSTEM
K834146 · HRX
Cabot Medical Corp.
Orthopedic · 98d
Cleared Mar 07, 1984
FOLEY CATHETERIZATION TRAY-VARIOUS
K832363 · KOD
Inmed Corp.
Gastroenterology & Urology · 233d
Cleared Mar 07, 1984
PHONATORY FUNCTION ANALYZER PS-77
K832678 · BXP
Kells Medical, Inc.
Anesthesiology · 211d
Cleared Mar 07, 1984
NO POUR BASIN
K840988
Concord Laboratories, Inc.
General Hospital
Cleared Mar 06, 1984
PORT-A-CATH IMPLANTABLE CATHETER SYS
K832906 · LLD
Pharmacia, Inc.
General Hospital · 190d
Cleared Mar 06, 1984
MESULIN INSULIN INFUSION SET
K833398 · FPA
Molnlycke A/S Hospital Products
General Hospital · 158d
Cleared Mar 06, 1984
HH SUBCUTANEOUS ACCESS PORT
K833672 · LKG
Holter-Hausner Intl.
General Hospital · 140d
Cleared Mar 06, 1984
MEDI-JECTOR II
K834044 · KZE
Derata Corp.
General Hospital · 104d
Cleared Mar 06, 1984
SILCATH
K834091 · LJS
Hdc Corp.
General Hospital · 99d
Cleared Mar 06, 1984
OP-CON SURG. INSTRUMENT #7
K834172 · EQN
Imm Enterprises , Ltd.
Ear, Nose, Throat · 106d
Cleared Mar 06, 1984
JAKOBI SURG. INSTRUMENTS #7 10/43
K834188 · JYL
Imm Enterprises , Ltd.
Ear, Nose, Throat · 106d
Cleared Mar 06, 1984
JAKOBI SURG. INSTRUMENTS #7 44/47
K834189 · EPY
Imm Enterprises , Ltd.
General & Plastic Surgery · 106d
Cleared Mar 06, 1984
JAKOBI SURG. INSTRUMENTS #8 15
K834190 · EMH
Imm Enterprises , Ltd.
Dental · 106d
Cleared Mar 06, 1984
CRYSTALLINE BONE SCREW ENDO-OSSEOUS
K834364 · DZE
C.B.S. Biotechnics, Inc.
Dental · 131d
Cleared Mar 06, 1984
SHOFU PORCELAIN STAIN
K834497 · EIH
Shofu Dental Corp.
Dental · 77d
Cleared Mar 06, 1984
OP-CON SURGICAL INSTRUMENT #9
K834540 · KBN
Imm Enterprises , Ltd.
Ear, Nose, Throat · 96d
Cleared Mar 06, 1984
HYPODERMIC SYRINGES & NEEDLES
K834548 · FMF
Cordis Corp.
General Hospital · 70d