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
166825–166848 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 1980
NIKKISO PARALLEL FLOW DIALYZERS
K801065 · FTG
Int'L Marketing & Sales Corp.
General & Plastic Surgery · 93d
Cleared Aug 07, 1980
PALODENT MATRICES & BITINE RINGS
K801142 · DZN
Alvin Meyer, D.D.S.
Dental · 86d
Cleared Aug 07, 1980
LOSEFF BALLOON TYPE SELF-RETENTION WOUND
K801349 · JCX
Loseff Medical Designers, Ltd.
General & Plastic Surgery · 59d
Cleared Aug 07, 1980
KOLD WRAP
K801365 · IME
Romaine, Inc.
Physical Medicine · 58d
Cleared Aug 07, 1980
MOM 2
K801607 · CCL
Neotronics, Inc.
Anesthesiology · 23d
Cleared Aug 07, 1980
RESTRAINT, PROTECTIVE
K801628 · IQK
The Owenby Co.
Physical Medicine · 23d
Cleared Aug 07, 1980
ELECTROCARDIOGRAPH, MODEL ECG-5503
K801677 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 16d
Cleared Aug 07, 1980
MODEL BP-200 INFANT PRESSURE VENTILATOR
K801697 · CBK
Bourns Medical Systems, Inc.
Anesthesiology · 15d
Cleared Aug 07, 1980
UNI-RECORD I
K801700 · DXH
Bd Becton Dickinson Vacutainer...
Cardiovascular · 14d
Cleared Aug 07, 1980
BAUER & BLACK RIGID WRIST BRACE
K801701 · IQI
Bd Becton Dickinson Vacutainer...
Physical Medicine · 14d
Cleared Aug 07, 1980
BK-1424 INNER LIP PLATE, CERAMIC
K801705 · ILC
Fred Sammons, Inc.
Physical Medicine · 14d
Cleared Aug 07, 1980
BK-1426-00-01 STONYBROOK/HI-WALL PLATE
K801706 · ILC
Fred Sammons, Inc.
Physical Medicine · 14d
Cleared Aug 07, 1980
BK-1520-01 ECONOMY WRIST SUPPORT, CHILD
K801708 · IQI
Fred Sammons, Inc.
Physical Medicine · 14d
Cleared Aug 07, 1980
BK-5058-01 QUAD-QUIP WHEELCHAIR CUFF
K801709 · KNO
Fred Sammons, Inc.
Physical Medicine · 14d
Cleared Aug 07, 1980
BK-5315-01 FOAM HAND EXERCISER, SMALL
K801710 · ION
Fred Sammons, Inc.
Physical Medicine · 14d
Cleared Aug 07, 1980
LUMBOSACRAL SUPPORTS & THORACO-LUMBO-SAC
K801712 · IPY
Fred Sammons, Inc.
Physical Medicine · 14d
Cleared Aug 07, 1980
BK-6157-02 C.V.A SLING, MEDIUM&LARGE
K801713 · ILI
Fred Sammons, Inc.
Physical Medicine · 14d
Cleared Aug 07, 1980
TRANS DISTAL JOINT FINGER EXTEN. SPLINT
K801714 · ILH
Fred Sammons, Inc.
Physical Medicine · 14d
Cleared Aug 07, 1980
CURITY PARACERVICAL/PUDENDAL BLOCK ANES
K801724 · CAZ
The Kendal Co.
Anesthesiology · 14d
Cleared Aug 07, 1980
PRISMA-FIL
K801732 · EBF
Dentsply Intl.
Dental · 13d
Cleared Aug 07, 1980
PLASTAZOTE SHOE
K801743 · KNP
Alimed, Inc.
Physical Medicine · 10d
Cleared Aug 07, 1980
ARTERIAL BUBBLE TRAP
K801770 · DWF
Delta Medical Industries
Cardiovascular · 10d
Cleared Aug 07, 1980
COLD PACK #589
K801776 · IME
Sunbeam Corp.
Physical Medicine · 10d
Cleared Aug 07, 1980
OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT
K801779 · EMB
Oxy Dental Products, Inc.
Dental · 10d