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
146689–146712 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 19, 1985
NITTO SURGICAL CLOTH TAPE ST-330
K853645 · KGX
Nitto Denko America, Inc.
General & Plastic Surgery · 16d
Cleared Sep 19, 1985
NITTO SURGICAL NON-WOVEN TAPE ST-320
K853646 · KGX
Nitto Denko America, Inc.
General & Plastic Surgery · 16d
Cleared Sep 19, 1985
NITTO SURGICAL PAPER TAPE ST-310
K853647 · KGX
Nitto Denko America, Inc.
General & Plastic Surgery · 16d
Cleared Sep 19, 1985
AUTO SUTURE TITANIUM HEMOSTATIC CLIP
K853650 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 16d
Cleared Sep 19, 1985
NEW JERSEY MODULAR FEMORAL HIP
K853655 · JDI
Depuy, Inc.
Orthopedic · 16d
Cleared Sep 19, 1985
MOUNT TUBE RADIOGRAPHIC
K853682 · IYB
X-Ray Systems
Radiology · 15d
Cleared Sep 19, 1985
MIC-CONCEPT VIEWBOX
K853745 · LIB
Microtech Medical Systems, Inc.
Microbiology · 10d
Cleared Sep 19, 1985
MSI-HB HEMOGLOBIN CONTROL
K853776 · JPK
Medical Specialties, Inc.
Hematology · 9d
Cleared Sep 18, 1985
S-ROM 135 FEMORAL STEM & COLLAR(PART OF S-ROM HIP
K851422 · JDI
Joint Medical Products Corp.
Orthopedic · 161d
Cleared Sep 18, 1985
TIP TOLEDO INCISOR PROTECTOR
K851640 · BRW
Edward O. Goodwich
Anesthesiology · 160d
Cleared Sep 18, 1985
NEWPORT VENTILATOR MODEL E-100
K852108
Newport Medical Instruments, Inc.
Cardiovascular · 126d
Cleared Sep 18, 1985
CLS HIP PROSTHESIS
K852517 · JDI
Advanced Biosearch Assn.
Orthopedic · 97d
Cleared Sep 18, 1985
OXY-DIAL
K852618 · BYF
Ashai Co. , Ltd.
Anesthesiology · 90d
Cleared Sep 18, 1985
OXY-ONE
K852623 · BYG
Ashai Co. , Ltd.
Anesthesiology · 90d
Cleared Sep 18, 1985
OXY-TWO
K852624 · BYG
Ashai Co. , Ltd.
Anesthesiology · 90d
Cleared Sep 18, 1985
OXY-TUBE
K852625 · CAT
Ashai Co. , Ltd.
Anesthesiology · 90d
Cleared Sep 18, 1985
AERO-MASK ONE
K852626 · BYG
Ashai Co. , Ltd.
Anesthesiology · 90d
Cleared Sep 18, 1985
NASAL ONE
K852628 · CAT
Ashai Co. , Ltd.
Anesthesiology · 90d
Cleared Sep 18, 1985
AERO-MASK TWO
K852629 · BYG
Ashai Co. , Ltd.
Anesthesiology · 90d
Cleared Sep 18, 1985
HUMPHREY FIELD ANALYZER MODEL 630
K852639 · HPT
Zeiss Humphrey System
Ophthalmic · 90d
Cleared Sep 18, 1985
ALGO I
K852687 · GWJ
Algotek, Inc.
Neurology · 85d
Cleared Sep 18, 1985
BAYLOR RAPID AUTOTRANSFUSION SYSTEM
K852736 · CAC
Cardio Systems, Inc.
Anesthesiology · 133d
Cleared Sep 18, 1985
MCGHAN TISSUE EXPANDER FILL KIT
K853014 · LCJ
Mcghan Medical Corp.
General & Plastic Surgery · 63d
Cleared Sep 18, 1985
LIFELINC LEADWIRE
K853303 · BZQ
Tronomed, Inc.
Anesthesiology · 43d