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
173689–173712 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 16, 1977
CATHETER INTRODUCER KIT
K770427 · DYB
Electro-Catheter Corp.
Cardiovascular · 9d
Cleared Mar 16, 1977
CANNULAE, AORTIC, ARCH, HIGH FLOW
K770429 · DWF
3M Health Care, Sarns
Cardiovascular · 9d
Cleared Mar 16, 1977
CATHETER, CURVED LEFT HEART VENT
K770430 · DWF
3M Health Care, Sarns
Cardiovascular · 9d
Cleared Mar 16, 1977
CATHETER, TWO STAGE VENOUS RETURN
K770431 · DWF
3M Health Care, Sarns
Cardiovascular · 9d
Cleared Mar 16, 1977
MICROFLUSH
K770432 · KRA
Medex, Inc.
Cardiovascular · 9d
Cleared Mar 16, 1977
ANESTHESIA KIT, EPIDURAL BLOCK, CONTINU.
K770461 · CAZ
Arrow Intl., Inc.
Anesthesiology · 7d
Cleared Mar 16, 1977
CUTTER TUNGSTEN CARBIDE BURS
K770469 · EJL
Cutter Laboratories, Inc.
Dental · 6d
Cleared Mar 16, 1977
PRESSURE TRANSDUCER ISOLATER CODE 5ML6L2
K770475 · KOC
Travenol Laboratories, S.A.
Gastroenterology & Urology · 5d
Cleared Mar 15, 1977
MYOTRON
K761350 · HCC
Somatronics, Inc.
Neurology · 77d
Cleared Mar 15, 1977
0.22/UM FILTERSET W/Y-INJECTION SITE
K770182 · FPB
Abbott Laboratories
General Hospital · 47d
Cleared Mar 15, 1977
MONITORING KIT, CENTRAL VENOUS PRESSURE
K770290 · DQO
Argon Medical Corp.
Cardiovascular · 29d
Cleared Mar 15, 1977
SHIELD, DENTAL X-RAY, PROTECTIVE
K770407 · IWO
Worldwide Dental, Inc.
Radiology · 11d
Cleared Mar 15, 1977
KARAYA GUM POWDER, OSTOMY
K770408 · EZK
Howmedica Corp.
Gastroenterology & Urology · 11d
Cleared Mar 15, 1977
OXYGEN MANIFOLD SYSTEMS, NITROUS OXIDE
K770426 · CAM
Bel-Med, Inc.
Anesthesiology · 8d
Cleared Mar 15, 1977
IMPLANT, DENTAL, PYROLITE CARBON ENDO.
K770440 · DZE
General Atomic Co.
Dental · 8d
Cleared Mar 15, 1977
EPC INSTICKS
K770447 · GXY
Stimulation Technology, Inc.
Neurology · 7d
Cleared Mar 15, 1977
INS - T.E.N.S.
K770448 · GXY
Stimulation Technology, Inc.
Neurology · 7d
Cleared Mar 14, 1977
SPECIMEN COLLECTOR
K770112 · FMH
Portex, Inc.
General Hospital · 54d
Cleared Mar 14, 1977
I.V. LOK TM
K770119 · KMK
Jelco Laboratories
General Hospital · 52d
Cleared Mar 14, 1977
DISPOS-A-CARE THERMOMETER SHEATH
K770125 · FLK
Chesebrough-Pond'S U.S.A. Co.
General Hospital · 52d
Cleared Mar 14, 1977
RH CONTROL DILUENT
K770185 · KSZ
Bd Becton Dickinson Vacutainer...
Hematology · 46d
Cleared Mar 14, 1977
FRACTURE REDUCTION SYS., MODEL OR 1001
K770388 · JEC
Sisan Assoc.
Orthopedic · 14d
Cleared Mar 14, 1977
LENS SET, MENTOR TRIAL
K770389 · HPC
Codman & Shurtleff, Inc.
Ophthalmic · 14d
Cleared Mar 14, 1977
FORCEPS, ANKLE INSERTING, CON-AXIAL
K770420 · HSN
Depuy, Inc.
Orthopedic · 7d