FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
121465–121488 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 12, 1991
ANGIOPLASTY INFLATOR
K911295 · MAV
Vastek
Cardiovascular · 109d
Cleared Jul 12, 1991
INFINITY(TM) POROUS-COATED TROCHANTERIC MODULE
K911595 · JDG
Dow Corning Wright
Orthopedic · 94d
Cleared Jul 12, 1991
ROTATING HEMOSTATIC VALVE
K911678 · DYB
Devices For Vascular Intervention, Inc.
Cardiovascular · 88d
Cleared Jul 12, 1991
FLUIDSHIELD(TM) CONE CLASSIC(TM) II SURGICAL MASK
K911891 · FXX
Tecnol New Jersey Wound Care, Inc.
General Hospital · 74d
Cleared Jul 11, 1991
CENTAURI YAG LASER SYST, GYNECOLOGY
K904632 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 275d
Cleared Jul 11, 1991
COLOR DOPPLER OPTION TO AI 5200 DIAG ULTRASO SYST
K910212 · JYO
Acoustic Imaging Technologies Corp.
Radiology · 177d
Cleared Jul 11, 1991
SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER
K910429 · DXO
Baxter Healthcare Corp
Cardiovascular · 160d
Cleared Jul 11, 1991
HEMOGLOBIN REAGENT
K910745 · GKR
Toa Medical Electronics USA, Inc.
Hematology · 140d
Cleared Jul 11, 1991
COMFOR-DENT DENTURE LINER
K910795 · EBI
Comfort Acrylics Co.
Dental · 135d
Cleared Jul 11, 1991
REDFIELD INFRARED COAGULATOR
K911648 · KNS
Redfield Corp.
Gastroenterology & Urology · 90d
Cleared Jul 11, 1991
FETAL SCALP SPIRAL ELECTRODE
K911657 · HGP
Advanced Medical Systems, Inc.
Obstetrics & Gynecology · 90d
Cleared Jul 11, 1991
MEDICAL ASSEMBLIES ADULT ANESTHESIA BREATH CIRCUIT
K911736 · CAI
Medical Assemblies, Inc.
Anesthesiology · 85d
Cleared Jul 11, 1991
MEDICAL ASSEMBLIES MASS SPECT MONIT LINE/CONNECT
K911737 · CCK
Medical Assemblies, Inc.
Anesthesiology · 85d
Cleared Jul 11, 1991
MEDICAL ASSEMBLIES FILTER
K911738 · CAH
Medical Assemblies, Inc.
General Hospital · 85d
Cleared Jul 11, 1991
AMCATH DISPOSABLE MICRO SCISSORS
K912605 · GCJ
Intl. Medical, Inc.
General & Plastic Surgery · 29d
Cleared Jul 10, 1991
ADVANCE SUTURE ABSORBABLE GUT SUTURE
K903174 · GAE
Advance Suture, Inc.
General & Plastic Surgery · 357d
Cleared Jul 10, 1991
SLEEP I/T-5 AND SLEEP I/T-8
K904432 · BZQ
Cns, Inc.
Anesthesiology · 285d
Cleared Jul 10, 1991
HORIZON XL
K911616 · DRT
Mennen Medical, Inc.
Cardiovascular · 90d
Cleared Jul 10, 1991
CERADELTA
K911671 · EJS
Metalor Dental USA Corp.
Dental · 90d
Cleared Jul 09, 1991
ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE
K900385 · DSI
Parexel Intl. Corp.
Cardiovascular · 526d
Cleared Jul 09, 1991
MERIDIEN DENTAL SYSTEMS
K903488 · JEQ
Anco Merchandise Co., Ltd.
Dental · 342d
Cleared Jul 09, 1991
WATER COLUMN RELIEF VALVE
K904398 · CAF
Icn Pharmaceuticals, Inc.
Anesthesiology · 287d
Cleared Jul 09, 1991
BIOCERAM DENTAL IMPLANT, SERIES II
K904450 · DZE
Kyocera America, Inc.
Dental · 284d
Cleared Jul 09, 1991
CORDIS OPTA 5
K905698 · LIT
Cordis Corp.
Cardiovascular · 201d