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

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175,820 results
123529–123552 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 16, 1991
SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4
K904965 · FSY
Smith & Nephew Equipment Group
General & Plastic Surgery · 72d
Cleared Jan 16, 1991
LAB-SITE SAFETY NEEDLE
K905018 · DQO
Telos Medical Corp.
Cardiovascular · 70d
Cleared Jan 16, 1991
MIDIGOLD 50
K905322 · EJT
Ivoclar North America, Inc.
Dental · 49d
Cleared Jan 16, 1991
HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSOR
K905393 · FWF
Frigitronics, Inc.
General & Plastic Surgery · 47d
Cleared Jan 16, 1991
AUTO SUTURE(R) ENDOSCOPIC LDS(TM) LIGATING DEVICE
K905587 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 34d
Cleared Jan 16, 1991
ECLIPSE ICA BUN
K905602 · CDQ
Biotope, Inc.
Chemistry · 34d
Cleared Jan 15, 1991
THE O-RING SYSTEM - ORS
K900099 · DZE
Attachments Intl., Inc.
Dental · 372d
Cleared Jan 15, 1991
9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM)
K903344 · DSP
Kontron Instruments, Inc.
Cardiovascular · 174d
Cleared Jan 15, 1991
HAWAIIAN SUPRACONDYLAR PLATE
K903697 · HRS
Medpac
Orthopedic · 153d
Cleared Jan 15, 1991
ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM
K903733 · LBR
Institute For Clinical Applications
Chemistry · 152d
Cleared Jan 15, 1991
SERIES 51 AND 53 DISPOSABLE PRESSURE TRANSDUCERS
K904777 · DRS
Baxter Healthcare Corp
Cardiovascular · 85d
Cleared Jan 15, 1991
AVI MODEL 600 SYRINGE PUMP, MODIFICATION
K904979 · FRN
3M Avi, Inc.
General Hospital · 76d
Cleared Jan 15, 1991
CLOSED SYSTEM FLUSH SET
K904994 · DXT
Argon Medical Corp.
Cardiovascular · 69d
Cleared Jan 15, 1991
LAB-SITE
K905017 · DQO
Telos Medical Corp.
Cardiovascular · 69d
Cleared Jan 15, 1991
HEWLETT PACKARD MODEL 5650C, CARDIO DATA MGMT SYST
K905100 · DQK
Hewlett-Packard Co.
Cardiovascular · 63d
Cleared Jan 15, 1991
DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD.
K905311 · DWD
Baxter Bentley Laboratories, Inc.
Cardiovascular · 48d
Cleared Jan 15, 1991
DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS
K905312 · DWF
Baxter Bentley Laboratories, Inc.
Cardiovascular · 48d
Cleared Jan 15, 1991
VARIOUS
K905319 · EJT
Ivoclar North America, Inc.
Dental · 48d
Cleared Jan 15, 1991
DEGUDENT GS
K905387 · EJT
Degussa AG
Dental · 46d
Cleared Jan 15, 1991
GLYC-AFFIN(TM)-GA
K905513 · LCP
Isolab, Inc.
Chemistry · 36d
Cleared Jan 15, 1991
CIBA CORNING ACS T4 IMMUNOASSAY
K905532 · CDX
Ciba Corning Diagnostics Corp.
Chemistry · 36d
Cleared Jan 15, 1991
PATIENT EXAMINATION GLOVES
K905551 · LYY
Johnson & Johnson Medical, Inc.
General Hospital · 35d
Cleared Jan 15, 1991
TECHLYTE ELECTROLYTE ANALYZER
K905600 · JGS
Technalysis, Inc.
Chemistry · 32d
Cleared Jan 15, 1991
SYSTEMATE CALCIUM (EPOS APPLICATION) #65409
K905659 · CIC
Em Diagnostic Systems, Inc.
Chemistry · 29d