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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
119233–119256 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 30, 1991
C100 INFANT INCUBATOR SHELF/MOUNT RAIL SYSTEM
K912910 · FMZ
Air-Shields Vickers, Inc.
General Hospital · 120d
Cleared Oct 30, 1991
MINIFLEX AND PERSONAL UNIT
K912997 · EAZ
Dabi-Atlante America Corp.
Dental · 114d
Cleared Oct 30, 1991
REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172
K913058 · CEF
Helena Laboratories
Chemistry · 112d
Cleared Oct 30, 1991
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K913475 · LNH
GE Medical Systems
Radiology · 86d
Cleared Oct 30, 1991
SIEMENS MICRO2 PULSE OXIMETER
K913489 · DQA
Siemens Medical Electronics
Anesthesiology · 85d
Cleared Oct 30, 1991
COFFMAN TOMOGRAPH
K913652 · EHD
Coffman Dental
Radiology · 75d
Cleared Oct 30, 1991
PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED
K913718 · FRN
Abbott Laboratories
General Hospital · 90d
Cleared Oct 30, 1991
PANCRETEC I.V. MODEL 5500 INFUSER
K913719 · FRN
Abbott Laboratories
General Hospital · 90d
Cleared Oct 30, 1991
PANCRETEC PROVIDER ONE INFUSION SYSTEM, MODIFIED
K913720 · FRN
Abbott Laboratories
General Hospital · 90d
Cleared Oct 30, 1991
HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST
K913757 · KPR
Hologic, Inc.
Radiology · 70d
Cleared Oct 30, 1991
TCAL ABUTMENT
K913782 · DZE
Core-Vent Corp.
Dental · 75d
Cleared Oct 30, 1991
AUTOMATED BIOPSY DEVICE, MODIFICATION
K913815 · DWO
Hart Enterprises, Inc.
General & Plastic Surgery · 65d
Cleared Oct 30, 1991
FUJI II LC
K913884 · EMA
G-C Intl. Corp.
Dental · 62d
Cleared Oct 30, 1991
ASPIRATION/INJECTION NEEDLE
K913992 · GAA
Northgate Technologies, Inc.
General & Plastic Surgery · 55d
Cleared Oct 30, 1991
INFUCARE SYRINGE PUMP TUBING SET
K914034 · FRN
Infucare Products, Inc.
General Hospital · 50d
Cleared Oct 30, 1991
PHOSPHOLIPID REAGENT SET
K914040 · JNT
Sterling Diagnostics, Inc.
Chemistry · 50d
Cleared Oct 30, 1991
PEEPERS TANNING GOGGLES
K914095 · HOY
California Suncare, Inc.
General & Plastic Surgery · 48d
Cleared Oct 30, 1991
SINGLE USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT
K914120 · GCI
Conmedcorp
General & Plastic Surgery · 47d
Cleared Oct 30, 1991
CARDIOFOCAL COLLIMATOR
K914179 · KPS
Siemens Gammasonics, Inc.
Radiology · 42d
Cleared Oct 30, 1991
GEN-X 800/800
K914301 · IZO
Swissray Finatech, Inc.
Radiology · 35d
Cleared Oct 30, 1991
GEN-X 800/650
K914302 · IZO
Swissray Finatech, Inc.
Radiology · 35d
Cleared Oct 30, 1991
TROCAR
K914377 · GCJ
O.R. Concepts, Inc.
General & Plastic Surgery · 29d
Cleared Oct 30, 1991
ABUSCREEN(R) ONLINE(TM) FOR BARBITURATES
K914468 · DKN
Roche Diagnostic Systems, Inc.
Toxicology · 23d
Cleared Oct 30, 1991
CHOLESTECH LIPID MONIT SYST, TOTAL CHOL/TRIG PANEL
K914469 · CHH
Cholestech Corp.
Chemistry · 23d