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
120073–120096 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 26, 1991
MINXRAY P300 X-RAY SYSTEM
K911841 · IZL
Minxray, Inc.
Radiology · 123d
Cleared Aug 26, 1991
J105 JAMES SURGICAL SYSTEM I/A PACK
K911932 · GZX
O.R. Specialties, Inc.
Neurology · 118d
Cleared Aug 26, 1991
OPEN HEART TRAY
K912053 · FSM
Medical Device Inspection Co., Inc.
General & Plastic Surgery · 109d
Cleared Aug 26, 1991
HEALY/MONTGOMERY STENT SYSTEM (HMS SYSTEM(TM))
K912290 · BTR
Boston Medical Products, Inc.
Anesthesiology · 95d
Cleared Aug 26, 1991
MULTICAM I 8X10
K912341 · JAA
Camtronics, Ltd.
Radiology · 94d
Cleared Aug 26, 1991
INTELIJET TM FLUID MANAGEMENT SYSTEM
K912453 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 84d
Cleared Aug 26, 1991
ATRIUM 2000 CHEST DRAIN
K912704 · KDQ
Atrium Medical Corp.
General Hospital · 68d
Cleared Aug 26, 1991
ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE
K912755 · DJP
Roche Diagnostic Systems, Inc.
Toxicology · 66d
Cleared Aug 26, 1991
DEVON SPONGE COUNTER BAGS
K912824 · LWH
Devon Industries, Inc.
General & Plastic Surgery · 61d
Cleared Aug 26, 1991
DIGISTORE 2100
K912896 · JAA
Enhanced Imaging Technologies, Inc.
Radiology · 56d
Cleared Aug 26, 1991
LIFECARE 4100 PCA INFUSER PLUS II
K912928 · FRN
Abbott Laboratories
General Hospital · 82d
Cleared Aug 26, 1991
BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY
K913091 · KQN
American Laboratory Products Co., Ltd.
Chemistry · 45d
Cleared Aug 26, 1991
EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS
K913190 · DLZ
Syva Co.
Toxicology · 39d
Cleared Aug 26, 1991
KODAK EKTACHEM DT SLIDES (ALB)
K913195 · CIX
Eastman Kodak Company
Chemistry · 39d
Cleared Aug 26, 1991
KODAK EKTACHEM DT SLIDES (LAC)
K913197 · KHP
Eastman Kodak Company
Chemistry · 39d
Cleared Aug 26, 1991
KODAK EKTACHEM DT SLIDES (CHE)
K913198 · DIH
Eastman Kodak Company
Chemistry · 39d
Cleared Aug 26, 1991
LITEBOX
K913252 · JAK
Siemens Gammasonics, Inc.
Radiology · 35d
Cleared Aug 26, 1991
URINE COLLECTION KIT/DEVICE
K913330 · KHP
Medical Implements, Inc.
Chemistry · 32d
Cleared Aug 26, 1991
ABUSCREEN(R) ONLINE(TM) CALIBRATORS
K913335 · DKB
Roche Diagnostic Systems, Inc.
Toxicology · 34d
Cleared Aug 26, 1991
ABUSCREEN(R) ONLINE(TM) CONTROLS
K913336 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 34d
Cleared Aug 26, 1991
MODIFICATION MANUAL RESUSCITATOR (PMR 2)
K913370 · BTM
Puritan Bennett Corp.
Anesthesiology · 28d
Cleared Aug 26, 1991
PHILIPS S1594 OTB HEARING AID
K913389 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 28d
Cleared Aug 26, 1991
M32 IN-THE-EAR HEARING AID
K913390 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 28d
Cleared Aug 26, 1991
EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORS
K913429 · DIP
Syva Co.
Toxicology · 25d