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
124993–125016 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 1990
TENCKHOFF PERITONEAL DIALYSIS KIT
K902203 · FJG
Akcess Medical Products, Inc.
Gastroenterology & Urology · 77d
Cleared Aug 01, 1990
ITE HEARING AID MODEL PALOMINO
K902290 · ESD
Improved Hearing Service, Inc.
Ear, Nose, Throat · 71d
Cleared Aug 01, 1990
SOFTWARE RELEASE 4.2P, ACCESS(TM)
K902310 · LNH
Toshiba America Mri, Inc.
Radiology · 70d
Cleared Aug 01, 1990
CERVICAL COIL MRT 50A
K902315 · LNH
Toshiba America Mri, Inc.
Radiology · 70d
Cleared Aug 01, 1990
KNEE QD COIL MRT 50A
K902316 · LNH
Toshiba America Mri, Inc.
Radiology · 70d
Cleared Aug 01, 1990
ELITE R/F SPOT FILM DRIVE
K902403 · IXL
Rms Div.
Radiology · 62d
Cleared Aug 01, 1990
SURELITE AND SURELITE XL BLOOD LANCET
K902416 · FMK
Gainor Medical Europe, Ltd.
General & Plastic Surgery · 62d
Cleared Aug 01, 1990
ACS 0.02 M CALCIUM CHLORIDE
K902458 · JPA
Analytical Control Systems, Inc.
Chemistry · 58d
Cleared Aug 01, 1990
DEGUFILL (TM) ETCHANT GEL
K902743 · EBF
Degussa AG
Dental · 40d
Cleared Aug 01, 1990
EXTENDED CHIN IMPLANT STYLE I
K902824 · FWP
Implantech Associates, Inc.
General & Plastic Surgery · 34d
Cleared Aug 01, 1990
EXTENDED CHIN IMPLANT STYLE II
K902825 · FWP
Implantech Associates, Inc.
General & Plastic Surgery · 34d
Cleared Aug 01, 1990
ANATOMICAL MANDIBULAR IMPLANT STYLE I
K902826 · FWP
Implantech Associates, Inc.
General & Plastic Surgery · 34d
Cleared Aug 01, 1990
ANATOMICAL MANDIBULAR IMPLANT STYLE II
K902827 · FWP
Implantech Associates, Inc.
General & Plastic Surgery · 34d
Cleared Aug 01, 1990
FASTRECON 88 PERIFERAL
K902848 · JAK
Scientific Technology , Ltd.
Radiology · 34d
Cleared Aug 01, 1990
POST CEMENT (DENTAL COMPOSITE)
K902894 · EMA
Medical Device Inspection Co., Inc.
Dental · 30d
Cleared Aug 01, 1990
MODIFIED COAG-1 PT TEST CARD
K903019 · GJS
Cardiovascular Diagnostic Services
Hematology · 21d
Cleared Aug 01, 1990
LATEX SURGICAL STERILE GLOVES
K903212 · KGO
Mirage Medical & Chemical, Inc.
General Hospital · 21d
Cleared Jul 31, 1990
SPBC SERIES SINGLE PASS BLOOD CARDIOPLEGIA SYSTEM
K896807 · DTR
Gish Biomedical, Inc.
Cardiovascular · 239d
Cleared Jul 31, 1990
ZAP-GUARD
K896985 · DRL
Guardian Angel Products, Inc.
Cardiovascular · 230d
Cleared Jul 31, 1990
MICRORING YT
K900112 · JXB
Medical Wire & Equipment Co.
Microbiology · 203d
Cleared Jul 31, 1990
EPICARDIA 4000
K900207 · DST
Medicomp, Inc.
Cardiovascular · 196d
Cleared Jul 31, 1990
APPLICARD (EKG)
K900459 · DRY
Medi-Globe Corp.
Cardiovascular · 182d
Cleared Jul 31, 1990
PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODE
K900682 · DRY
Contour Electrodes, Inc.
Cardiovascular · 168d
Cleared Jul 31, 1990
IONOMETER EF-HK AND ACCESSORIES
K901042 · JGS
Fresenius USA, Inc.
Chemistry · 147d