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
152065–152088 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 1984
TRIGLYCERIDES-GPO REAGENT
K842029 · CDT
Reagents Applications, Inc.
Chemistry · 52d
Cleared Jul 09, 1984
VENTREZYME PHENYTOIN KIT IMMUNOASSAY
K842161 · DIP
Ventrex Laboratories, Inc.
Chemistry · 40d
Cleared Jul 09, 1984
TBG RIA
K842167 · CEE
Syncor Intl. Corp.
Chemistry · 39d
Cleared Jul 06, 1984
STERILE HICHMAN/BROVIAC INJECTION CAP
K840846 · LJS
Evermed, Inc.
General Hospital · 133d
Cleared Jul 06, 1984
MULTIVARIATE DIGITAL CARDIOGRAPH
K840875 · DQK
Clinical Microsystems Intl.
Cardiovascular · 130d
Cleared Jul 06, 1984
BEHRING ELISA PROCESSOR M
K841043 · JQW
Behring Diagnostics, Inc.
Chemistry · 116d
Cleared Jul 06, 1984
HOSPAL BIOSPAL SCU/CAVH KIT
K841152 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 109d
Cleared Jul 06, 1984
CURITY RIG FOLEY CATH TRAY
K841169 · KNX
The Kendal Co.
Gastroenterology & Urology · 109d
Cleared Jul 06, 1984
DACOMED RIGISCAN SYSTEM
K841202 · LIL
Dacomed Corp.
Gastroenterology & Urology · 107d
Cleared Jul 06, 1984
PULSE GENERATOR 678L
K841233 · DXY
Siemens Elema AB
Cardiovascular · 106d
Cleared Jul 06, 1984
RECTAL IRRIGATION TUBE
K841289 · KNT
Hdc Corp.
Gastroenterology & Urology · 100d
Cleared Jul 06, 1984
CAUSSE SPONGE BOAT
K841353 · ETB
Treace Medical, Inc.
Ear, Nose, Throat · 95d
Cleared Jul 06, 1984
CURETTE
K841354 · JYG
Treace Medical, Inc.
Ear, Nose, Throat · 95d
Cleared Jul 06, 1984
HEMO-RO WATER PURIFICATION SYS
K841403 · FIP
Millipore Corp.
Gastroenterology & Urology · 94d
Cleared Jul 06, 1984
RADIOGRAPHIC FILM PROCESSOR M-30CR &
K841431 · IXX
The Allen Products Co.
Radiology · 91d
Cleared Jul 06, 1984
SCANLAN ATRAUM INSTRUMENT JAW COVER
K841513
Scanlan Intl., Inc.
General & Plastic Surgery · 85d
Cleared Jul 06, 1984
SENTECH'S ULAB 1000 CLINICAL CHEM.
K841575 · CEM
Sen Tech Medical Corp.
Chemistry · 80d
Cleared Jul 06, 1984
BP TRAUMA AIR PANTS
K841605 · LHX
Bp Medical Systems, Inc.
Anesthesiology · 78d
Cleared Jul 06, 1984
NON-CORING NEEDLE
K841742 · FMI
Creative Care Systems, Inc.
General Hospital · 70d
Cleared Jul 06, 1984
LIEBEL-FLARSHEIM ACS 1000 CHEST X-RAY
K841756 · KPR
Syvron Corp.
Radiology · 70d
Cleared Jul 06, 1984
HEPARIN CAP, INJECTION CAP MALE LUER-
K841772 · FPA
Linton Biomed Corp.
General Hospital · 67d
Cleared Jul 06, 1984
CLINICAL ELECTRONIC THERMOMETER
K841780 · FLL
Fidelity Medical, Inc.
General Hospital · 67d
Cleared Jul 06, 1984
MARK5 ARTERIAL BLOOD GAS KIT
K841810 · FMF
Martell Medical Products, Inc.
General Hospital · 66d
Cleared Jul 06, 1984
CANNU-SKREEN-PRELIMINARY
K841831 · DKE
Biochemical Diagnostic, Inc.
Toxicology · 64d