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
160585–160608 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 12, 1982
CREATINE KINASE-MB KIT
K820812 · JHY
Calbiochem-Behring Corp.
Toxicology · 20d
Cleared Apr 09, 1982
CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY
K813033 · GKG
Bd Becton Dickinson Vacutainer...
Hematology · 163d
Cleared Apr 09, 1982
WATERS ILEOSTOMY VALVE
K813585 · KNT
Waters Instruments, Inc.
Gastroenterology & Urology · 102d
Cleared Apr 09, 1982
RELINER FOR HEARING AID EARMOLDS
K820185 · ESD
Aid-To-Hearing Corp.
Ear, Nose, Throat · 77d
Cleared Apr 09, 1982
TRANSTHORACIC TEMP. PACEMAKER #100TPE
K820232 · LDF
Trans Pace, Inc.
Cardiovascular · 71d
Cleared Apr 09, 1982
SAFE TDENT
K820245 · EBO
Professional Dental Studios
Dental · 70d
Cleared Apr 09, 1982
GOLD FOIL ERG ELECTRODES
K820254 · HLZ
Cadwell Laboratories, Inc.
Ophthalmic · 67d
Cleared Apr 09, 1982
PLASMA POOLER HEAT SEALER
K820301 · KSD
North American Biologicals, Inc.
Hematology · 64d
Cleared Apr 09, 1982
HEMOTEC HEPCON/SYSTEM FOUR & FOUR P
K820410 · LOX
Hemotec, Inc.
Hematology · 56d
Cleared Apr 09, 1982
E.R.C.P. CANNULAS
K820431 · ODD
American Endoscopy, Inc.
Gastroenterology & Urology · 51d
Cleared Apr 09, 1982
SYBRON BOVIE CSV HAND CONTR. ELECTROSURG
K820494 · GEI
Sybron Corp.
General & Plastic Surgery · 45d
Cleared Apr 09, 1982
BAUSCH & LOMB STERILE ALL PURPOSE SOLU
K820511 · HPX
Bausch & Lomb, Inc.
Ophthalmic · 45d
Cleared Apr 09, 1982
GELMAN GLYCO-PHORE BUFFER
K820518 · JBD
Gelman Sciences, Inc.
Chemistry · 43d
Cleared Apr 09, 1982
MUSCLE DYSFUNCTION MONITOR
K820568 · DZM
A Company, Inc.
Dental · 38d
Cleared Apr 09, 1982
ARGYLE DELEE SUCTION CATHETER W/MUCOUS
K820572 · KTR
Sherwood Medical Co.
Ear, Nose, Throat · 38d
Cleared Apr 09, 1982
ECONOMY LINE OF TRAYS
K820589 · FRG
Abco Dealers, Inc.
General Hospital · 36d
Cleared Apr 09, 1982
MICROSURGERY KNIFE
K820618 · HNN
Visitec Co.
Ophthalmic · 32d
Cleared Apr 09, 1982
ELECTROSTIMULI AVERSION MACHINE
K820622 · HCB
Michael R. Kiss
Neurology · 32d
Cleared Apr 09, 1982
HEMALET AUTOMATIC LANCET DEVICE
K820625 · FMK
Medprobe Laboratories
General & Plastic Surgery · 32d
Cleared Apr 09, 1982
OPTI-DISC
K820626 · KQM
Video-Medical Devices, Ltd.
General & Plastic Surgery · 32d
Cleared Apr 09, 1982
PEDIATRIC SUCKER
K820638 · KDC
3M Health Care, Sarns
General & Plastic Surgery · 32d
Cleared Apr 09, 1982
OBTURATION SYSTEM KIT
K820639 · EKM
U.S. Shizai Corp.
Dental · 32d
Cleared Apr 09, 1982
RIONET HEARING AID HA-57
K820656 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 31d
Cleared Apr 09, 1982
HS17/HS18 SERIES MONITORS
K820670 · FLL
Medtel Pty. , Ltd.
General Hospital · 29d