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
167377–167400 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 29, 1980
ALKALINE PHOSPHATASE MARKER
K792548 · CIN
Electrophoresis Corp. of America
Chemistry · 50d
Cleared Jan 29, 1980
ALKALINE PHOSPHATASE REAGENT
K792551 · CJH
Electrophoresis Corp. of America
Chemistry · 50d
Cleared Jan 29, 1980
AGAROSE BARBITAL-EDTA BUFFER
K792553 · JJN
Electrophoresis Corp. of America
Chemistry · 50d
Cleared Jan 29, 1980
UNISPORE-BIOLOGICAL INDICATORS
K792649 · FRC
Castle Co.
General Hospital · 39d
Cleared Jan 29, 1980
1500 EO EXHAUST HOOD
K792660 · FLF
Castle Co.
General Hospital · 33d
Cleared Jan 29, 1980
PIXIE
K792665 · IZL
Porta Ray, Inc.
Radiology · 33d
Cleared Jan 29, 1980
COULTER COUNTER-BLOOD CELL COUNTER
K792668 · GKL
Coulter Electronics, Inc.
Hematology · 33d
Cleared Jan 29, 1980
RIONET HEARING AID HE-71
K800011 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 25d
Cleared Jan 29, 1980
RIONET HEARING AID HA-61
K800012 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 25d
Cleared Jan 29, 1980
I.V. TAPE DOWN HOLDER
K800024 · KMK
Consolidated Medical Equipment, Inc.
General Hospital · 22d
Cleared Jan 29, 1980
LDC CONSTAMETRIC III HIGHT PRESS. SOL.
K800048 · KIE
Laboratory Data Control
Toxicology · 20d
Cleared Jan 29, 1980
H-I-M-TEST FOR DETECTING HUMAN CHOR. GON
K800055 · JHJ
Technam, Inc.
Chemistry · 19d
Cleared Jan 29, 1980
RITTER MODEL J DENTAL CHAIR
K800084 · KLC
Ritter Co.
Dental · 15d
Cleared Jan 29, 1980
PACEMAKER ELECTRODE INSERTER AIDE
K800088 · DTE
Telectronics, Inc.
Cardiovascular · 15d
Cleared Jan 28, 1980
HILO TRANS-X TRAUMA TRANSPORT
K792326 · IXR
Tecnomed, Inc.
Radiology · 70d
Cleared Jan 28, 1980
PORTARAY
K792535 · EAP
Siemens Corp.
Radiology · 52d
Cleared Jan 28, 1980
OBSTETRICAL BEDS
K792568 · KNC
Ets Rene Marzet
Obstetrics & Gynecology · 46d
Cleared Jan 28, 1980
COMPUTED TOMOGRAPHY X-RAY SCANNER
K792603 · JAK
Ohio Nuclear, Inc.
Radiology · 41d
Cleared Jan 28, 1980
STERILIZATION PROCESS/MATERNITY PAD
K792627 · HIL
Procter & Gamble Mfg. Co.
Obstetrics & Gynecology · 40d
Cleared Jan 28, 1980
STERILIZATION PROCESS/DBL. GRIP CORD CLP
K792631 · KNA
Procter & Gamble Mfg. Co.
Obstetrics & Gynecology · 40d
Cleared Jan 28, 1980
HIGH RESOLUTION IMAGING SYSTEM
K792638 · IYO
Unirad Corp.
Radiology · 39d
Cleared Jan 28, 1980
HYDRO PULSE MASSAGE
K792641 · ILJ
Hydro-Pulse Research, Inc.
Physical Medicine · 33d
Cleared Jan 28, 1980
THE VARIABLE LOAD KENETIC ENERGIZER
K792642 · ION
W.F. Pogue
Physical Medicine · 33d
Cleared Jan 28, 1980
TRIOSKOP
K792645 · IXR
Siemens Corp.
Radiology · 33d