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
170737–170760 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 31, 1978
GLOVES, PROCEDURE
K781278 · FMC
Arbrook Mfg. Corp.
General Hospital · 37d
Cleared Aug 31, 1978
RABBIT ANTIBODY TO HUMAN T3
K781284 · CDP
Pcl-Ria, Inc.
Chemistry · 36d
Cleared Aug 31, 1978
THYRO-SHURE
K781296 · JLW
Nuclear Medical Laboratories, Inc.
Chemistry · 35d
Cleared Aug 31, 1978
UREA NITROGEN
K781305 · CDW
Analytical & Research Chemicals, Inc.
Chemistry · 34d
Cleared Aug 31, 1978
UREA NITROGEN TEST KIT
K781306 · CDL
Analytical & Research Chemicals, Inc.
Chemistry · 34d
Cleared Aug 31, 1978
GLUCOSE DETERM. KIT
K781307 · CGA
Analytical & Research Chemicals, Inc.
Chemistry · 34d
Cleared Aug 31, 1978
GLUCOLOUR
K781308 · CGE
Analytical & Research Chemicals, Inc.
Chemistry · 34d
Cleared Aug 31, 1978
GOT PROCEDURE
K781309
Analytical & Research Chemicals, Inc.
Chemistry · 34d
Cleared Aug 31, 1978
HUMAN CHORIONIC GONADO.-BETA RIA KIT
K781310 · JHI
Diagnostics Biochem Canada, Inc.
Chemistry · 31d
Cleared Aug 31, 1978
LDH PROCEDURE
K781323
Analytical & Research Chemicals, Inc.
Chemistry · 31d
Cleared Aug 31, 1978
ALP TEST
K781324 · CIO
Analytical & Research Chemicals, Inc.
Chemistry · 31d
Cleared Aug 31, 1978
BLOOD LEVEL DETECTOR-MODEL 7601
K781330 · FJF
Bd Becton Dickinson Vacutainer...
Radiology · 29d
Cleared Aug 31, 1978
DIGOXIN RIA (PEG) KIT
K781335 · DOG
Ortho Diagnostics, Inc.
Immunology · 29d
Cleared Aug 31, 1978
GLUCOSE TEST
K781342 · CGA
Wako Intl., Inc.
Chemistry · 27d
Cleared Aug 31, 1978
ULTRAFILL- ULTRABOUND
K781345 · EBD
Demetron Research Corp.
Dental · 24d
Cleared Aug 31, 1978
PACER-TRACER PULSE WIDTH
K781349 · DTC
Instromedix, Inc.
Cardiovascular · 24d
Cleared Aug 31, 1978
ICS NORMAL CONTROL SERUM
K781355 · DGR
Beckman Instruments, Inc.
Chemistry · 24d
Cleared Aug 31, 1978
DISPOSABLE AEROSOL T BRIGGS ADAPTOR
K781395 · BZA
Inhal-O-Tech Medical Plastic
Anesthesiology · 17d
Cleared Aug 31, 1978
XOMED TRANSSPHENOIDAL HANDPIECE
K781418 · ERL
Xomed, Inc.
Ear, Nose, Throat · 15d
Cleared Aug 31, 1978
DUAL COMPONENT STANDARDS
K781423 · JIT
Abbott Laboratories
Chemistry · 14d
Cleared Aug 31, 1978
HAND-TROL CONNECTOR EXTENDER
K781429 · GEI
Aspen Laboratories, Inc.
General & Plastic Surgery · 10d
Cleared Aug 31, 1978
HEARING AID, UNITRON MODEL 975
K781434 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 10d
Cleared Aug 31, 1978
HEARING AID, UNITRON MODEL 958
K781439 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 13d
Cleared Aug 23, 1978
PORTABLE CLOSED WOUND SUCTION EVACUATOR
K780848 · GCY
Biomet, Inc.
General & Plastic Surgery · 92d