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
159193–159216 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 27, 1982
ENT FORCEPS
K822278 · GEN
Kelleher Corp.
General & Plastic Surgery · 29d
Cleared Aug 27, 1982
TS-000 ARTERIOVENOUS BLOOD TUBING SET
K822283 · KOC
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 28d
Cleared Aug 27, 1982
AUTOCUFF (PHOTOS ENCLOSED WITH 510K
K822286 · KZD
Partamed, Inc.
General Hospital · 28d
Cleared Aug 27, 1982
QUANTIMUNE HTSH IRMA
K822291 · JLW
Bio-Rad
Chemistry · 25d
Cleared Aug 27, 1982
RAICHEM LDH-L REAGENT
K822312 · CFJ
Reagents Applications, Inc.
Chemistry · 24d
Cleared Aug 27, 1982
ARGYLE MEDIASTINAL DRAIN
K822318 · GBS
Sherwood Medical Co.
General & Plastic Surgery · 24d
Cleared Aug 27, 1982
SPI-RISE
K822359 · BWF
Certified Respiratory Services, Inc.
Anesthesiology · 21d
Cleared Aug 27, 1982
CENTURION SKIN STAPLE REMOVER
K822365 · GDT
Tri-State
General & Plastic Surgery · 21d
Cleared Aug 27, 1982
SYVA LAB PROCESSOR 6000
K822381 · JQP
Syva Co.
Toxicology · 18d
Cleared Aug 27, 1982
ST. MARK'S RECTAL BIOPSY FORCEPS
K822401 · KOA
Keymed, Inc.
Gastroenterology & Urology · 17d
Cleared Aug 27, 1982
AES STOCKINGS
K822446 · DWL
Rampon Products
General Hospital · 11d
Cleared Aug 25, 1982
STIMRITE
K821691 · EPF
Biotone International, Inc.
Ear, Nose, Throat · 78d
Cleared Aug 25, 1982
QUINTON Q, SCAN MODELS 900 & 901
K821758 · DPS
Quinton, Inc.
Cardiovascular · 71d
Cleared Aug 25, 1982
STERILE URETHRAL CATHETERIZATION SET
K821978 · KNX
Medical Devices, Inc.
Gastroenterology & Urology · 50d
Cleared Aug 25, 1982
AUDIOMETERS (VARIOUS MODELS)
K822177 · GWJ
Kelleher Corp.
Neurology · 33d
Cleared Aug 25, 1982
MACKENZIE'S TONSILLECTOME
K822186 · KCA
Kelleher Corp.
Ear, Nose, Throat · 33d
Cleared Aug 25, 1982
MIRCOSURGICAL INSTRUMENTS
K822195 · JYL
Kelleher Corp.
Ear, Nose, Throat · 33d
Cleared Aug 25, 1982
MALLEUS NIPPERS
K822198 · JEK
Kelleher Corp.
Ear, Nose, Throat · 33d
Cleared Aug 25, 1982
EAR SNARES
K822199 · JZD
Kelleher Corp.
Ear, Nose, Throat · 33d
Cleared Aug 25, 1982
DISPOSABLE TAIYANG SYRINGE
K822238 · FMF
S.D. Sunnyland Enterprises, Inc.
General Hospital · 28d
Cleared Aug 25, 1982
RASPS
K822253 · JYY
Kelleher Corp.
Ear, Nose, Throat · 27d
Cleared Aug 25, 1982
RIGID SUCTION TIPS
K822255 · KTR
Kelleher Corp.
Ear, Nose, Throat · 27d
Cleared Aug 25, 1982
ESOPHAGEAL BOUGIES
K822258 · KCD
Kelleher Corp.
Ear, Nose, Throat · 27d
Cleared Aug 25, 1982
ADENOTOMES
K822262 · KBH
Kelleher Corp.
Ear, Nose, Throat · 27d