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
140329–140352 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 19, 1987
DR.BRUNO LANGE MINI-HBA1 PHOTOMETER
K865055 · GKR
Diversa Corp.
Hematology · 85d
Cleared Mar 19, 1987
CONTRASYL IMPRESSION MATERIAL
K870011 · ELW
Contracap
Dental · 76d
Cleared Mar 19, 1987
STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO.
K870158 · CEC
American Dade
Chemistry · 65d
Cleared Mar 19, 1987
SOFT EAR STETHOSCOPE
K870600 · CBG
Kalajian Ent.
Anesthesiology · 37d
Cleared Mar 19, 1987
ACA HUMAN CHORIONIC GONADOTROPIN (HCG) CALIBRATOR
K870673 · JIT
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 28d
Cleared Mar 19, 1987
CENTRIPREP CONCENTRATOR
K870690 · JJH
Amicon, Inc.
Chemistry · 28d
Cleared Mar 19, 1987
COAT-A-COUNT COCAINE METABOLITE TKCN1 & TKCN5
K870740 · KLN
Diagnostic Products Corp.
Toxicology · 22d
Cleared Mar 19, 1987
MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206
K870809 · GCZ
Adept-Med Intl., Inc.
General & Plastic Surgery · 16d
Cleared Mar 19, 1987
EASY-TEST URIC ACID (URIC) #16606
K870868 · KNK
Em Diagnostic Systems, Inc.
Chemistry · 16d
Cleared Mar 19, 1987
COAT-A-COUNT PCP KIT NUMBER TKPC1
K870875 · LCN
Diagnostic Products Corp.
Toxicology · 16d
Cleared Mar 19, 1987
ALANINE TRANSAMINASE (ALT) TEST KIT
K870879 · CKA
Genetic Systems Corp.
Chemistry · 15d
Cleared Mar 19, 1987
STEADY RESIN
K870908 · EBI
Great Lakes Orthodontics, Ltd.
Dental · 14d
Cleared Mar 19, 1987
COAT-A-COUNT METHAQUALONE TKMQ1
K870935 · KXS
Diagnostic Products Corp.
Toxicology · 10d
Cleared Mar 19, 1987
COAT-A-COUNT BARBITURATES TKBA1 AND TKBA5
K870936 · DIS
Diagnostic Products Corp.
Toxicology · 10d
Cleared Mar 19, 1987
COAT-A-COUNT METHADONE TKMD1
K870937 · DJR
Diagnostic Products Corp.
Toxicology · 10d
Cleared Mar 19, 1987
RICHARDS EXTERNAL FIXATION SYSTEM
K870961 · KTT
Richards Medical Co., Inc.
Orthopedic · 9d
Cleared Mar 19, 1987
T-TUBE INSERTER
K870978 · JYM
Sur-Med Instruments, Inc.
Ear, Nose, Throat · 9d
Cleared Mar 19, 1987
SEWON DENTAL FLOSSER
K870996 · JES
Sewon Industry
Dental · 8d
Cleared Mar 18, 1987
THE EXPERIMENTAL
K864455 · EFW
Martin H. Kaufmann
Dental · 126d
Cleared Mar 18, 1987
BONDEX* GLASS IONOMER CEMENT
K870211 · EMA
Johnson & Johnson Professionals, Inc.
Dental · 57d
Cleared Mar 18, 1987
PERCUTANEOUS INTRODUCER W/SIDE PORT 3 WAY STOPCOCK
K870374 · DYB
Daig Corp.
Cardiovascular · 48d
Cleared Mar 18, 1987
AARON C SIZE(TM) HIGH TEMPERATURE CAUTERY
K870397 · GEI
Sunkey Medical Manufacturing, Inc.
General & Plastic Surgery · 44d
Cleared Mar 18, 1987
O.B. SLENDER REGULAR TAMPON
K870539 · HEB
Personal Products Co.
Obstetrics & Gynecology · 37d
Cleared Mar 18, 1987
BUR BRUSH
K870760
Treace Medical, Inc.
General & Plastic Surgery · 20d