FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
124561–124584 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 15, 1990
SYNCHRON CX4-CE
K904220 · JJE
Beckman
Chemistry · 33d
Cleared Oct 15, 1990
NOVA LITE TM THYROID
K904224 · JZO
Inova Diagnostics, Inc.
Immunology · 32d
Cleared Oct 15, 1990
HEATWAVE
K904252 · LGZ
Medadvances, Inc.
General Hospital · 28d
Cleared Oct 15, 1990
PROGUARD(TM) BLOOD COLLECTION NEEDLE
K904295 · FMI
Safety-Ject, Inc.
General Hospital · 26d
Cleared Oct 15, 1990
DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD
K904305 · LCD
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 26d
Cleared Oct 15, 1990
DUPONT DRUG CALIBRATOR-A
K904306 · JJX
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 26d
Cleared Oct 15, 1990
EUREKA EXTENSION CYLINDERS
K904489 · KPW
Eureka X-Ray Tube Corp.
Radiology · 13d
Cleared Oct 12, 1990
SYB, OR SAVE YOUR BREATH TONGUE CLEANER
K902164 · LCN
P.J., Inc.
Dental · 150d
Cleared Oct 12, 1990
VET (VACUUM ERECTION TECHNOLOGY)
K902240 · LKY
Vetco, Inc.
Gastroenterology & Urology · 147d
Cleared Oct 12, 1990
PULSED SELECTRON
K902533 · JAQ
Nucletron-Oldelft Corp.
Radiology · 126d
Cleared Oct 12, 1990
MILENIA (TM) LH
K902786 · CEP
Diagnostic Products Corp.
Chemistry · 108d
Cleared Oct 12, 1990
LAPAROSCOPIC ACCESS SHEATH SET
K903124 · HET
Cook, Inc.
Obstetrics & Gynecology · 88d
Cleared Oct 12, 1990
HYSTEROSCOPY SHEATH SET
K903146 · HIH
Cook, Inc.
Obstetrics & Gynecology · 86d
Cleared Oct 12, 1990
LAPAROSCOPIC CATHERTER
K903187 · HET
Cook Ob/Gyn
Obstetrics & Gynecology · 85d
Cleared Oct 12, 1990
STATLAB A-350 SALIVA ALCOHOL TEST
K903235 · DIC
Enzymatics C/O Burditt,Bowles,Radzius...
Toxicology · 81d
Cleared Oct 12, 1990
CONTINUUM KNEE SYSTEM (CKS)-MODIFICATION
K903286 · HSX
Techmedica, Inc.
Orthopedic · 88d
Cleared Oct 12, 1990
ROCHE COBAS READY GGT REAGENT
K903304 · JPZ
Roche Diagnostic Systems, Inc.
Chemistry · 80d
Cleared Oct 12, 1990
ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMM
K903391 · JLW
Nichols Institute
Chemistry · 77d
Cleared Oct 12, 1990
IL T UPTAKE ASSAY SYSTEM
K903396 · KHQ
Instrumentation Laboratory CO
Chemistry · 77d
Cleared Oct 12, 1990
TDX FREE T3 CALCULATION
K903433 · CDP
Abbott Laboratories
Chemistry · 73d
Cleared Oct 12, 1990
IR-192 IMPLANT
K903465 · KXK
Rads S.L., Inc.
Radiology · 72d
Cleared Oct 12, 1990
SYNERMED ALBUMIN REAGENT KIT
K903543 · CIX
Synermed, Inc.
Chemistry · 66d
Cleared Oct 12, 1990
V-LINK
K903608 · CAW
GE Medical Systems
Radiology · 64d
Cleared Oct 12, 1990
MODIFIED ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM
K903620 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 66d