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
163849–163872 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 14, 1981
KOVA TROL I HUMAN URINE (DRIED)
K810917 · JJW
Icl Scientific
Chemistry · 8d
Cleared Apr 14, 1981
RESPIRATORY INTENSIVE CARE SYSTEM (RICS)
K810927 · CCK
Allied Healthcare Products, Inc.
Anesthesiology · 8d
Cleared Apr 14, 1981
PERFRINGENS AGAR BASE
K810929 · JSI
Oxoid U.S.A., Inc.
Toxicology · 8d
Cleared Apr 14, 1981
SS AGAR (MODIFIED)
K810931 · JSI
Oxoid U.S.A., Inc.
Toxicology · 8d
Cleared Apr 14, 1981
VITOX
K810932 · JSK
Oxoid U.S.A., Inc.
Toxicology · 8d
Cleared Apr 14, 1981
VOTEL-JOHNSON AGAR (MODIFIED)
K810933 · JSI
Oxoid U.S.A., Inc.
Toxicology · 8d
Cleared Apr 11, 1981
SINGLE USE SELDINGER/COURNAND PERC. NDL
K810859 · DRE
Procedure Products, Inc.
Cardiovascular · 12d
Cleared Apr 10, 1981
DOPSCAN MODEL 1050
K810561 · DPW
Carolina Medical Electronics
Cardiovascular · 38d
Cleared Apr 10, 1981
SYNCHRONIZER #208
K810588 · IXO
Brattle Instrument Corp.
Radiology · 37d
Cleared Apr 10, 1981
NEURO-ECAT
K810589 · KPS
Eg&G Ortec, Inc.
Radiology · 37d
Cleared Apr 10, 1981
P.R.M. 80
K810590 · IZW
T.E.M. Instruments , Ltd.
Radiology · 37d
Cleared Apr 10, 1981
X-RAY COLLIMATING DEVICES
K810598 · IZW
Midmark Corp.
Radiology · 35d
Cleared Apr 10, 1981
PHARMALOG
K810698 · DSH
Circadian, Inc.
Cardiovascular · 25d
Cleared Apr 10, 1981
CHROMOPS FM-100 COLOR VISION TESTER
K810700 · HIT
Visidyne Corp.
Ophthalmic · 25d
Cleared Apr 10, 1981
PDS CARDIAC CALC. SOFTW. PROGR. #A3604AF
K810751 · BZC
General Electric Co.
Anesthesiology · 21d
Cleared Apr 10, 1981
SKIN STAPLE REMOVER
K810785 · KDC
Rowley Mfg. Co.
General & Plastic Surgery · 18d
Cleared Apr 10, 1981
THERMOMETER, ELECTRONIC CLINICAL
K810814 · FLL
Her-Mar, Inc.
General Hospital · 17d
Cleared Apr 10, 1981
NON-INVASIVE AMPLIFIER
K810828 · DRR
Henry Ford Hospital
Cardiovascular · 17d
Cleared Apr 08, 1981
PREHEPARINZED SYRINGE
K803302 · FMF
The University of Chicago
General Hospital · 99d
Cleared Apr 08, 1981
DENTAL CHEWING GUM (SUGARLESS)
K810037 · EJR
Mcdennan Oral Products, Inc.
Dental · 89d
Cleared Apr 08, 1981
BIO CONDYLAR TM KNEE
K810328 · JWH
Depuy, Inc.
Orthopedic · 58d
Cleared Apr 08, 1981
DEPUY SEGMENTALSPINAL SYSTEM
K810329 · KWP
Depuy, Inc.
Orthopedic · 58d
Cleared Apr 08, 1981
ANIMAL SERUM PRODUCTS
K810478 · KIS
Animal Health Laboratories, Inc.
Toxicology · 44d
Cleared Apr 08, 1981
SCRIPPSYSTEM C3 RID KIT
K810501 · CZW
Scripps-Miles, Inc.
Immunology · 43d