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
165025–165048 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 1980
COMBUNED CALCIUM AND PHOSPHORUS STD.
K802824 · JIX
Mallinckrodt Critical Care
Chemistry · 31d
Cleared Dec 11, 1980
COMBINED GLUCOSE AND BUN STANDARDS
K802825 · JIX
Mallinckrodt Critical Care
Chemistry · 31d
Cleared Dec 11, 1980
BOUIE ELECTROSURGICAL TIP CLEANER
K802827 · GEI
Sybron Corp.
General & Plastic Surgery · 31d
Cleared Dec 11, 1980
COMPU-CHEM II CHEMISTRY ANALYZER
K802835 · JJE
Diagnostic Aids, Inc.
Chemistry · 29d
Cleared Dec 11, 1980
SERIES 1800 EXERCISE TREADMILL
K802836 · IOL
Marquette Electronics, Inc.
Physical Medicine · 29d
Cleared Dec 11, 1980
STERNUM SAW BLADE
K802838 · GFA
Amsco Co.
General & Plastic Surgery · 29d
Cleared Dec 11, 1980
CARDIOPLEGIA COOLING SYST. CCAS-2
K802848 · DTR
Bentley Laboratories, Inc.
Cardiovascular · 29d
Cleared Dec 11, 1980
BECKMAN ICS DRUG CONTROL SERA
K802854 · DIF
Beckman Instruments, Inc.
Chemistry · 28d
Cleared Dec 11, 1980
IMMULON REMOVAWELL STRIPS #011-010-6301
K802857 · JTC
Dynatech Corp.
Microbiology · 29d
Cleared Dec 11, 1980
POST OP. SPONGES STERILE
K802860 · EFQ
Abco Dealers, Inc.
General & Plastic Surgery · 29d
Cleared Dec 11, 1980
COMBINATION PADS STERILE SINGLES
K802861 · EFQ
Abco Dealers, Inc.
General & Plastic Surgery · 29d
Cleared Dec 11, 1980
GAUZE PADS STERILE SINGLES
K802862 · EFQ
Abco Dealers, Inc.
General & Plastic Surgery · 29d
Cleared Dec 11, 1980
GAUZE SPONGES
K802863 · EFQ
Abco Dealers, Inc.
General & Plastic Surgery · 29d
Cleared Dec 11, 1980
BACKTRAC 90-90 TRACTION
K802869 · KQZ
Backtrac
Orthopedic · 27d
Cleared Dec 11, 1980
TIBIAL FRACTURE BRACE
K802871 · IQI
Orthomedics
Physical Medicine · 27d
Cleared Dec 11, 1980
AUFRANC-TURNER ATS TOTAL HIP SYSTEM
K802872 · JDI
Howmedica Corp.
Orthopedic · 27d
Cleared Dec 11, 1980
CULTURE MEDIA FOR IN VITRO DIAG. USE
K802892 · JSG
Radiation Technology, Inc.
Microbiology · 24d
Cleared Dec 10, 1980
DIALYSIS CONTROL UNIT-CENTRY 2000
K802250 · FKP
Cobe Laboratories, Inc.
Gastroenterology & Urology · 85d
Cleared Dec 10, 1980
DIOSCAN
K802341 · IYO
Sonometrics Systems, Inc.
Radiology · 75d
Cleared Dec 10, 1980
LIQUISOL TESTOSTERONE RADIOIMM. TEST KIT
K802661 · CDZ
Damon Corp.
Chemistry · 43d
Cleared Dec 10, 1980
TRANSCUTANEOUS ELECTRIC NERVE STIMULATOR
K802678 · GZJ
General Medical Industries, Inc.
Neurology · 42d
Cleared Dec 10, 1980
LANCER URIC ACID AUTO/STAT KIT
K802692 · KNK
Sherwood Medical Co.
Chemistry · 41d
Cleared Dec 10, 1980
OREIA-Q-TY, ENZYME IMMUNOASSAY
K802693 · KLI
Organon, Inc.
Chemistry · 41d
Cleared Dec 10, 1980
NEONATAL PHOTOTHERAPY UNIT
K802702 · LBI
Ohio Medical Products
General Hospital · 37d