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
154537–154560 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 29, 1983
CERAMCO * HIGH FUSING FOIL SOLDER
K833434 · EJS
Johnson & Johnson Professionals, Inc.
Dental · 85d
Cleared Dec 29, 1983
ETHYLENE OXIDE GAS STERILIZA SYS II
K833457 · FLF
Ben Venue Laboratories, Inc.
General Hospital · 85d
Cleared Dec 29, 1983
COMPUTED TOMOGRAPHY ORIENTED ROTARY ARC
K833484 · HAW
A. Patil, M.D.
Neurology · 83d
Cleared Dec 29, 1983
BLOOD OXYGENATOR HEAT EXHANGER COATING
K833518 · DTZ
American Bentley
Cardiovascular · 79d
Cleared Dec 29, 1983
PARTIAL PRESSURE ELECTRODE MEASUREMENT
K833534 · CHL
Shaban Mfg. Co.
Chemistry · 93d
Cleared Dec 29, 1983
POTASSIUM SODIUM ANALYSIS PRODUCTS
K833535 · JJO
Shaban Mfg. Co.
Chemistry · 93d
Cleared Dec 29, 1983
PARTIAL PRESSURE ELECTRODE MEASUREMENT
K833536 · CHL
Shaban Mfg. Co.
Chemistry · 85d
Cleared Dec 29, 1983
GDC 1448 DEVELOPMENT NAME
K833596 · EJS
Deringer-Ney, Inc.
Dental · 78d
Cleared Dec 29, 1983
LEBLOND DIAMOND DENTAL BUR
K833598 · EJL
A & M Instruments, Inc.
Dental · 78d
Cleared Dec 29, 1983
CRYSTAR PORCELAIN
K833643 · EIH
Shofu Dental Corp.
Dental · 73d
Cleared Dec 29, 1983
GILLETTE SABRE SYRINGE
K833655 · FRN
Intermedics, Inc.
General Hospital · 70d
Cleared Dec 29, 1983
CARDIOPLEGIA SYSTEM CCS-XXX SERIES
K833662 · DTR
Gish Biomedical, Inc.
Cardiovascular · 72d
Cleared Dec 29, 1983
ACCURATE MEASUREMENT DEVICE EZ-AMD
K833673 · GCX
Sorensen Research
General Hospital · 72d
Cleared Dec 29, 1983
AMER. V. MUELLER SURGICALSTAPLES-CARTR
K833704 · GDW
American Heyer Schulte
General & Plastic Surgery · 72d
Cleared Dec 29, 1983
SERUM THYROTROPIN ASSAY KIT, TIPSEP-
K833713 · JLW
Nuclear Diagnostics, Inc.
Chemistry · 69d
Cleared Dec 29, 1983
RESPIRATORY ASSESSMENT SYSTEM
K833714 · BZL
Thoratec Laboratories Corp.
Anesthesiology · 69d
Cleared Dec 29, 1983
ETCHING GEL
K833718 · KLE
Johnson & Johnson Professionals, Inc.
Dental · 66d
Cleared Dec 29, 1983
ENZYMATIC CO2
K833724 · CIL
American Monitor Corp.
Chemistry · 66d
Cleared Dec 29, 1983
GOLD-PALLADIUM-SILVER BASED CAST/ALLOY
K833736 · EIS
Jeneric Ind.
Dental · 65d
Cleared Dec 29, 1983
C. PTH RADIOIMMUNOASSAY KIT-CPTHK
K833768 · CEW
Sorin Biomedica, Fiat, USA, Inc.
Chemistry · 63d
Cleared Dec 29, 1983
QEA SODIUM/POTASSIUM ANALYZER
K833776 · CEM
Bd Becton Dickinson Vacutainer...
Chemistry · 63d
Cleared Dec 29, 1983
SYVA ADVANCE CORTISOL ASSAY
K833932 · JFT
Syva Co.
Toxicology · 45d
Cleared Dec 29, 1983
ORION
K833941 · IYE
Cgr Medical Corp.
Radiology · 44d
Cleared Dec 29, 1983
ELECTRONIC GRAVITY 300VC
K833953 · LDR
Ivent Corp.
General Hospital · 43d