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
174673–174696 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 29, 1976
PNEUMOTACHOGRAPHY SYSTEM
K760816 · GWB
Aftercal, Inc.
Microbiology · 17d
Cleared Oct 29, 1976
TRACOR MODEL RA 208 COMPLIANCE AUDIOM
K760859 · EWO
Tracor Instruments, Inc.
Ear, Nose, Throat · 11d
Cleared Oct 28, 1976
MONITOR, RESPIRATORY (CPAP)
K760339 · BZQ
Sherwood Medical Industries
Anesthesiology · 90d
Cleared Oct 28, 1976
HEMAFLOUR ZP
K760506 · KHO
Buchler Instruments, Inc.
Chemistry · 66d
Cleared Oct 27, 1976
JAR, COLLECTOR FOR SUCTION SYSTEMS
K760333 · GCX
Harris-Lake, Inc.
General Hospital · 90d
Cleared Oct 27, 1976
TEST, LACTATE DEHYDROGENASE
K760345 · CFJ
Princeton Biomedix
Chemistry · 86d
Cleared Oct 27, 1976
ASSAY FOR GAMMA GLUTAMYLTRANSFERASE
K760346 · JPZ
Princeton Biomedix
Chemistry · 86d
Cleared Oct 27, 1976
REAGENT SYSTEM, SIGMA PROCEDURE NO. 270
K760348 · CCZ
Sigma Chemical Co.
Chemistry · 86d
Cleared Oct 27, 1976
SKIN CLIP SYSTEM, DISPOSABLE (AVLOX ICI)
K760357 · FZG
V. Mueller O.V. Baxter Healthcare Corp.
General & Plastic Surgery · 86d
Cleared Oct 27, 1976
DIALYZER (MODEL 1850)
K760374 · FHS
Erika, Inc.
Gastroenterology & Urology · 83d
Cleared Oct 27, 1976
COIL MACHINE ADAPTER
K760725 · FLC
Gambro, Inc.
Gastroenterology & Urology · 30d
Cleared Oct 27, 1976
CONDUCTIVE ANESTHESIA BREATHING CIRCUIT
K760819 · CAI
Omnicon Medical Corp.
Anesthesiology · 15d
Cleared Oct 27, 1976
SOLO-SPHERE HEATER
K760845 · CAF
Respiratory Therapy
Anesthesiology · 13d
Cleared Oct 22, 1976
LIBERATOR/STROLLER
K760787 · BYJ
Burditt & Calkins-Siemens-Elema
Anesthesiology · 16d
Cleared Oct 21, 1976
CASE, CONTACT LENS, PLASTIC
K760046 · HPX
Tomlin B. Horsley, Jr.
Ophthalmic · 128d
Cleared Oct 21, 1976
FISTULA NEEDLE (#11-265)
K760665 · KOC
Cobe Laboratories, Inc.
Gastroenterology & Urology · 34d
Cleared Oct 21, 1976
INDIRECT FLUORESCENT (IFA-ANA)
K760681 · DHN
Wampole Laboratories
Immunology · 31d
Cleared Oct 21, 1976
SPONGE AND GAUZE FORCEP PART #S-417-9
K760703 · GEN
Acme United Corp.
General & Plastic Surgery · 28d
Cleared Oct 21, 1976
EMIT DIGOKIN ASSAY
K760709 · DOG
Syva Co.
Toxicology · 27d
Cleared Oct 21, 1976
FLEXIBLE CUTTING SCISSORS
K760715 · KOA
V. Mueller O.V. Baxter Healthcare Corp.
Gastroenterology & Urology · 26d
Cleared Oct 21, 1976
FLEXIBLE BIOPSY FORCEPS
K760717 · KOA
V. Mueller O.V. Baxter Healthcare Corp.
Gastroenterology & Urology · 26d
Cleared Oct 21, 1976
SAFE-T-PINS RETENTIVE PIN SYSTEM
K760723 · EBL
Parkell, Inc.
Dental · 24d
Cleared Oct 21, 1976
ULTRASONIC DENTAL PROPHYLAXIS DEVICE
K760805 · ELC
Cavitron Corp.
Dental · 9d
Cleared Oct 21, 1976
REFEREE AQUEOUS TRIGLYCERIDE STND
K760806 · JIS
Analytical Products, Inc.
Chemistry · 9d