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
158809–158832 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 13, 1982
SAFE LOCK TITANIUM ADAPTER SET
K822550 · FKX
American Medical Products, Inc.
Gastroenterology & Urology · 50d
Cleared Oct 13, 1982
AMP CAPD UNISPIKE AMINISTRATION SET
K822551 · FKK
American Medical Products, Inc.
Gastroenterology & Urology · 50d
Cleared Oct 13, 1982
INNOMED PD-1 KIT
K822574 · LJL
Innomed Corp.
General Hospital · 50d
Cleared Oct 13, 1982
TISSUE FORCEPS
K822591 · GEN
Medcare Products
General & Plastic Surgery · 35d
Cleared Oct 13, 1982
LAPAROTOMY SPONGE
K822623 · GDY
Hermitage Hospital Products, Inc.
General & Plastic Surgery · 44d
Cleared Oct 13, 1982
SYNTEVENT ATOMIZER/NEBULIZER AEROSOL
K822625 · CCQ
Syva Co.
Anesthesiology · 44d
Cleared Oct 13, 1982
TAMDEM-R THYROID STIMULATING HORMONE KIT
K822705 · JLW
Hybritech, Inc.
Chemistry · 36d
Cleared Oct 13, 1982
METABOLIC MEASUREMENT CART
K822710 · BZL
Beckman Instruments, Inc.
Anesthesiology · 36d
Cleared Oct 13, 1982
SUCTION TUBES
K822724 · BSY
Exco, Inc.
Anesthesiology · 36d
Cleared Oct 13, 1982
RT-200 CALIBRATION ANALYZER
K822746 · BXX
Timeter Instrument Corp.
Anesthesiology · 33d
Cleared Oct 13, 1982
HEARING AID, UNITRON MODEL UE7
K822805 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 26d
Cleared Oct 13, 1982
COMMAND BONDING RESIN/GLAZE/OPAQUER
K822869 · EBD
Sybron Corp.
Dental · 16d
Cleared Oct 13, 1982
PEDI-TUBE PEDIATRIC FEEDING TUBE
K822875 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 16d
Cleared Oct 08, 1982
GASTROCCULT TM
K821884 · KHE
Smithkline Diagnostics, Inc.
Hematology · 105d
Cleared Oct 08, 1982
HISTIMUNE ENZYME-ANA TEST
K822346 · LJM
Icl Scientific
Immunology · 63d
Cleared Oct 08, 1982
UNIMETER 330K
K822441 · CEM
Boehringer Mannheim Corp.
Chemistry · 53d
Cleared Oct 08, 1982
COUNT-10 TROL
K822540 · JJW
Texas Immunology, Inc.
Chemistry · 46d
Cleared Oct 08, 1982
SYRINGE PUMP
K822571 · FRN
Hirata Sangyo Co. USA, Inc.
General Hospital · 45d
Cleared Oct 08, 1982
ADVANCE TM T-3 UPTAKE ASSAY
K822592 · KHQ
Syva Co.
Chemistry · 31d
Cleared Oct 08, 1982
ENDAB THYROID UPTAKE
K822684 · CEE
Immunotech Corp.
Microbiology · 35d
Cleared Oct 08, 1982
FLUOROSTAT FLUOROMETER
K822701 · KHO
Miles Laboratories, Inc.
Chemistry · 31d
Cleared Oct 08, 1982
MODEL 340 SPECTROPHOTOMETER
K822720 · JJQ
Abbott Diagnostics
Chemistry · 31d
Cleared Oct 08, 1982
DEL MAR AVIONICS MODEL 551 NEUROCORDER
K822751
Del Mar Avionics
Cardiovascular · 25d
Cleared Oct 08, 1982
THERAPEUTIC DRUG CONTROL
K822777 · DIF
Icl Scientific
Toxicology · 24d