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
137713–137736 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 03, 1987
INTELECT 775
K872655 · IPF
Chattanooga Group, Inc.
Physical Medicine · 119d
Cleared Nov 03, 1987
IVAC NITROGLYCERIN & LIPID ADMIN. SET MODEL S75053
K872764 · FRN
Y
General Hospital · 113d
Cleared Nov 03, 1987
CANNABINOID ENZYME IMMUNOASSAY KIT
K872882 · LDJ
General Diagnostics
Toxicology · 104d
Cleared Nov 03, 1987
BLOOD NEEDLE HOLDER
K873569 · FMI
Sage Products, Inc.
General Hospital · 62d
Cleared Nov 03, 1987
3 RING ATTACHMENT FOR SYRINGES
K873709 · FMF
Condor Medical
General Hospital · 49d
Cleared Nov 03, 1987
DEKNATEL TEMPORARY CARDIAC PACING WIRE
K873728 · LDF
Deknatel, Inc.
Cardiovascular · 48d
Cleared Nov 03, 1987
MEDTRONIC CATHETER ACCESS PORT MODEL 8500
K873735 · LJT
Medtronic Vascular
General Hospital · 49d
Cleared Nov 03, 1987
THERMOCOUPLE ADAPTER
K873833 · FLL
Mallinckrodt Critical Care
General Hospital · 43d
Cleared Nov 03, 1987
AMERLITE TT3 ASSAY, LAN.0003/1003/2003
K873858 · CDP
Amersham Corp.
Chemistry · 42d
Cleared Nov 03, 1987
PHARMACIA DELTEC SUBCUTANEOUS INFUSION SET
K873885 · FPA
Pharmacia Deltec, Inc.
General Hospital · 41d
Cleared Nov 03, 1987
TSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1093
K874061 · JLW
Medix Biotech, Inc.
Chemistry · 29d
Cleared Nov 03, 1987
TITAN GEL REP CPK-30 HV
K874139 · CGS
Helena Laboratories
Chemistry · 21d
Cleared Nov 03, 1987
TITAN GEL REP SIMULTANEOUS CK-LD ISOENZYME PROCED.
K874140 · CGS
Helena Laboratories
Chemistry · 21d
Cleared Nov 03, 1987
ANATOMIC TOTAL HIP
K874229 · JDI
Zimmer, Inc.
Orthopedic · 19d
Cleared Nov 03, 1987
DYNATECH MR 300 MANUAL MICROELISA
K874244 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 18d
Cleared Nov 03, 1987
BIFURCATED NEEDLE
K874249 · FMI
Allergy Laboratories of Ohio, Inc.
General Hospital · 18d
Cleared Nov 02, 1987
MAXIMUM, LATEX PROPHYLACTIC BRAND
K872005 · HIS
Safe Product Supplies
Obstetrics & Gynecology · 160d
Cleared Nov 02, 1987
RAYLOR FUSION FUNNEL
K872281 · HXR
Cedar Surgical, Inc.
General & Plastic Surgery · 139d
Cleared Nov 02, 1987
THE CART
K872533 · HRX
Arthropedics, Inc.
Orthopedic · 129d
Cleared Nov 02, 1987
TKS 4000 AUTO PERIMETER
K873122 · HPT
Vismed, Inc.
Ophthalmic · 84d
Cleared Nov 02, 1987
TOSHIBA, SMIT ROENTGEN
K873314 · ITY
Inland Tube Corp.
Radiology · 75d
Cleared Nov 02, 1987
VIDEO PRINTER SYSTEM
K873419 · KQM
Technology For Imaging, Inc.
General & Plastic Surgery · 68d
Cleared Nov 02, 1987
OBF MODEL 115 COMPUTER TONOMETER SYSTEM
K873422 · HKX
Ocular Blood Flow Laboratories, Inc.
Ophthalmic · 68d
Cleared Nov 02, 1987
ENTECH ENTERAL PUMP AND SET
K873444 · FRN
Entech, Inc.
General Hospital · 67d