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
141937–141960 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 1986
ADVANCED NUCLEAR COMPUTER
K862842 · LMB
Advanced Nuclear Imaging Corp.
Radiology · 90d
Cleared Oct 27, 1986
SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE
K862861 · HHR
Directed Energy, Inc.
Obstetrics & Gynecology · 90d
Cleared Oct 27, 1986
SPIROLOOP-PULMONARY EXERCISE SYSTEM
K863087 · BTY
Pneumedics, Inc.
Anesthesiology · 76d
Cleared Oct 27, 1986
THERATRON-PHOENIX
K863180 · IWB
Aecl Medical
Radiology · 70d
Cleared Oct 27, 1986
ERS SYSTEM
K863286 · LMB
General Electric Co.
Radiology · 63d
Cleared Oct 27, 1986
KODAK EKTASCAN LASER PRINTER, MODEL 100
K863629 · LMC
Eastman Kodak Company
Radiology · 40d
Cleared Oct 27, 1986
COTTON ROLLS, NON-STERILE
K863764 · EFN
The Medical Group, Inc.
Dental · 32d
Cleared Oct 27, 1986
SALIVA EJECTORS
K863768 · DYN
The Medical Group, Inc.
Dental · 32d
Cleared Oct 27, 1986
VENTICIS II
K863778 · IYT
Cis-Us, Inc.
Radiology · 31d
Cleared Oct 27, 1986
IVORY PREMIUM RUBBER DAM
K863816 · EIE
Columbus Dental Mfg. Co.
Dental · 27d
Cleared Oct 27, 1986
MODELS 4002/4102/4202 OXY. DELIVERY/CO2 CANNULA
K863883 · CCK
Salter Labs
Anesthesiology · 21d
Cleared Oct 27, 1986
THE MMG 5 IN 1 CONNECTOR
K863912 · BYX
Medical Marketing Group
Anesthesiology · 19d
Cleared Oct 27, 1986
MAMMOGRAPHIC MODEL CXR 51 MO-6'/0.6 SH
K864042 · ITY
Absolute X-Ray Corp.
Radiology · 11d
Cleared Oct 24, 1986
SUNGLASSES (NON-PRESCRIPTION)
K860953 · HQY
Roseburg SA
Ophthalmic · 225d
Cleared Oct 24, 1986
MODEL 8-B CO2 LASER FOR OPTHALMIC & ORBITAL SURG
K862408 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 121d
Cleared Oct 24, 1986
PENN 3-RING HANDLE
K862729 · FFL
Penn Medical Devices, Inc.
Gastroenterology & Urology · 98d
Cleared Oct 24, 1986
MODEL 10-C W/LC-10A/U FOR OPHTHALMIC & ORBITAL USE
K862863 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 87d
Cleared Oct 24, 1986
MODEL 20-C W/FL-20A/U FOR SURGERY & DERMATOLOGY
K862864 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 87d
Cleared Oct 24, 1986
FLEXIBLE VISUALIZATION CATHETER
K862872 · FEI
American Edwards Laboratories
Gastroenterology & Urology · 86d
Cleared Oct 24, 1986
PERFECT ONE
K862930 · EJH
North American Alloys, Inc.
Dental · 81d
Cleared Oct 24, 1986
ANA-ENZYME IMMUNOASSAY (ANA-EIA) DIAGNOSTIC KIT
K862969 · LJM
Biohytech International, Inc.
Immunology · 79d
Cleared Oct 24, 1986
4-WIRE (CARSON) STONE EXTRACTOR
K863081 · FFL
Cook Urological, Inc.
Gastroenterology & Urology · 73d
Cleared Oct 24, 1986
(STAMEY) T.U.R.P. SUPRAPUBIC CATHETER SET
K863120 · KOB
Cook Urological, Inc.
Gastroenterology & Urology · 71d
Cleared Oct 24, 1986
MODEL 1350 URODYNAMIC WAVEFORM PROCESSOR
K863167 · FAP
Life-Tech Intl., Inc.
Gastroenterology & Urology · 67d