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
166441–166464 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 30, 1980
1,3 & 4 WAY STERILE DIS. PLASTIC PKG.
K800862 · FMG
Custom Medical Devices Intl., Inc.
General Hospital · 44d
Cleared May 30, 1980
TANDEM ASSEMBED 3&4 WAY STERILE STOPCKS
K800863 · FMG
Custom Medical Devices Intl., Inc.
General Hospital · 44d
Cleared May 30, 1980
STERILE DISPOS. PLASTIC STOPCOCKS W/TUBE
K800864 · FMG
Custom Medical Devices Intl., Inc.
General Hospital · 44d
Cleared May 30, 1980
WOLFF SYSTEM
K800896 · LEJ
Wolff System GmbH
Radiology · 42d
Cleared May 30, 1980
JOHNLOZ ENDOSCOPY HANDLE
K800915 · KNS
Endoscopic Surgical Accessories, Inc.
Gastroenterology & Urology · 39d
Cleared May 30, 1980
MIDSTREAM COLLECTION KIT
K800947 · FMH
Sage Products, Inc.
General Hospital · 38d
Cleared May 30, 1980
TUBE FEEDING CONTAINER 1500 ML DISPOSE.
K800955 · KNT
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 37d
Cleared May 30, 1980
GAMBRO G SERIES BLOOD LINE SETS FOR HEM.
K801016 · FJK
Gambro, Inc.
Gastroenterology & Urology · 31d
Cleared May 30, 1980
ODOR MASKING AGENT FOR CONTENTS OF ALL
K801025 · FYA
The Buckeye Cellulose Corp.
General Hospital · 32d
Cleared May 30, 1980
TANNING BOOTH/TANS BY TANIQUE
K801034
Dawa Enterprises, Inc.
Radiology · 28d
Cleared May 30, 1980
UNICUF, BLOOD PRESSURE CUFF
K801099 · DXQ
Frontier Products
Cardiovascular · 21d
Cleared May 30, 1980
DOUBLE ENDED FILTERED TRANSFER NEEDLE
K801107 · FMI
Burron Medical Products, Inc.
General Hospital · 21d
Cleared May 30, 1980
DOUBLE ENDED VENTED TRANSFER DEVICE
K801108 · FMI
Burron Medical Products, Inc.
General Hospital · 21d
Cleared May 30, 1980
PROOF (BIOLOGICAL/CHEMICAL INDICATOR)
K801109 · JOJ
Amsco Co.
General Hospital · 18d
Cleared May 30, 1980
MACROVAC
K801127 · JOL
Progress Mankind Technology
General Hospital · 18d
Cleared May 30, 1980
MICROVAC
K801134 · JOL
Progress Mankind Technology
General Hospital · 18d
Cleared May 30, 1980
VOLU-SOL URINARY DICHROME STAIN
K801143 · IDA
Volu Sol Medical Industries
Pathology · 12d
Cleared May 30, 1980
FLOW MED 160
K801179 · FPA
D.R.O. Medical, Inc.
General Hospital · 14d
Cleared May 30, 1980
WRIGHTS RAPID STAIN
K801212 · IAF
Mcb Manufacturing Chemists, Inc.
Hematology · 10d
Cleared May 30, 1980
HAMILTON TUCKAWAY DESK
K801214 · KNO
Orthopedic Systems, Inc.
Physical Medicine · 10d
Cleared May 30, 1980
SKIL-CARE GEL WEDGE, FLOTATION PAD
K801217 · KIC
Skil-Care Corp.
Physical Medicine · 9d
Cleared May 28, 1980
PERM. INPLANT ENDOCARD. PAC. LEAD
K800347 · DTB
Daig Corp.
Cardiovascular · 103d
Cleared May 28, 1980
UNIPOLAR LEAD CONFIGURATION CONDUCTOR
K800348 · DTB
Daig Corp.
Cardiovascular · 103d
Cleared May 28, 1980
ENDOCARD. PACING LEAD LONG LENGTH PL200
K800349 · DTB
Diag Corp.
Cardiovascular · 103d